[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"esophageal-squamous-cell-carcinoma-escc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:esophageal-squamous-cell-carcinoma-escc":654},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,35,0,25,[9,45,66,91,117,143,170,200,225,263,287,307,355,375,397,421,444,468,496,523,545,565,585,614,632],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100053669",false,"NCT07697859","PD-1 Inhibitors Combined With Local Therapy at Different Timings in Oligometastatic ESCC","A Phase III Randomized Controlled Study Investigating the Combination of PD-1 Inhibitors With Local Therapy Administered at Distinct Treatment Timings Among Patients With Oligometastatic Esophageal Squamous Cell Carcinoma","ESO-shanghai31","Inclusion Criteria:\n\n1. An eastern cooperative oncology group (ECOG) score of 0-1.\n2. Histologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma.\n3. Genuine oligometastasis (without a history of polyme-tastatic disease).\n4. A total of four or fewer distant metastases, a maximum of three metastases in a single organ, and a maximum diameter of each metastatic lesion not exceeding 5 cm.\n5. Biopsy of a metastatic lesion, PET\u002FCT scan, and PD-L1 CPS (IHC 22C3) are not required but preferred.\n6. No history of anti-PD-1\u002FPD-L1 therapy. However, the following conditions are also eligible for inclusion: the use of anti-PD1\u002FPD-L1 during induction\u002Fneoadjuvant\u002F concurrent therapy, or the use of anti-PD1\u002FPD-L1 for maintenance therapy but not due to toxicity or disease progression interrupting anti-PD1\u002FPD-L1 treatment, and the interruption has lasted for more than 3 months.\n7. Adequate hematological, hepatic, renal, and coagula-tion function. Baseline laboratory tests required to assess eligibility, including ANC ≥ 1.5 × 10\\^9\u002FL, PLT ≥ 80 × 10\\^9\u002FL, Hb ≥85 g\u002FL, ALB ≥28 g\u002FL, TBIL ≤ 1.5 × ULN, ALT and AST ≤ 3 × ULN, Cr ≤ 1.5 × ULN or CrCl ≥40 mL\u002Fmin, FEV1 ≥ 1 L. (liver metastases ALT and AST ≤ 5 × ULN, liver or bone metastases AKP ≤ 5 × ULN).(9) Enrolled voluntarily and signed informed consent by the patient himself or his legal representative.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Lung V20 remains over 25%.\n3. Confirmed diagnosis or clinical suspicion of esophageal fistula.\n4. Recurrence in the irradiated field.\n5. Active infection requiring systemic therapy.\n6. Active autoimmune disease requiring systemic treat-ment in the past 2 years.\n7. Immunodeficiency diagnosis, systemic steroid therapy, or any immunosuppressive treatment within 7 days before the first study treatment dose.\n8. Patients with a known history of grade 3 or higher adverse events, which are unsuitable for Anti-PD-1 therapy or adverse events that have not recovered to ≤CTCAE grade 1 (except alopecia).\n9. Uncontrolled pleural effusion, pericardial effusion, or pelvic ascites requiring repeated drainage.\n10. Unable or rejection to receive Anti-PD-1 therapy or unable to comply with study requirements or follow-up schedule.(11) Inability to provide informed consent.\n\n    \\-","ALL","18 Years",{"count":20,"type":21},354,"ESTIMATED","2 Years","OBSERVATIONAL","Although immunotherapy combined with chemotherapy has become the first-line standard regimen for advanced esophageal squamous cell carcinoma (ESCC) and improved clinical outcomes in advanced patients, the prognosis of patients with esophageal cancer remains unsatisfactory, with a 5-year overall survival rate below 20%. As an effective modality for local disease control, local radiotherapy has no established optimal sequencing schedule when combined with systemic therapy. The timing of radiotherapy intervention may directly affect treatment efficacy, treatment tolerance and quality of life of patients.\n\nSeveral studies have explored the impact of radiotherapy timing in oligometastatic ESCC, yet substantial limitations persist in current evidence, resulting in a lack of unified guideline recommendations and wide heterogeneity in clinical practice. Most existing investigations are retrospective or small-sample prospective studies with high heterogeneity in study design, patient population selection and treatment regimens, yielding inconsistent conclusions that cannot support consistent clinical consensus.\n\nTo clarify the impact of radiotherapy timing on clinical efficacy in oligometastatic esophageal cancer, the investigator designed the present clinical trial. This study aims to compare the efficacy and safety of concurrent radiotherapy versus sequential radiotherapy on the basis of immunochemotherapy among patients with oligometastatic ESCC, so as to fill the evidence gap in existing research.",[26],"Esophageal Squamous Cell Carcinoma (ESCC)",[28,29,30,31],"Esophageal Squamous Cell Carcinoma","Anti-PD-1","Oligometastatis","Radiotherapy","RECRUITING","2026-07-09",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":21},"2026-07-15",{"date":40,"type":21},"2031-07-15",{"name":42,"class":43},"Fudan University","OTHER",1,{"id":46,"slug":4,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":54,"studyType":23,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100054103","NCT07697898","TDLN-Guided Lymphadenectomy After Neoadjuvant Immunochemotherapy for ESCC","Tumor-Draining Lymph Node Preservation-Guided Intraoperative Lymphadenectomy After Neoadjuvant Immunochemotherapy for Esophageal Squamous Cell Carcinoma: A Prospective Multicenter Observational Cohort Study","Inclusion Criteria:\n\n* Age 18 to 75 years, regardless of sex.\n* Eastern Cooperative Oncology Group performance status of 0 to 1.\n* Histologically confirmed thoracic esophageal squamous cell carcinoma.\n* Received neoadjuvant immunochemotherapy and considered suitable for curative surgery after multidisciplinary team evaluation.\n* Clinically resectable locally advanced or locally progressive disease without evidence of distant metastasis.\n* Completed preoperative contrast-enhanced computed tomography of the neck, chest, and abdomen. Positron emission tomography-computed tomography and\u002For endoscopic ultrasound may be performed if clinically available.\n* Considered by the investigator to be able to tolerate curative esophagectomy and standard systematic lymphadenectomy.\n\nExclusion Criteria:\n\n* Non-squamous cell carcinoma histology or concurrent primary malignancy requiring treatment.\n* Previous curative surgery for esophageal cancer or previous radiotherapy for the current esophageal lesion.\n* Evidence of distant metastasis, unresectable disease, or considered unsuitable for curative surgery after multidisciplinary team evaluation.\n* Severe autoimmune disease requiring long-term systemic immunosuppressive therapy.\n* Severe cardiac, pulmonary, hepatic, renal, or other major organ dysfunction that prevents surgery or completion of study-related assessments.\n* Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study, including poor compliance, inability to complete scheduled follow-up, or inability to provide key study data.","75 Years",{"count":53,"type":21},400,"24 Months","This is a prospective, multicenter, observational cohort study of patients with esophageal squamous cell carcinoma who have received neoadjuvant immunochemotherapy and are scheduled to undergo curative esophagectomy with standard systematic lymphadenectomy.\n\nThe study will not alter the current standard surgical approach. All patients will receive curative esophagectomy and systematic lymph node dissection according to institutional practice. Lymph nodes will be separated and recorded by anatomical station during surgery, followed by station-level pathological assessment. Imaging findings, pathological response, perioperative outcomes, recurrence patterns, disease-free survival, overall survival, and selected immune microenvironment features will be collected and analyzed.\n\nThe purpose of this study is to characterize station-level residual lymph node metastasis risk and immune activity after neoadjuvant immunochemotherapy. The findings may help identify candidate lymph node stations for future research on individualized or lymph node-preserving surgical strategies in esophageal squamous cell carcinoma.",[26],"NOT_YET_RECRUITING","2026-07-07",{"date":35,"type":36},{"date":61,"type":21},"2026-07-01",{"date":63,"type":21},"2031-06-30",{"name":65,"class":43},"Tongji Hospital",{"id":67,"slug":4,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":72,"targetDuration":4,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":79,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":44},"100645114","NCT07678580","Neoadjuvant Short-Course Radiotherapy Plus Tislelizumab and Chemotherapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma","Neoadjuvant Short-Course Radiotherapy Followed by Tislelizumab Combined With Chemotherapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma: A Prospective, Multicenter, Exploratory Study","Inclusion Criteria:\n\n* Voluntarily provided written informed consent prior to any study-related procedures\n* Aged 18 to 75 years, male or female\n* Life expectancy of at least 3 months\n* Predicted to achieve R0 surgical resection\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Histologically confirmed, treatment-naive, resectable locally advanced thoracic esophageal squamous cell carcinoma (ESCC) meeting the staging criteria: T1 N1-3 M0 or T2-4a N0-3 M0 (T2 ≥3 cm or poorly differentiated). No suspected metastatic cervical lymph nodes (except for upper thoracic esophageal cancer regional lymph nodes) on neck ultrasound or contrast-enhanced CT, and no distant metastasis on imaging\n* Presence of measurable tumor lesions.\n* Adequate organ function defined by laboratory parameters: Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; platelet count ≥100×10⁹\u002FL; hemoglobin ≥90 g\u002FL. Total bilirubin ≤1.5×ULN; AST and ALT ≤2.5×ULN. Serum creatinine ≤1.5×ULN or calculated creatinine clearance ≥60 mL\u002Fmin. INR ≤1.5, PT and APTT ≤1.5×ULN\n* Men and women of childbearing potential must use effective contraception during treatment and for 6 months after the last dose of study treatment\n* Good compliance and ability to complete scheduled follow-up.\n\nExclusion Criteria:\n\n* Prior treatment with PD-1\u002FPD-L1 inhibitors or other immunomodulatory agents targeting T-cell receptors (e.g., CTLA-4, OX40)\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage\n* Active or suspected autoimmune disease, including systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, except type 1 diabetes controlled by replacement therapy, hypothyroidism, or skin disorders not requiring systemic therapy\n* History of grade ≥2 interstitial lung disease\n* Systemic corticosteroids (\\>10 mg prednisone daily or equivalent) or other immunosuppressive agents within 14 days before first study treatment\n* Primary or acquired immunodeficiency, organ transplantation, allogeneic hematopoietic stem cell transplantation\n* Live vaccine within 4 weeks before first study treatment\n* Severe uncontrolled cardiovascular or cerebrovascular disease: Uncontrolled hypertension or pulmonary hypertension. Unstable angina, myocardial infarction, coronary artery bypass grafting, or stent implantation within 6 months. NYHA class ≥2 chronic heart failure. Left ventricular ejection fraction (LVEF) \\\u003C50%.\n\nClinically significant arrhythmia requiring treatment. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months. Uncontrolled active infection requiring systemic antibiotics. Positive HIV test, active hepatitis B or hepatitis C infection (exceptions: HBV DNA \\\u003C500 IU\u002FmL; HCV RNA undetectable).\n\nActive pulmonary tuberculosis (TB). Other active malignancy within the previous 2 years, except adequately treated thyroid cancer, carcinoma in situ of the cervix, basal\u002Fsquamous cell skin cancer, or ductal carcinoma in situ of the breast\n\n* History of drug abuse or psychiatric disorder\n* Pregnant or lactating women\n* Any other severe medical, psychiatric, or laboratory abnormality that, in the investigator's opinion, would increase study-related risk or interfere with result interpretation.",{"count":73,"type":21},50,"INTERVENTIONAL",[76],"PHASE2","Neoadjuvant Short-Course Radiotherapy Followed by Tislelizumab Plus Chemotherapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma This is a prospective, randomized, two-arm, parallel-group, multicenter, exploratory Phase II clinical trial. It aims to evaluate the efficacy and safety of neoadjuvant short-course radiotherapy followed by tislelizumab combined with chemotherapy in participants with locally advanced resectable esophageal squamous cell carcinoma (ESCC).\n\nEligible participants will be randomized in a 1:1 ratio to receive either low-dose or high-dose short-course radiotherapy, followed by tislelizumab, nab-paclitaxel, and carboplatin for 3 cycles. Surgery will be performed 4-6 weeks after the last neoadjuvant treatment.\n\nPrimary endpoint: Pathological Complete Response (pCR) rate. Secondary endpoints: Major Pathological Response (MPR) rate, Objective Response Rate (ORR), R0 resection rate, downstaging rate, 3-year Event-Free Survival (EFS), 3-year Overall Survival (OS), safety profile, and quality of life.\n\nApproximately 50 participants will be enrolled. Randomization will be stratified by tumor location, clinical T stage, and clinical N stage using a stratified block design via an EDC\u002FIWRS system.",[26],[28,80,81,82],"Neoadjuvant Therapy","Short-Course Radiotherapy","PD-1 Inhibitor","2026-06-28",{"date":61,"type":36},{"date":86,"type":21},"2026-07-10",{"date":88,"type":21},"2029-06-30",{"name":90,"class":43},"Tang-Du Hospital",{"id":92,"slug":4,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":98,"targetDuration":4,"studyType":74,"phases":100,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":44},"100619043","NCT07339488","Intestinal Low-Dose Radiotherapy Plus Immunochemotherapy for Conversion of Borderline Resectable\u002FUnresectable Esophageal Squamous Cell Carcinoma","Efficacy and Safety of Combining Intestinal Low Dose Radiotherapy Plus Tislelizumab and Chemotherapy for Conversion of Borderline Resectable\u002FUnresectable Esophageal Squamous Cell Carcinoma","ILDR-03","Inclusion Criteria:\n\n1. Patients voluntarily enroll in this study, sign an informed consent form, and demonstrate good compliance.\n2. Age ≥18 years and ≤75 years; both sexes are eligible.\n3. ECOG performance status score of 0-1.\n4. Pathologically confirmed esophageal squamous cell carcinoma (ESCC) prior to surgery.\n5. Thoracic esophageal cancer.\n6. Unresectable lesions, defined as: T4 stage; marginally resectable T3 stage (invading other organs, e.g., trachea, bronchus, or aorta not ruled out by imaging); presence or absence of unresectable lymph nodes or metastatic lymph nodes invading adjacent organs; presence or absence of supraclavicular lymph node metastasis; or clinically confirmed unresectable disease by the surgeon.\n7. No prior history of anti-tumor treatment, including chemotherapy, hormonal therapy, radiotherapy, or immunotherapy.\n8. Baseline laboratory requirements (within 7 days prior to enrollment):\n\n   Hematology:\n   1. Hb≥90 g\u002FL (no transfusion within 14 days)\n   2. NEUT ≥1.5×10⁹\u002FL\n   3. PLT ≥100×10⁹\u002FL\n   4. WBC≥3×10⁹\u002FL\n\n   Biochemistry:\n   1. ALT and AST≤2.5×ULN\n   2. TBIL≤1.5×ULN\n   3. SCr≤1.5×ULN; or CrCl≥60 mL\u002Fmin Coagulation: APTT, INR, and PT≤1.5×ULN Thyroid function: TSH≤ULN (if abnormal, FT3\u002FFT4 levels should also be considered; eligible if FT3\u002FFT4 are normal) Echocardiography: LVEF≥50%\n9. Female subjects need to agree to use contraception during the study and for 6 months post-study; serum pregnancy test negative within 7 days prior to enrollment; non-lactating. Male subjects must agree to use contraception during the study and for 6 months post-study.\n10. No psychological, familial, social, or geographical factors that may impair protocol adherence.\n11. Other parameters meet general clinical trial enrollment criteria.\n12. The subject or authorized representative has read, fully understands the patient information sheet, and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with distant metastases other than supraclavicular lymph node metastases.\n2. Presence or high risk of esophageal perforation.\n3. Patients with contraindications to radiotherapy or immune checkpoint inhibitor (ICI) therapy.\n4. Patients who previously experienced unacceptable toxicity after receiving ICI therapy.\n5. Patients with a history of thoracoabdominal\u002Fpelvic radiotherapy within 6 months prior to enrollment.\n6. Adverse reactions from prior anti-tumor treatment have not recovered to CTCAE v5.0 grade≤1 (excluding toxicities deemed by the investigator to pose no safety risk, such as fatigue or alopecia).\n7. Subjects with active, uncontrolled systemic bacterial, viral, or fungal infections despite optimal treatment.\n8. Respiratory depression, airway obstruction, or tissue hypoxia.\n9. Severe cardiac disease (i.e., NYHA functional class II or higher).\n10. Markedly abnormal liver or kidney function (i.e., indicators \\>3 times the upper limit of normal).\n11. Active hepatitis B, hepatitis C, HIV, or syphilis.\n12. Active brain disease or central nervous system\u002Fmeningeal metastases with significant symptoms, or impaired decision-making capacity.\n13. Hypersensitivity to drugs included in the trial.\n14. Drug and\u002For alcohol abuse.\n15. Pregnant or lactating women.\n16. Concurrent participation in another therapeutic clinical trial.\n17. Major surgical procedure within 30 days prior to enrollment.\n18. Use of antibiotics, antifungals, antivirals, or antiparasitics within 4 weeks prior to registration.",{"count":99,"type":21},43,[76],"Esophageal cancer (EC) ranks among the leading malignant gastrointestinal tumors globally in terms of both incidence and mortality. Cases of EC in China account for over 50% of the global total, with squamous cell carcinoma being the primary pathological type. Locally advanced EC (LAEC), particularly cases where radical surgical resection is not feasible, exhibits high recurrence rates and low 5-year survival rates. However, studies have shown that patients with LAEC who undergo comprehensive treatment followed by surgery experience significantly prolonged survival and improved quality of life compared to those who do not receive surgical intervention.\n\nCurrent conversion treatment regimens under investigation include: chemotherapy alone, chemoradiotherapy, immunotherapy combined with chemotherapy, and immunotherapy combined with chemoradiotherapy-each of these approaches has distinct advantages and limitations. Immunochemotherapy has emerged as a current research focus: it not only demonstrates significantly superior efficacy compared to chemotherapy alone but also exhibits lower cumulative toxicity than radiotherapy-combined conversion regimens, resulting in a more favorable overall benefit-risk ratio. As such, it represents the most promising conversion treatment strategy.\n\nRetrospective and prospective clinical studies have shown that low-dose radiotherapy targeting the small intestine can enhance the anti-tumor response of immune checkpoint inhibitors (ICIs) in patients with advanced solid tumor, prolong their overall survival, and increase the incidence of the abscopal effect. Further mechanistic investigations have revealed that intestinal low-dose radiotherapy (ILDR) may augment the immune cancerous lethality by modulating the gut microbiota and their metabolic profiles.\n\nBased on the findings from these preliminary studies, the current research plans to conduct a prospective phase II single-arm clinical trial to investigate the efficacy and safety of ILDR combined with immunochemotherapy as conversion therapy in patients with borderline resectable or unresectable esophageal squamous cell carcinoma (BR\u002FUR ESCC). This research plans to enroll at least 39 evaluable cases or a total of 43 cases in two seperated stages, focusing on patients with thoracic BR\u002FUR ESCC. Patients will receive a single fraction of ILDR with a mean dose of 1 Gy, concurrently with 3 cycles of albumin-bound paclitaxel (260 mg\u002Fm² on day 1), cisplatin (75 mg\u002Fm² on day 1), and tislelizumab (200 mg on day 1). The efficacy and safety of the treatment will be evaluated throughout the study.",[103,104,26,105,106,31,107],"Borderline Resectable Carcinoma","Unresectable Cancer","Immune Checkpoint Inhibitor","Chemotherapy","Tislelizumab","2026-06-17",{"date":110,"type":36},"2026-06-18",{"date":112,"type":36},"2025-12-05",{"date":114,"type":21},"2028-11-01",{"name":116,"class":43},"Chuangzhen Chen",{"id":118,"slug":4,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":124,"targetDuration":4,"studyType":74,"phases":126,"briefSummary":127,"conditions":128,"keywords":129,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":139,"leadSponsor":141,"locationsCount":44},"100643252","NCT07638436","Adebrelimab Combined With Neoadjuvant Chemotherapy in Borderline Resectable Locally Advanced Esophageal Squamous Cell Carcinoma","Phase II Trial of Adebrelimab Combined With Nab-paclitaxel and Carboplatin for Neoadjuvant Therapy in Patients With Borderline Resectable Locally Advanced Esophageal Squamous Cell Carcinoma","NEOCRTEC2501","Inclusion Criteria:1.Voluntarily participate in the study and sign the written informed consent form.\n\n2.Aged between 18 and 75 years old. 3.Histologically confirmed thoracic esophageal squamous cell carcinoma without distant metastasis. Patients are defined as borderline resectable after enhanced computed tomography (CT), and\u002For endoscopic ultrasonography (EUS), endobronchial ultrasonography (EBUS) and multidisciplinary team (MDT) discussion.\n\n4.No prior chemotherapy or radiotherapy. 5.Estimated overall survival of no less than 3 months. 6.Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.\n\n7.Hematological parameters (tested within 7 days): Hemoglobin (Hb) ≥ 90 g\u002FL; Neutrophil count (NE) ≥ 1.5×10⁹\u002FL; Platelet count (PLT) ≥ 100×10⁹\u002FL.\n\n8.Hepatic and renal function (tested within 7 days): Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Creatinine ≤ 1.5 × ULN; Aspartate transaminase (AST)\u002FAlanine transaminase (ALT) ≤ 2.5 × ULN; Alkaline phosphatase (ALP) ≤ 5.0 × ULN.\n\n9.Absence of severe complications, including active massive gastrointestinal bleeding, perforation, jaundice, intestinal obstruction, and non-neoplastic fever above 38°C.\n\n10.Fertile patients must adopt effective contraceptive measures throughout the study period.\n\n11.Good treatment compliance, and able to complete follow-up assessments for efficacy and adverse events as required by the protocol.\n\nExclusion Criteria:\n\n1. Patients with cervical esophageal squamous cell carcinoma.\n2. Patients with distant metastasis.\n3. Patients with nearly complete esophageal obstruction confirmed by endoscopy who require interventional therapy for decompression.\n4. Patients with prior placement of esophageal or tracheal stents.\n5. Patients with high risk of bleeding or perforation due to obvious tumor invasion into adjacent vital organs (major arteries or trachea), or patients with existing fistula formation.\n6. Patients with other concurrent primary malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).\n7. Use of immunosuppressive drugs within 1 week prior to enrollment. This exclusion does not apply to intranasal, inhaled or other topical glucocorticoids, systemic glucocorticoids at physiological doses (i.e., prednisone ≤ 10 mg\u002Fday or equivalent), or glucocorticoids administered for contrast medium allergy prophylaxis.\n8. Active autoimmune diseases requiring symptomatic treatment, or a medical history of such diseases within the past 2 years.\n9. Known history of primary immunodeficiency.\n10. Confirmed active tuberculosis.\n11. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n12. Interstitial lung disease requiring corticosteroid therapy. 13Known allergy to any monoclonal antibody, chemotherapeutic agents (taxanes, carboplatin), or their excipients.\n\n14.Severe cardiac diseases, including documented congestive heart failure, uncontrolled high-risk arrhythmia, medically treated angina pectoris, clinically significant valvular heart disease, history of severe myocardial infarction, and refractory hypertension.\n\n15.Chronic diarrhea (≥4 watery stools per day) or renal insufficiency. 16.Active infection or active communicable diseases. 17.Neurological or psychiatric disorders impairing cognitive function. 18.Pregnant or breastfeeding women. 19.Other acute or chronic diseases, psychiatric disorders or abnormal laboratory findings that, in the investigator's judgment, may increase risks related to study participation or study drug administration, or interfere with the interpretation of study results.",{"count":125,"type":21},42,[76],"This clinical trial aims to preliminarily evaluate the efficacy and safety of adebrelimab combined with albumin-bound paclitaxel and carboplatin as neoadjuvant therapy for borderline resectable locally advanced esophageal squamous cell carcinoma (ESCC). The primary research objectives are to increase the R0 resection rate in such patients, thereby reducing the recurrence rate and improving overall survival (OS), as well as avoiding adverse reactions associated with radiotherapy.",[26],[130,131,132,133,134],"Adebrelimab","chemotherapy","neoadjuvent","immune checkpoint inhibitor","borderline resectable","2026-06-04",{"date":137,"type":36},"2026-06-10",{"date":108,"type":21},{"date":140,"type":21},"2028-01-31",{"name":142,"class":43},"Sun Yat-sen University",{"id":144,"slug":4,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":74,"phases":151,"briefSummary":153,"conditions":154,"keywords":155,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":4},"100637133","NCT07621601","A Study of HS-20093 in Patients With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)","A Multicenter, Randomized, Open-Label, Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HS-20093- Injection Versus Investigator's Choice of Chemotherapy in Patients With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Progress of First-Line Standard Therapy","Inclusion Criteria:\n\n1. Age ≥18 years at the time of informed consent form (ICF) signature, either sex.\n2. Be willing to participate in this clinical trial with understanding of study procedures, ability to provide written informed consent, and commitment to comply with all requirements specified in this clinical trial protocol.\n3. Patients with histologically or cytologically confirmed diagnosis of advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC), progressed after receiving first-line standard treatment.\n4. Presence of at least one target lesion according to RECIST v1.1.\n5. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1.\n6. Minimum life expectancy \\>12 weeks.\n7. Adequate organ function.\n8. Absence of the following active infectious diseases: hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, tuberculosis, or syphilis.\n9. Female patients with negative serum pregnancy test result within 7 days prior to first dose administration, or documentation of no pregnancy risk.\n\nExclusion Criteria:\n\n* 1\\. Prior pathological diagnosis of esophageal adenocarcinoma, esophageal adenoid cystic carcinoma, esophageal mucoepidermoid carcinoma, esophageal undifferentiated carcinoma, esophageal neuroendocrine carcinoma, or esophageal mixed carcinoma 2. Prior or ongoing treatment with any of the following:\n\n  1. Prior or current treatment targeting B7-H3;\n  2. Prior or current treatment with topoisomerase I inhibitor agents, including antibody-drug conjugates with topoisomerase I inhibitor payloads, etc.; 3. Persistent adverse reactions caused by prior treatment. 4. Untreated brain metastases; uncontrolled brain metastases; presence of leptomeningeal or brainstem metastases; presence of spinal cord compression.\n\n     5\\. History of other primary malignancies. 6. Severe, uncontrolled, or active cardiovascular or cerebrovascular disease. 7. Severe or poorly controlled hypertension and diabetes mellitus. 8. Tumors have the risk of leading perforation\u002Ffistula, hemorrhage, or obstruction.\n\n     9\\. Known or suspected interstitial pneumonitis, immune-mediated pneumonitis, or radiation pneumonitis.\n\n     10\\. Known to have allergic reactions or contraindications to the investigational medicinal product.",{"count":150,"type":21},494,[152],"PHASE3","This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093- injection versus investigator's choice of chemotherapy in patients with locally advanced or metastatic esophageal squamous cell carcinoma after progress of first-line standard therapy.",[26],[156,157,158,159],"ESCC","HS-20093","advanced","metastatic","2026-05-26",{"date":162,"type":36},"2026-06-02",{"date":164,"type":21},"2026-07-31",{"date":166,"type":21},"2032-12-31",{"name":168,"class":169},"Hansoh BioMedical R&D Company","INDUSTRY",{"id":171,"slug":4,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":17,"minAge":177,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":74,"phases":180,"briefSummary":181,"conditions":182,"keywords":183,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":199},"100608759","NCT07205731","Phase II Study Evaluating Safety and Efficacy of Tislelizumab for Elderly Patients Unfit for Chemotherapy, With Advanced Esophageal Squamous-cell Carcinoma","PRODIGE 102 - FFCD 2201 - SAFE-ESO Phase II Study Evaluating Safety and Efficacy of Tislelizumab for Elderly Patients Unfit for Chemotherapy, With Advanced Esophageal Squamous-cell Carcinoma","SAFE ESO","Inclusion Criteria:\n\n* Histologically proven esophageal squamous cell carcinoma (ESCC)\n* Metastatic or locally advanced cancer\n* Absence of previous treatment (immunotherapy, chemotherapy or radiotherapy) in first line setting\n* Ineligibility for a platinum-based chemotherapy assessed by oncologist and geriatrician\n* At least one evaluable and\u002For measurable lesion as defined by RECIST v1.1 criteria\n* Patients ≥ 70 years\n* Subjects with WHO performance status ≤ 2\n* Estimated life expectancy \\>3 months\n* Adjuvant therapy finished \\>6 months\n* Adequate marrow and organ functions defined as:\n\n  * Absolute neutrophil count (ANC) ≥ 1 × 109\u002FL,\n  * Platelet count ≥ 75 × 109\u002FL,\n  * Hemoglobin ≥ 90 g\u002FL,\n  * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 × ULN, or AST and ALT ≤5 ×ULN for patients with liver metastases\n  * ALP ≤ 5 x ULN unless liver metastases are present, in which case it must be ≤ 10x ULN\n  * Measured creatinine clearance (CL) \\> 40 mL\u002Fmin (MDRD method)\n* Male patients must use a condom during treatment and for 6 months after the last dose when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential during treatment and for 6 months after the last dose.\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits and examinations including follow up.\n* Signed written informed consent obtained prior to any study specific procedures\n* Patient affiliated to a social security scheme\n\nExclusion Criteria:\n\n* History of another primary malignancy. May be included, patients with:\n\n  * Malignancy treated with curative intent and with no known active disease ≥ 2 years before the first dose of treatment\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n  * Adequately treated carcinoma in situ without evidence of disease\n* Locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy per local investigator\n* Participation in another clinical study with an investigational product during the last 2 months.\n* Concurrent enrolment in another clinical study unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n* History of allogenic organ, bone marrow, or double umbilical cord blood transplantation\n* Active documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). May be included:\n\n  * Patients with vitiligo or alopecia\n  * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.\n  * Any chronic skin condition that does not require systemic therapy.\n  * Patients with celiac disease controlled by diet alone\n* Previous immune checkpoint inhibitor therapy within the 2 years before inclusion\n* Uncontrolled intercurrent illness; uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention (recurrence ≤ 14 days after intervention). Patients with the following diseases are not excluded and may proceed to further screening:\n\n  * Controlled Type I diabetes\n  * Hypothyroidism (provided it is managed with hormone replacement therapy only)\n  * Controlled celiac disease\n  * Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia)\n  * Any other disease that is not expected to recur in the absence of external triggering factors\n* Patients with evidence of fistula (either oesophageal\u002Fbronchial or oesophageal\u002Faorta)\n* Patients considered at poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled ventricular arrhythmia, recent (within 6 months) myocardial infarction, pulmonary embolism\u002Fdeep vein thrombosis, cerebrovascular accident, and heart failure, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, interstitial bilateral lung disease on high Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent. Underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse or dependence that will be unfavorable for the administration of study drug or affect the explanation of drug toxicity or AEs or might impair compliance with study conduct. A history of severe hypersensitivity reactions to other monoclonal antibodies. Has received any chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin, etc) or any investigational therapies within 14 days or 5 half-lives (whichever is shorter) of the first study drug administration.\n* Patients with myelodysplastic syndrome\u002Facute myeloid leukaemia or with features suggestive of MDS\u002FAML.\n* Patient with symptomatic central nervous system (CNS) metastases.\n* History of active primary immunodeficiency.\n* Known non-controlled serologically positive human immunodeficiency virus (HIV) patients with CD4 \\\u003C 400 \u002F mm3.\n* Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), active untreated hepatitis B (known positive HBV surface antigen (HBsAg) result), active untreated hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of -immunotherapy. The following are exceptions to this criterion:\n\n  * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n  * Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n  * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of ICI\n* Follow-up impossible, according to investigator's decision\n* Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol or follow-up schedule\n* Persons i) deprived of liberty by judicial or administrative decision, persons subject to psychiatric care under Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8 and persons admitted to a health or social care facility for purposes other than research, and (ii) adults subject to a legal protection measure or unable to express their consent (Article L1121-8)","70 Years",{"count":179,"type":21},95,[76],"The goal of this clinical trial is to assess the percentage of patients alive at 6 months in elderly patients, not eligible to an platinum-based chemotherapy, but who can received the Tislelizumab treatment alone as first-line treatment for an advanced esophageal squamous-cell carcinoma (ESCC).\n\nTislelizumab is a monoclonal antibody administred by intravenous infusion\n\nThis study aims to anwer too at the questions:\n\n* the Safety of the drug\n* Overall survival (OS) at 6 months according the diagnostic of PD-L1 expression (PD-L1 is a protein present on the surface of immune cells)\n* Overall response rate (ORR) according to imagery criteria\n* Progression-free survival (PFS) at 3 and 6 months according to imagery criteria and depending on PDL1 expression\n* Patients' health-related quality of life\n* OS and PFS according to geriatric parameters\n* Prognostic value of immune biomarkers",[26],[184,185,186,187,188,189,131],"digestive oncology","immunotherapy","microenvironment biomarker","oncology","oncogeriatric domain","Ederly patients","2026-05-18",{"date":192,"type":36},"2026-05-20",{"date":194,"type":36},"2025-10-07",{"date":196,"type":21},"2030-10",{"name":198,"class":43},"University Hospital, Clermont-Ferrand",30,{"id":201,"slug":4,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":207,"targetDuration":4,"studyType":74,"phases":209,"briefSummary":210,"conditions":211,"keywords":212,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":44},"100640771","NCT07595770","Adebrelimab Combined With Neoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma","A Study on the Safety and Efficacy of Adalimumab Combined With Chemoradiotherapy as Neoadjuvant Therapy for Esophageal Squamous Cell Carcinoma","ANCRE","Inclusion Criteria:\n\n* \\- 1. Provided informed consent and sign the informed consent form;\n* 2\\. Male or female, Aged 18-75 years (counted on the date of signing informed consent);\n* 3\\. Pathological confirmed ESCC;\n* 4\\. Patients assessed by thoracic oncologists as resectable without distant metastasis\n* 5\\. Patients evaluate with clinical staging of T1-4aN1-3M0 or T3-4aN0M0(AJCC 9.0) based on imaging and pathological examination results;\n* 6\\. Have at least one assessable lesion according to the RECIST V1.1\n* 7\\. ECOG-PS score: 0-1;\n* 8\\. Patients with normal function of organs such as heart, brain, lungs, and kidneys who can tolerate surgery;\n* 9\\. With a life expectancy of ≥ 6 weeks;\n* 10\\. Adequate major organ function without severe hematologic, cardiac, pulmonary, hepatic, renal, or bone marrow dysfunction, and no immunodeficiency disease;\n\nExclusion Criteria:\n\n* 1\\. Patients who have received or are currently receiving chemotherapy, radiotherapy, immunotherapy, or targeted therapy\n* 2\\. Patients with distant metastasis or inability to undergo resection after evaluation by thoracic surgeons\n* 3\\. Simultaneously developing tumors in other parts of the body\n* 4\\. Severe impairment of heart, liver, and kidney function (heart function grade 3-4, ALT and\u002For AST exceeding the upper limit of normal by more than 1.5 times, Cr (serum creatinine) exceeding the upper limit of normal by more than 1.5 times)\n* 5\\. Patients with a history of autoimmune diseases who were receiving immunosuppressive therapy prior to enrollment, with immunosuppressive doses\\>10 mg\u002Fday or oral prednisone for more than 2 weeks\n* 6\\. Severe allergy to immune preparations\n* 7\\. Abnormal coagulation function: (PT\\>16s, APTT\\>53s, TT\\>21s, Fib\\\u003C1.5 g\u002FL), bleeding tendency or during thrombolytic or anticoagulant therapy\n* 8\\. Pregnancy or lactation period\n* 9\\. Other situations as judged by investigators not suitable for inclusion.;",{"count":208,"type":21},37,[76],"This study aims to systematically evaluate the safety and efficacy of adalimumab combined with paclitaxel, carboplatin, and short-course radiotherapy in the neoadjuvant treatment of esophageal squamous cell carcinoma.",[26],[131,213,214,215],"radiotherapy","immune checkpoint inhibitors","adebrelimab","2026-05-13",{"date":218,"type":36},"2026-05-19",{"date":220,"type":21},"2026-05-22",{"date":222,"type":21},"2029-10-01",{"name":224,"class":43},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":226,"slug":4,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":74,"phases":233,"briefSummary":235,"conditions":236,"keywords":242,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":262},"100599484","NCT07085091","A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors","A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants With Advanced or Metastatic Select Solid Tumors","Inclusion Criteria:\n\n* Participants with locally advanced, recurrent or metastatic histologically confirmed HNSCC, NSCLC, ESCC, CRC; locally advanced or recurrent disease must not be amenable to resection with curative intent\n\n  1. Dose Escalation: Participants who have relapsed or progressed following prior anticancer therapy in the advanced\u002Fmetastatic setting and for whom no approved or standard therapy is available.\n  2. Dose Exploration and Dose Expansion: The following tumor-specific criteria also apply. These cohorts will include all or a subset of these tumors.\n\nHNSCC - Received no more than 3 prior lines of therapy in the advanced or metastatic setting\n\nNSCLC - For participants with a targetable molecular alteration: received appropriate standard targeted therapy and no more than 2 prior lines of systemic chemotherapy in the advanced\u002Fmetastatic setting. For participants without a targetable molecular alteration: received platinum-based chemotherapy and CPI (in combination or separately), and have received no more than 2 prior lines of systemic chemotherapy in the advanced\u002Fmetastatic setting\n\nESCC - Received no more than 3 prior lines of therapy in the advanced\u002Fmetastatic setting\n\nCRC - For participants with a targetable molecular alteration (including dMMR or MSI-H): Received appropriate standard therapy for the alteration, at least 2 prior lines of systemic chemotherapy, and no more than 4 prior lines of therapy in the advanced\u002Fmetastatic setting. For participants without a targetable molecule alteration: Received at least 2 prior lines of systemic chemotherapy (including an oxaliplatin-based chemotherapy), vascular endothelial growth factor (VEGF)-based therapy, and no more than 4 prior lines of therapy in the advanced\u002Fmetastatic setting.\n\n* Adequate Bone Marrow Function\n* Adequate Renal \\& Liver Function\n* Adequate Performance Status\n\nExclusion Criteria:\n\n* Participants with disease suitable for local therapy with curative intent.\n* Has a life expectancy of less than 3 months and\u002For has rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator\n* Prior treatment with any ADCs that have an active TOP1 inhibitor-based component",{"count":232,"type":21},170,[234],"PHASE1","A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants with Advanced or Metastatic Select Solid Tumors",[237,238,239,156,240,241,26],"NSCLC (Advanced Non-small Cell Lung Cancer)","HNSCC","CRC (Colorectal Cancer)","Colo-rectal Cancer","Head and Neck Cancer",[243,244,245,159,246,247,238,248,249,250,251,252],"ALX2004","EGFR","Solid Tumors","Antibody Drug Conjugate","ADC","CRC","Lung","Non small cell lung cancer","esophageal","EGFR ADC","2026-05-11",{"date":255,"type":36},"2026-05-12",{"date":257,"type":36},"2025-08-18",{"date":259,"type":21},"2027-12",{"name":261,"class":169},"ALX Oncology Inc.",8,{"id":264,"slug":4,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":269,"targetDuration":4,"studyType":74,"phases":271,"briefSummary":272,"conditions":273,"keywords":274,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":44},"100635927","NCT07559045","Induction Chemo-Immunotherapy + Radiotherapy vs Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma","Efficacy and Safety of Induction Chemo-Immunotherapy Followed by Radiotherapy vs Concurrent Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Randomized, Two-Arm, Phase II Study","Inclusion Criteria:\n\n* Histologically or cytologically confirmed unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Adequate organ function (bone marrow, liver, renal, cardiac) within 2 weeks prior to randomization\n* Measurable or evaluable disease per RECIST 1.1\n* Willing to provide written informed consent\n\nExclusion Criteria:\n\n* Previous radiotherapy to the chest or previous systemic chemotherapy for ESCC\n* History of other malignancies within the last 5 years (except cured basal cell carcinoma or cervical carcinoma in situ)\n* Severe comorbidities (uncontrolled hypertension, NYHA class III-IV heart failure, active infection, etc.)\n* Known hypersensitivity to any study drugs (paclitaxel, cisplatin\u002Fcarboplatin, PD-1 antibody)\n* Pregnant or lactating women\n* Participation in another clinical trial within 30 days prior to randomization",{"count":270,"type":21},92,[76],"This is a prospective, randomized, phase II clinical study in patients with unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC). Eligible patients will be randomly assigned in a 1:1 ratio to two treatment groups. The experimental group will receive 3 cycles of induction therapy with PD-1 antibody plus chemotherapy, followed by radiotherapy, and then maintenance therapy with PD-1 antibody monotherapy. The control group will receive concurrent chemoradiotherapy, followed by maintenance therapy with PD-1 antibody monotherapy. The primary endpoints are the complete response (CR) rate at 3 months after radiotherapy (assessed by investigators) and the 1-year progression-free survival (PFS) rate. Secondary endpoints include overall survival (OS), progression-free survival (PFS), duration of response, objective response rate (ORR), local-regional recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), quality of life, and safety profile.",[26],[28,275,276,277,82],"Chemo-Immunotherapy","Induction Therapy","Concurrent Chemoradiotherapy","2026-04-26",{"date":280,"type":36},"2026-04-30",{"date":282,"type":36},"2026-01-01",{"date":284,"type":21},"2028-06-30",{"name":286,"class":43},"Second Affiliated Hospital of Zunyi Medical University",{"id":288,"slug":4,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":74,"phases":295,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":44},"100628587","NCT07463573","QLC5508 vs. Chemotherapy in Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma","A Randomized, Open-Label, Multicenter Phase III Study of QLC5508 Versus Investigator's Choice Chemotherapy in Pretreated Participants With Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)","Inclusion Criteria:\n\n* Voluntarily consent to participate in this study and sign the informed consent form.\n* Males and females aged ≥18 years old;\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 within 7 days before the first dose;\n* Estimated survival time of more than 3 months.\n* A serum pregnancy test must be performed within 7 days prior to randomization for premenopausal women of childbearing potential, and the result must be negative and must not be lactating;\n* All enrolled patients and the partners should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.\n* Capable of understanding trial requirements, willing and able to comply with trial and follow-up procedures.\n* Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0 (v6.0);\n* Has histologically or cytologically documented unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) according to American Joint Committee on Cancer 8th edition staging system on ESCC.\n\n  * Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) as assessed by the investigator.\n* Sufficient bone marrow and organ function.\n\nExclusion Criteria:\n\n* Diagnosis of other primary malignancies within 5 years prior to signing the informed consent form.\n* Having histologically or cytologically confirmed adenosquamous carcinoma subtype.\n* Brain metastases (unless asymptomatic and no progression confirmed by imaging ≥4 weeks prior to randomization);\n* Presence of leptomeningeal metastases or brainstem metastases;\n* Spinal cord compression (identified via imaging, regardless of symptoms);\n* Previous or ongoing treatment with topoisomerase I inhibitors\n* Having previously received B7-H3-targeted therapy.\n* Being ineligible to any chemotherapies in the control arm due to prior progression or intolerance.\n* Insufficient washout of prior anticancer therapies prior to randomization.\n* Having underwent major organ surgery (excluding biopsy) or significant trauma within 4 weeks prior to randomization;\n* Requiring elective surgery during the study.\n* Having received live vaccine or live attenuated vaccine within 4 weeks before study randomization.\n* Having received treatment with systemic corticosteroids (prednisone at \\>10 mg\u002Fday, or similar drugs at equivalent dose) or other immunosuppressive agents within 14 days prior to randomization;\n* Moderate to severe pulmonary disease significantly impairing lung function, including idiopathic pulmonary fibrosis, autoimmune\u002Fconnective tissue disorders with lung involvement, or prior pneumonectomy.\n* Having a history of interstitial lung disease (ILD)\u002F non-infectious pneumonitis that required corticosteroids, current ILD\u002F non-infectious pneumonitis, or suspected ILD\u002F non-infectious pneumonitis that cannot be ruled out by imaging at screening;\n* Active tuberculosis;\n* Autoimmune diseases not in clinical remission, other acquired or congenital immunodeficiency diseases,\n* A history of allogeneic stem cell, bone marrow, or organ transplantation.\n* Serious infections (e.g., bacteremia, or severe pneumonia) within 4 weeks prior to randomization;\n* active infection requiring systemic antibiotic therapy within 1 weeks prior to randomization;\n* Has positive results in virus serology tests (hepatitis B virus infection participants receiving antiviral treatment other than interferon are allowed to be enrolled);\n* Uncontrolled or significant cardiovascular disease.\n* Clinically uncontrolled third-space effusion.\n* Known hypersensitivity to investigational product components, analogues, or control drugs (e.g., docetaxel, paclitaxel, irinotecan hydrochloride).\n* Drug abuse;\n* Any other medical conditions that may interfere with study participation or the results of the clinical study as per the discretion of investigator;\n* Has alcohol or drug dependence.\n* Poor compliance as per investigator discretion;\n* Has a history of other serious systemic diseases.",{"count":294,"type":21},466,[152],"This study is designed to assess the efficacy and safety of QLC5508 in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have experienced disease progression following treatment with a platinum-based systemic therapy and an immune checkpoint inhibitor (ICI) compared with investigator's choice of chemotherapy (ICC).",[26],"2026-04-21",{"date":300,"type":36},"2026-04-24",{"date":302,"type":36},"2026-04-20",{"date":304,"type":21},"2029-07-05",{"name":306,"class":169},"Qilu Pharmaceutical Co., Ltd.",{"id":308,"slug":4,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":74,"phases":316,"briefSummary":317,"conditions":318,"keywords":328,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":352,"locationsCount":354},"100607539","NCT07189871","177Lu-BetaBart in Patients With Relapsed\u002FRefractory, Locally Advanced Inoperable, or Metastatic Solid Tumors","A Phase 1\u002F2a Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients With Relapsed\u002FRefractory, Locally Advanced Inoperable, or Metastatic Solid Tumors","BetaBart","Inclusion Criteria:\n\n1. Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.\n2. Participants ≥ 18 years of age.\n3. Participants with a documented history of histopathologically confirmed CRPC\\*, CRC, NSCLC, SCLC, HNSCC, ovarian cancer, cervical cancer, endometrial cancer, TNBC, or ESCC. (Note: inclusion or exclusion criteria below marked with \\* refer to CRPC only, criteria without \\* refer to all tumor indications including CRPC)\n\n   a. \\*Progressive CRPC defined as castrate levels of testosterone and progressing by at least one of the following criteria: i. Serum PSA progression consisting of two consecutive increases in PSA measured at least 1 week apart. The minimal baseline value is 2.0 ng\u002FmL.\n\n   ii. Soft tissue progression defined as a ≥20% increase in the sum of the diameter (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest sum of the diameter since the previous treatment was started or the appearance of one or more new lesions by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI).\n\n   iii. Progression of bone disease defined by Prostate Cancer Working Group 3 (PCWG3) as evaluable disease or new bone lesions by bone scan.\n\n   iv. Identification of new soft tissue or bone lesions on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging.\n\n   b. \\*Metastatic disease defined as either or both of the following: i. Documented M1 disease on conventional imaging (CT\u002FMRI of the chest\u002Fabdomen\u002Fpelvis and\u002For Technetium 99m \\[99mTc\\] whole-body bone scan) ii. Identification of bone lesion(s), extra-pelvic soft tissue lesion(s), or visceral metastases on PSMA PET imaging with an FDA-approved imaging agent (e.g., 68Ga-PSMA-11, 18F-DCFPyL, or 18F-rhPSMA-7.3) c. \\*Progression following treatment with ADT and at least one ARSI (e.g., enzalutamide, apalutamide, darolutamide, and\u002For abiraterone acetate). If a participant is currently on ADT, they should continue ADT for the duration of their participation in the study but will not be permitted to start a new therapy or ADT regimen. If a participant has progressed on an ARSI, they will have the option to remain on the same ARSI or discontinue therapy. If they discontinue the ARSI, a 28-day washout period will be required prior to initiating study intervention.\n\n   d. Prior definitive and palliative external beam radiation therapy and stereotactic body radiation therapy is allowed.\n\n   Note: Participants with extended external beam radiation therapy to the axial skeleton, which in the opinion of the Investigator may pose a risk for increased myelotoxicity, will be discussed with the Sponsor to determine eligibility.\n\n   e. Participants with liver metastases are eligible if they meet the following criteria: i. ≤3 lesions i. All lesions must be ≤2 cm in the short axis ii. SUVmean ≥2 x that of liver parenchyma f. \\*Prior treatment with one taxane-based chemotherapy is allowed but not required. A taxane-based chemotherapy is defined as a minimum exposure of two cycles of a taxane chemotherapy.\n4. Participants must have documented disease progression during or after their most recent line of anticancer therapy. Participants must be refractory to or intolerant of standard of care therapy or have no standard of care therapy available that is likely to provide clinical benefit. Any number of prior treatment lines are allowed.\n5. Must have at least 1 measurable target lesion according to RECIST v1.1. (Note: this does not apply for CRPC)\n6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n7. Participants must have a life expectancy of ≥ 4 months in the opinion of the Investigator.\n8. Participants of child-bearing potential (CBP) must have a negative β-hCG test and must not be breastfeeding. Participants of CBP are defined as those who are not surgically sterile or post-menopausal. Participants will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. Participants \\\u003C 50 years of age who meet the criteria for post-menopausal status without previous surgical sterilization should be considered for further investigation with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels to confirm serological post-menopausal status.\n9. Participants of CBP must agree to use a highly effective method of contraception during the study and for 6 months after the last dose of 177Lu-BetaBart, as described in Appendix 4.\n10. Male participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during the study and for 6 months after the last dose of 177Lu-BetaBart, as described in Appendix 4. All male participants must agree to not donate sperm during the study and for 6 months after the last dose of 177Lu-BetaBart.\n11. Participants who have received prior radiation therapy \\>28 days before the first dose of 177Lu-BetaBart are permitted. Documentation of the dates the radiotherapy was received, the cumulative dose, and the absorbed dose to critical organs, if available, should be provided.\n12. Participants with previously treated brain metastases are eligible to participate if:\n\n    * they are neurologically and radiologically stable (no evidence of progression by imaging; same imaging modality \\[MRI or CT scan\\] must be used for each assessment) for at least 28 days prior to the first dose of 177Lu-BetaBart; and\n    * do not require corticosteroids to treat associated neurological symptoms or if required, are on a stable dose of corticosteroids not exceeding 10 mg\u002Fday of prednisone (or equivalent), and\n    * have no history of leptomeningeal disease or spinal cord compression.\n\nExclusion Criteria:\n\n1. History of prior organ transplant.\n2. Any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer. Participants with a history of malignancies of low recurrence potential who have received curative-intent therapy may be approved on a case-by-case basis in discussion with the Sponsor, if it is determined not to put the participant at an increased risk of adverse drug effects and\u002For interfere with the integrity of the study outcome.\n3. Have any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures such as participants with severe claustrophobia who are unresponsive to oral anxiolytics, participants with low back pain who cannot lie comfortably on an imaging table, participants who are hyperactive or hyperkinetic such that they cannot tolerate lying still for multiple time point imaging procedures, etc.\n4. Residual toxicity ≥ Grade 2 from prior anti-cancer therapy (except alopecia and peripheral sensory neuropathy).\n5. History of uncontrolled allergic reactions and\u002For known or expected hypersensitivity to protein therapeutics, 177Lu-BetaBart, or any of its excipients.\n6. Inadequate organ functions as reflected in laboratory parameters:\n\n   * Estimated glomerular filtration rate (eGFR) \\\u003C 50 mL\u002Fmin adjusted for participant's body surface area using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI 2021) formula\n   * Platelet count of \\\u003C 100 x 109\u002FL\n   * Absolute neutrophil count (ANC) \\\u003C 1.5 x 109\u002FL\n   * Hemoglobin \\\u003C 9 g\u002FdL\n   * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 x upper limit of normal (ULN), or \\> 5 x ULN for participants with known liver metastases\n   * Total bilirubin \\> 1.5 x ULN, except for participants with documented Gilbert's syndrome who are eligible if total bilirubin ≤ 3 x ULN\n   * For participants not taking warfarin or other anticoagulants: INR ≤1.5 or PT ≤1.5 x ULN; and either PTT or aPTT ≤1.5 x ULN. Participants taking warfarin must be on a stable dose that results in a stable INR \\\u003C3.5. Among participants receiving other anticoagulant therapy, PT or aPTT must be within the intended therapeutic range of the anticoagulant.\n7. Participants requiring blood product transfusion within 2 weeks of first dose of 177Lu-BetaBart are not eligible to participate.\n8. \\*Participants with CRPC who have received prior Lu-177-PSMA radioligand therapy.\n9. Clinically significant cardiovascular disease including but not limited to:\n\n   * Unstable angina\n   * Acute myocardial infarction within 6 months prior to screening\n   * New York Heart Association (NYHA) Class II or greater congestive heart failure\n   * Clinically significant abnormalities in rhythm, conduction or morphology on resting ECG (e.g., complete left bundle branch block, third degree heart block)\n   * Known left ventricular ejection fraction \\\u003C 50%\n   * QTcF \\> 480 msec on screening electrocardiogram (ECG), or congenital long QT syndrome.\n10. Participation in any other interventional investigational trial for treatment of underlying malignancy at the time of informed consent signature.\n11. Participants who are pregnant or breastfeeding.\n12. Major surgery within 4 weeks prior to first dose of 177Lu-BetaBart.\n13. Received anti-cancer therapy, including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy or investigational device, ≤ 28 days (or 5 half-lives for biologic\u002Fnon-cytotoxic agents, whichever is shorter), prior to the first dose of 177Lu-BetaBart.\n14. Known active hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n\n    * Active viral (any etiology) hepatitis participants are excluded.\n    * Participants with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen test and a positive anti hepatitis core antigen antibody test) who have a viral load below the limit quantification (HBV DNA titer \\\u003C 1000 cps\u002FmL or 200 IU\u002FmL) and are not currently on viral suppressive therapy may be eligible and should be discussed with the Sponsor's Medical Monitor (or designee).\n    * Note, participants with a history of HCV infection should have completed curative antiviral treatment and have a viral load below the limit of quantification to be eligible to enroll into the study.\n    * No testing for HBV or HCV is required unless mandated by local health authority.\n15. Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s), including but not limited to active bacterial, fungal, or viral infections requiring systemic therapy.\n16. Untreated moderate to severe hydronephrosis. If hydronephrosis is corrected via stent or nephrostomy, hydronephrosis will be considered resolved.\n17. \\*Prescence of a superscan by nuclear medicine\u002F99mTc bone scan.\n18. Active autoimmune disease that has required systemic treatment within 90 days (i.e., with the use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid \\[stable \u002F low doses of ≤10 mg\u002Fday prednisone or equivalent dose\\]) for adrenal or pituitary insufficiency is allowed.\n19. Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition, which in the judgment of the investigator could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the subject to safety risks.",{"count":315,"type":21},61,[234,76],"A Phase 1\u002F2a Dose Escalation and Expansion Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients with Relapsed\u002FRefractory, Locally Advanced Inoperable, or Metastatic Solid Tumors",[319,320,321,322,323,324,325,326,327,26],"Castration-Resistant Prostate Cancer (CRPC)","Colorectal Cancer","NSCLC (Non-small Cell Lung Cancer)","Ovarian Cancer","Cervical Cancer","Endometrial Cancer","TNBC, Triple Negative Breast Cancer","Small Cell Lung Cancer (SCLC )","Head &Amp; Neck Squamous Cell Carcinoma (HNSCC)",[329,330,331,332,333,334,335,336,337,338,339,340,341,342,343,344,345],"Castration-resistant prostate cancer (CRPC)","colorectal cancer (CRC)","non-small-cell lung cancer (NSCLC)","small-cell lung cancer (SCLC)","head and neck squamous cell carcinoma (HNSCC)","ovarian cancer","cervical cancer","endometrial cancer","triple negative breast cancer (TNBC)","esophageal squamous cell carcinoma (ESCC)","B7-H3","177Lu","radiotheranostics","radioligand therapy","radioimmunotherapy","monoclonal antibody","metastatic solid tumors","2026-03-24",{"date":348,"type":36},"2026-03-27",{"date":350,"type":36},"2026-02-23",{"date":259,"type":21},{"name":353,"class":169},"Radiopharm Theranostics, Ltd",4,{"id":356,"slug":4,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":361,"targetDuration":4,"studyType":74,"phases":363,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":44},"100629929","NCT07481058","KC1036 in Combination With PD-1 Antibody and Platinum-based Chemotherapy for First-line Advanced Esophageal Cancer","A Phase II Clinical Study to Evaluate the Efficacy and Safety of KC1036 Combined With PD-1 Antibody and Platinum-based Chemotherapy as First-line Treatment for Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Males or females aged 18 to 75 years;\n* Histologically or cytologically confirmed esophageal or esophageal-gastric junction squamous cell carcinoma;\n* Patients who have not received prior systemic anti-tumor therapy for the current recurrent or metastatic disease;\n* At least one measurable tumor lesion according to RECIST 1.1;\n* Eastern Cooperative Oncology Group performance status score of 0 or 1;\n* Life expectancy \\> 12 weeks;\n* BMI≥16.0 kg\u002Fm2;\n* Adequate bone marrow, renal, and hepatic function;\n* Female patients of childbearing potential with a negative blood pregnancy test completed within 7 days before the first dose;\n* Patients should participate in the study voluntarily and sign informed consent.\n\nExclusion Criteria:\n\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastasis;\n* Other malignancies within the past 5 years;\n* Known hypersensitivity to any monoclonal antibodies or chemotherapy components;\n* Gastrointestinal abnormalities;\n* High risk of bleeding or fistula due to tumor invasion of adjacent organs, or existing esophageal\u002Ftracheal fistula;\n* Cardiovascular and cerebrovascular diseases;\n* Prior therapy with anti-angiogenic drugs or immunotherapy; Systemic therapy, investigational drugs, or live vaccines within 4 weeks prior to the first dose; Palliative radiotherapy within 2 weeks or major surgery within 28 days prior to enrollment;\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\n* Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE 5.0 Grade 0 or 1;\n* Active autoimmune disease or a history of autoimmune disease requiring systemic treatment;\n* Active infections, including severe infection (CTCAE \\> Grade 2) within 4 weeks, active tuberculosis, or positive status for HIV, HBV, or HCV;\n* Pregnant or lactating women;\n* Female subjects of child-bearing potential and male subjects of reproductive capacity who do not agree to use contraceptive measures during the study and for 6 months after the end of the study;\n* Other conditions assessed by the investigator that would increase safety risks or interfere with the study results.",{"count":362,"type":21},60,[76],"The purpose of this study is to evaluate the efficacy and safety of KC1036 in combination with PD-1 antibody and platinum-based chemotherapy as a first-line treatment for patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).",[26],"2026-03-18",{"date":368,"type":36},"2026-03-20",{"date":370,"type":36},"2025-12-12",{"date":372,"type":21},"2028-12",{"name":374,"class":169},"Beijing Konruns Pharmaceutical Co., Ltd.",{"id":376,"slug":4,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":11,"sex":17,"minAge":381,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":74,"phases":384,"briefSummary":385,"conditions":386,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":262},"100595954","NCT07039162","Study of Tislelizumab Combined With Chemoradiotherapy and Surgery for Unresectable Esophageal Squamous Cell Carcinoma","Phase II Study of Tislelizumab Combined With Induction Chemoradiotherapy and Subsequent Conversion Surgery for Locally Advanced Unresectable ESCC","Inclusion Criteria:\n\n1. Patients had histologically confirmed, squamous-cell carcinoma of the esophagus\n2. Clinical T4 cancer, at least one unresectable metastatic regional lymph node due to invasion into an adjacent organ, or computed tomographic (CT) evidence of M1Lym, such as fixed supraclavicular nodes. Regional lymph nodes are defined on the basis of criteria specified by the eighth edition of the Union for International Cancer Control TNM staging system (Sobin and Wittekind, 2016).\n3. An age of at least 20 years\n4. An Eastern Cooperative Oncology Group performance-status score 0 or 1\n5. Adequate major organ functions\n\n   * WBC ≥3,500\u002Fmm3\n   * Hemoglobin ≥ 9.0 g\u002FdL\n   * Platelet ≥ 80,000\u002Fmm3\n   * Total bilirubin ≤ 2-fold the upper limit of normal (ULN)\n   * ALT and AST ≤ 5-fold the ULN AND ≤200 U\u002FL\n   * PT, aPTT and INR ≤1.5-fold the ULN\n   * Albumin ≥2.5 g\u002FdL\n   * Creatinine clearance ≥50 ml\u002Fmin (based upon 24 hours urine collection or calculated by Cockroft-Gault formula)\n\n     * Male: ((140 - age) × weight \\[kg\\])\u002F(72 × serum creatinine \\[mg\u002FdL\\])\n     * Female: 0.85 x estimate for male\n6. Women of childbearing potential (including women with chemical menopause or no menstruation for other medical reasons) must agree to use contraception from the time of informed consent until 5 months or more after the last dose of investigational products. (Women of childbearing potential are defined as all women after the onset of menstruation who are not postmenopausal and have not been surgically sterilized (e.g., hysterectomy, bilateral tubal ligation, bilateral oophorectomy). Postmenopause is defined as amenorrhea for ≥12 consecutive months without specific reasons.)\n7. Men must agree to use contraception from the start of study treatment until 3 months or more after the last dose of the investigational product.\n8. Patients must be willing to undergo definitive resection with lymph node dissection\n9. Participants must have signed written informed consent form in accordance with regulatory and institutional guidelines.\n\nExclusion Criteria:\n\n1. Patient has received systemic therapy for advanced ESCC.\n2. Patients had distant metastasis, including liver, lung, bone and brain metastases.\n3. Patients had esophageal perforation or esophageal fistula\n4. Patients had tumor bleeding\n5. Patients had active infection(e.g. tuberculosis).\n6. History or known human immunodeficiency virus.\n7. Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll.\n8. Systemic immunosuppression therapy or chronic systemic steroid therapy (more than 10mg daily of prednisolone)\n9. Known hepatitis B (HBsAg reactive) or C virus infection (positive anti HCV)\n\n   * Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA \\\u003C 500 IU\u002FmL or \\\u003C 2500 copies\u002FmL) can be enrolled. Patients with detectable HBsAg or detectable HBV DNA should be managed per treatment guidelines. Patients receiving antivirals at screening should have been treated for \\> 2 weeks before randomization\u002Fenrollment.\n   * Patients with a positive HCV antibody test followed by a negative HCV RNA test at screening are eligible.\n10. Previous therapy targeting T-cell costimulating or immune-checkpoint pathways\n11. Prior or concurrent malignancies within the last 3 years, with the exception of carcinoma in situ of the cervix, or basal type skin cancer\n12. Any major surgery within 4 weeks before study enrollment.\n13. Pregnant women or nursing mothers, or positive pregnancy tests\n14. Patients had allogeneic stem cell transplantation or organ transplantation.\n15. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including NYHA Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, and\u002For other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention.\n16. Patients with interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, or acute lung diseases\n17. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n18. Other patients judged by the investigators be inappropriate as subjects of this study","20 Years",{"count":383,"type":21},45,[76],"This is a Phase II, open-label, single-arm, multicenter study evaluating the safety and efficacy of combining Tislelizumab with induction chemoradiotherapy (CRT), followed by conversion surgery, in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC).\n\nPatients will receive induction CRT with weekly paclitaxel and cisplatin along with Tislelizumab, followed by two cycles of consolidation Tislelizumab-chemotherapy. If the tumor becomes resectable, patients will undergo surgery.\n\nThe primary goal is to assess the 2-year overall survival (OS) rate. Secondary outcomes include pathological complete response (pCR), conversion rate, R0 resection rate, disease-free survival (DFS), recurrence-free survival (RFS), and treatment-related adverse events.",[26,387],"Locally Advanced Unresectable Esophageal Cancer","2026-02-24",{"date":390,"type":36},"2026-02-27",{"date":392,"type":36},"2025-09-26",{"date":394,"type":21},"2028-12-31",{"name":396,"class":43},"Ming-Yu Lien",{"id":398,"slug":4,"hasResults":11,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":403,"targetDuration":4,"studyType":74,"phases":405,"briefSummary":406,"conditions":407,"keywords":408,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":44},"100623961","NCT07403435","Short-course Radiotherapy Combined With Serplulimab and Chemotherapy as Neoadjuvant Treatment for Resectable ESCC","Short-course Radiotherapy Combined With Serplulimab and Chemotherapy as Neoadjuvant Treatment for Resectable Esophageal Squamous Cell Carcinoma: a Single-center, Open-label Phase II Clinical Trial","Inclusion Criteria:\n\n1. Patients with histologically confirmed squamous cell carcinoma of the esophagus (ESCC) staged as cT1-2N+M0 and cT3NanyM0 (AJCC 8th edition);\n2. Aged between 18-75 years;\n3. ECOG performance status score of 0-1;\n4. The following laboratory tests confirm that the bone marrow, liver and kidney functions meet the requirements for study participation\n\n   1. Hemoglobin ≥90g\u002FL; ANC≥1.5×10\\^9\u002FL;platelet count ≥100×10\\^9\u002FL (patients must not have received blood transfusion or growth factor support within 14 days of blood sample collection);\n   2. ALT, AST ≤2.5\\*ULN; ALP ≤2.5\\*ULN;\n   3. Serum total bilirubin \\\u003C1.5\\*ULN\n   4. Serum creatinine \\\u003C1.5\\*ULN or estimated glomerular filtration rate (eGFR) ≥60ml\u002Fmin\u002F1.73m\\^2;\n   5. Serum albumin ≥30g\u002FL;\n   6. INR or PT ≤1.5 \\*ULN, unless the patient is on anticoagulant therapy and the PT is within the expected therapeutic range; g. Activated partial thromboplastin time (APTT) ≤1.5 times ULN.\n5. No severe concomitant diseases with a life expectancy of less than 5 years;\n6. Voluntary and able to comply with the study protocol during the study period;\n7. Provide written informed consent prior to entering the study, and the patient has been informed that they can withdraw from the study at any time without any loss.\n\nExclusion Criteria:\n\n1. History of other malignancies in the past or concurrently, except for cured basal cell carcinoma of the skin and in situ cervical carcinoma; patients with small gastric stromal tumors and other tumors judged by the investigator to not affect the patient's life in the short term may be excluded;\n2. Participation in other drug clinical trials within four weeks;\n3. Patients with any active autoimmune disease or history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaryitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; asthma that was completely resolved in childhood and does not require any intervention in adulthood may be included; asthma requiring medical intervention with bronchodilators cannot be included);\n4. Patients currently using immunosuppressants, or systemic corticosteroid therapy for immunosuppressive purposes (dose \\>10mg\u002Fday prednisone or other equivalent corticosteroids), and continued use within two weeks prior to enrollment;\n5. Any active malignant tumor within two years, except for the specific cancer being studied in this trial and cured locally recurrent cancer (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, in situ cervical or breast carcinoma);\n6. Patients with known central nervous system (CNS) metastasis or history of CNS metastasis at screening. For patients clinically suspected of CNS metastasis, a CT or MRI examination must be performed within 28 days before treatment to rule out CNS metastasis;\n7. History of unstable angina; newly diagnosed angina within three months before screening or myocardial infarction event within six months before screening; arrhythmia (including QTcF: males ≥450 ms, females ≥470 ms) requiring long-term antiarrhythmic medication and New York Heart Association class ≥II heart failure;\n8. Urine routine indicating proteinuria ≥++ and confirmed 24-hour urinary protein \\>1.0 g;\n9. For female subjects: should be surgically sterilized, postmenopausal patients, or agree to use a medically recognized contraceptive method during the study treatment period and for six months after the end of the study treatment; serum or urine pregnancy test must be negative within seven days before study enrollment, and must not be lactating. For male subjects: should be surgically sterilized, or agree to use a medically recognized contraceptive method during the study treatment period and for six months after the end of the study treatment;\n10. Patients who have undergone liver transplantation;\n11. Infectious pneumonia, non-infectious pneumonia, interstitial pneumonia, and other patients requiring the use of corticosteroids;\n12. History of chronic autoimmune diseases, such as systemic lupus erythematosus;\n13. History of inflammatory bowel diseases such as ulcerative colitis, Crohn's disease, and history of chronic diarrheal diseases such as irritable bowel syndrome;\n14. History of sarcoidosis or tuberculosis;\n15. Active hepatitis B, hepatitis C, and HIV infection;\n16. Untreated active syphilis;\n17. History of substance abuse with psychotropic drugs and unable to quit or with psychiatric disorders;\n18. Pleural effusion or ascites with clinical symptoms requiring clinical intervention;\n19. History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;\n20. According to the investigator's judgment, there are serious concomitant diseases that endanger patient safety or affect the patient's ability to complete the study.",{"count":404,"type":21},22,[76],"This study includes patients with resectable esophageal squamous cell carcinoma who will undergo local radiotherapy (PTV: 1.5Gy Bid, for 5 days), followed by neoadjuvant treatment with Serplulimab combined with cisplatin and paclitaxel for three cycles. Afterward, they will undergo surgery. Postoperatively, researchers will select adjuvant treatment plans based on the patients' conditions.",[26],[409,410,411],"Short-course radiotherapy","neoadjuvant","esophageal squamous cell carcinoma","2026-02-04",{"date":414,"type":36},"2026-02-11",{"date":416,"type":21},"2026-02-15",{"date":418,"type":21},"2030-05-31",{"name":420,"class":43},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":422,"slug":4,"hasResults":11,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":426,"eligibilityCriteria":427,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":428,"targetDuration":4,"studyType":74,"phases":430,"briefSummary":431,"conditions":432,"keywords":433,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":44},"100589300","NCT06952621","Neoadjuvant Treatment of Toripalimab Combined With Nab-paclitaxel and Platinum Versus Neoadjuvant Docetaxel Combined With Cisplatin and 5-fluorouracil (DCF) in Esophageal Squamous Cell Carcinoma","A Multicenter, Randomized Controlled Clinical Study Comparing Neoadjuvant Toripalimab Combined With Nab-paclitaxel and Platinum Versus Neoadjuvant Docetaxel Combined With Cisplatin and 5-fluorouracil (DCF) in the Treatment of Resectable Locally Advanced Esophageal Squamous Cell Carcinoma","TD-NEOE3V3","Inclusion Criteria:\n\n* Patients who meet all of the following criteria are eligible to participate in the study:\n\n  1. Voluntarily sign the written informed consent form;\n  2. Age 18-75 years, inclusive of 18 and 75 years, both male and female;\n  3. Life expectancy of ≥3 months;\n  4. Expected to achieve R0 resection;\n  5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n  6. Patients with resectable locally advanced (T1 N1-3 M0 or T2-4a N0-3 M0 (T2≥3cm or poorly differentiated)) thoracic esophageal squamous cell carcinoma confirmed by histology and who have not previously received treatment;\n  7. No suspicious metastatic lymph nodes in the neck (excluding regional lymph nodes in the upper thoracic esophageal cancer area) as suggested by neck ultrasound or enhanced CT, and no systemic metastasis detected by imaging studies;\n  8. Presence of a definite tumor lesion;\n  9. Good organ function as indicated by screening laboratory test results:\n\n     1. Hematology (no blood transfusions or treatment with blood products or granulocyte colony-stimulating factor within 14 days): Neutrophil count (NEU) ≥1.5×10⁹\u002FL (1,500\u002Fmm³); Platelet (PLT) count ≥100×10⁹\u002FL (100,000\u002Fmm³); Hemoglobin ≥90 g\u002FL.\n     2. Liver: Total bilirubin (TBil) ≤1.5×ULN; or for participants with total bilirubin levels \\\u003C1.5×ULN, direct bilirubin within normal limits; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN;\n     3. Kidney: Serum creatinine ≤1.5×ULN or calculated creatinine clearance (CrCl) ≥60 mL\u002Fmin (using the Cockcroft-Gault formula);\n     4. Coagulation function: International normalized ratio (INR) ≤1.5, and prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤1.5×ULN;\n  10. Fertile males or females of childbearing potential must use effective contraception methods (such as oral contraceptives, intrauterine devices, or barrier methods combined with spermicides) during the trial and continue contraception for 6 months after the end of treatment;\n  11. Good compliance and willingness to cooperate with follow-up visits.\n\nExclusion Criteria:\n\n* Patients who meet any of the following criteria are ineligible for this study:\n\n  1. Previous treatment with PD-1\u002FPD-L1 agents or drugs targeting another T-cell receptor (e.g., CTLA-4, OX-40, etc.);\n  2. Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\n  3. Active autoimmune disease or suspicion of such, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc., with the exception of type 1 diabetes and hypothyroidism controlled with stable-dose replacement therapy, and skin diseases not requiring systemic treatment (e.g., psoriasis, vitiligo);\n  4. History of interstitial lung disease ≥ Grade 2;\n  5. Received systemic corticosteroids (prednisone \\>10mg\u002Fday or equivalent) or other immunosuppressive drugs within 14 days prior to the first study drug administration;\n  6. History of immunodeficiency, including other acquired or congenital immunodeficiency diseases, history of organ transplantation, or having undergone allogeneic hematopoietic stem cell transplantation or solid organ transplantation;\n  7. Received live vaccine within 4 weeks prior to the first study drug administration;\n  8. Presence of severe cardiovascular and cerebrovascular diseases:\n\n     1. Uncontrolled hypertension or pulmonary arterial hypertension;\n     2. Unstable angina or myocardial infarction, coronary artery bypass grafting, or stent implantation within 6 months prior to study drug administration;\n     3. Chronic heart failure with cardiac function ≥ Grade 2 (New York Heart Association \\[NYHA\\] classification);\n     4. Left ventricular ejection fraction (LVEF) \\\u003C50%;\n     5. Severe arrhythmias requiring drug treatment (excluding atrial fibrillation or paroxysmal supraventricular tachycardia). For example: male QTcF \\>450 msec or female QTcF \\>470 msec, complete left bundle branch block, third-degree atrioventricular block;\n     6. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to study drug administration;\n  9. Presence of uncontrollable or severe underlying diseases, including but not limited to active infections requiring systemic antibiotic therapy;\n  10. Positive test results for human immunodeficiency virus (HIV) antibodies, active hepatitis B or C. The following cases are allowed to participate in this study:\n\n      1. Positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg), but HBV DNA below the detection limit of the study center (negative) or \\\u003C500IU\u002FML, and after clinical treatment and presentation, the investigator determines that there is no active infection;\n      2. Positive for hepatitis C antibody, but HCV RNA below the detection limit of the study center (negative);\n  11. Known active tuberculosis (TB). Patients suspected of having active TB must be excluded by chest X-ray, sputum tests, and clinical symptoms and signs;\n  12. Presence of other active malignancies within the past 2 years, excluding malignancies that are expected to be cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell carcinoma of the skin, or ductal carcinoma in situ of the breast treated with radical surgery);\n  13. History of substance abuse or mental disorders that cannot be controlled;\n  14. Pregnant or breastfeeding women;\n  15. Presence of other severe, acute, or chronic medical or psychiatric conditions or laboratory abnormalities that, in the investigator's judgment, may increase the risk associated with participation in the study or may interfere with the interpretation of study results.",{"count":429,"type":21},390,[152],"This study is a randomized, controlled, open-label, multicenter Phase III clinical trial, designed to evaluate the efficacy and safety of neoadjuvant toripalimab in combination with nab-paclitaxel and platinum versus neoadjuvant docetaxel in combination with cisplatin and 5-fluorouracil (DCF) in the treatment of resectable locally advanced esophageal squamous cell carcinoma",[26],[434,435,410],"toripalimab","DCF","2026-01-29",{"date":438,"type":36},"2026-01-30",{"date":440,"type":21},"2026-02-01",{"date":442,"type":21},"2028-12-28",{"name":90,"class":43},{"id":445,"slug":4,"hasResults":11,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":450,"enrollmentInfo":451,"targetDuration":4,"studyType":74,"phases":453,"briefSummary":454,"conditions":455,"keywords":457,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":463,"completionDateStruct":464,"leadSponsor":466,"locationsCount":44},"100621919","NCT07376876","Indocyanine Green-guided Omental Shield Anastomosis for Cervical Esophagogastric Anastomosis in Minimally Invasive McKeown Esophagectomy","Indocyanine Green-guided Omental Shield Anastomosis (ICG-OSA) for Cervical Esophagogastric Anastomosis in Minimally Invasive McKeown Esophagectomy: a Single-center, Single-arm, Open-label Clinical Study","Inclusion Criteria:\n\n1. Age 18 to 80 years, of both sexes;\n2. Pathological diagnosis: Histologically confirmed esophageal squamous cell carcinoma (ESCC) by biopsy;\n3. Clinical staging: Preoperative clinical stage cT1-4aN0-3M0 (according to the 8th edition AJCC staging criteria), evaluated by the thoracic surgery team as eligible for radical McKeown esophagectomy;\n4. Performance status ECOG 0-1；\n5. Major organ function (cardiovascular, respiratory, digestive, hematological systems) assessed as having no contraindications for chemotherapy or immunotherapy, and no surgical contraindications;\n6. Able to understand and comply with study protocol requirements, and willing to accept and undergo standardized postoperative follow-up;\n7. Able to understand and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Allergy history: History of allergy to indocyanine green (ICG), iodide, or iodinated contrast agents (ICG contains iodine, and allergy may cause severe anaphylactic reactions);\n2. Severe hepatic or renal dysfunction: Severe hepatic insufficiency (Child-Pugh Class C) or severe renal insufficiency (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²), affecting ICG metabolism and excretion;\n3. Unfavorable tumor location: Tumor located in the cervical or upper thoracic esophagus (\\\u003C25 cm from the incisors), making it difficult to ensure negative proximal resection margin;\n4. Previous surgery history: Prior history of esophageal, gastric, or mediastinal surgery resulting in altered anatomy or severe adhesions;\n5. Multiple primary cancers: Concurrent active malignant tumors in other sites (except cured basal cell carcinoma of the skin or cervical carcinoma in situ);\n6. Special physiological status: Pregnant or lactating women, or those with planned pregnancy during the study period who are unwilling to use effective contraception;\n7. Cognitive and behavioral issues: Presence of severe psychiatric illness, cognitive impairment, or history of substance abuse that would preclude compliance with study procedures;\n8. Participation in other studies: Currently enrolled in other interventional clinical trials that may interfere with the results of this study;\n9. Investigator judgment: Investigator considers the patient unsuitable for this clinical study (e.g., intraoperative exploration reveals severe tumor invasion of major structures such as the aorta or trachea, making R0 resection unachievable).","80 Years",{"count":452,"type":21},73,[76],"Brief Summary Study title: Indocyanine green (ICG)-guided omental shield anastomosis (ICG-OSA) technique for cervical esophagogastric anastomosis in esophageal cancer surgery Purpose: To evaluate whether a novel surgical technique can reduce the risk of anastomotic leakage after minimally invasive esophageal cancer surgery.\n\nEligible participants: Adults aged 18-80 years with histologically confirmed esophageal squamous cell carcinoma (ESCC) in the middle or lower thoracic esophagus who are scheduled for esophagectomy.\n\nThe technique: All participants will undergo the ICG-OSA procedure, which uses indocyanine green fluorescence imaging to assess gastric perfusion, creates a T-shaped esophagogastric anastomosis, and wraps the anastomosis with a pedicled omental flap.\n\nOutcome assessments: The primary outcome is anastomotic leakage rate within 30 days after surgery. Secondary assessments include surgical site infection, anastomotic stricture, and hospitalization costs.\n\nStudy site: Daping Hospital, Army Medical Center, Chongqing, China Study duration: December 2025 to March 2027 Contact: For more information, please contact the research team at Daping hospital.",[26,456],"Esophageal Cancer",[458,459,460,26],"Indocyanine Green Fluorescence Navigation","Anastomotic Leakage","Omental Shield","2026-01-26",{"date":436,"type":36},{"date":282,"type":21},{"date":465,"type":21},"2026-12-31",{"name":467,"class":43},"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University",{"id":469,"slug":4,"hasResults":11,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":473,"eligibilityCriteria":474,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":475,"targetDuration":477,"studyType":23,"phases":4,"briefSummary":478,"conditions":479,"keywords":481,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":492,"leadSponsor":494,"locationsCount":4},"100620124","NCT07353541","Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma","An Evaluation of the Safety and Efficacy of a Standardized Diagnosis and Treatment Protocol for Esophageal Fistula in Patients With Esophageal Squamous Cell Carcinoma: A Single-Arm, Multi-Center Clinical Study","PKU-ESCC-EF","Inclusion Criteria:\n\n* Voluntary participation and provision of written informed consent.\n* Age between 18 and 75 years (inclusive).\n* Histologically confirmed diagnosis of esophageal squamous cell carcinoma.\n* Radiologically confirmed unresectable, advanced disease.\n* Newly diagnosed esophageal fistula (including tracheoesophageal fistula or mediastinal esophageal fistula).\n* Previous receipt of ≤ 3 lines of systemic anti-tumor therapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Adequate organ and marrow function within 7 days prior to potential anti-tumor treatment, as defined by:\n* Hemoglobin ≥ 9.0 g\u002FdL\n* Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n* Platelet count ≥ 100 × 10⁹\u002FL\n* Total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN)\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (or ≤ 5 × ULN in the presence of liver metastases)\n* Serum creatinine ≤ 1.5 × ULN\n* Adequate cardiac, pulmonary, and renal function to be eligible for general anesthesia, with no contraindications to general anesthesia.\n\nExclusion Criteria:\n\n* Patients with postoperative anastomotic fistula.\n* Uncontrolled active bleeding.\n* Presence of a concurrent primary malignancy other than esophageal carcinoma.\n* Clinically significant cardiovascular disease, including but not limited to:\n* Heart failure (NYHA Class III-IV)\n* Uncontrolled coronary artery disease, cardiomyopathy, or arrhythmia\n* Uncontrolled hypertension\n* History of myocardial infarction within the past 1 year\n* Neurological or psychiatric disorders that impair cognitive ability, including the presence of central nervous system metastases.\n* Uncontrolled, active severe clinical infection ( \\> Grade 2 per NCI-CTCAE version 5.0) within 14 days prior to enrollment, including active tuberculosis (this is a contraindication for anti-tumor therapy, not for interventional procedures).\n* Known or self-reported HIV infection, or active Hepatitis B or Hepatitis C.\n* A history of interstitial lung disease (e.g., interstitial pneumonia, pulmonary fibrosis), or evidence of interstitial lung disease on baseline chest X-ray\u002FCT.",{"count":476,"type":21},32,"6 Months","This prospective, multi-center, observational registry study (PKU-ESCC-EF) aims to evaluate the safety and effectiveness of a standardized diagnosis and treatment protocol for esophageal fistula (EF) in patients with advanced esophageal squamous cell carcinoma (ESCC). Esophageal fistula is a severe complication that often leads to life-threatening infections and poor nutrition. This study will observe patients receiving a comprehensive management strategy, which includes fistula sealing with esophageal or airway stents, targeted anti-infective therapy, nutritional support, and subsequent systemic anti-tumor therapy. The primary goal is to assess whether this standardized approach can improve overall survival and enable more patients to receive further anti-cancer treatments.",[26,480],"Esophageal Fistula",[28,480,482,483,484,485,486,487],"Standardized Management","Stent Placement","Nutritional Support","Observational Study","Registry Study","Real-world Evidence","2026-01-18",{"date":490,"type":36},"2026-01-20",{"date":440,"type":21},{"date":493,"type":21},"2026-04-01",{"name":495,"class":43},"Peking University Cancer Hospital & Institute",{"id":497,"slug":4,"hasResults":11,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":501,"eligibilityCriteria":502,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":74,"phases":504,"briefSummary":505,"conditions":506,"keywords":508,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":44},"100620576","NCT07359417","MR-Guided Radiotherapy Dose Escalation Trial for Esophageal Squamous Cell Carcinoma","Improving Outcome of Patients With Squamous Cell ESophageal CArcinoma by Dose escaLATion Using High-prEcision Mr-guided Radiotherapy (ESCALATE): a Phase 1 Dose Finding Trial","ESCALATE","Inclusion criteria\n\nIn order to be eligible for this study, a subject must meet all of the following criteria:\n\n* Histologically confirmed squamous cell carcinoma of the esophagus or GE- junction (Siewert I\u002FII)\n* Potentially resectable, locally advanced esophageal tumor (cT1bN+, cT2-3, N0-3, M0) based on standard primary staging by EUS and 18F-FDG PET-CT\n* Scheduled to receive neoadjuvant chemoradiotherapy according to CROSS-regimen: weekly administration of carboplatin and paclitaxel for 5 weeks and concurrent radiotherapy (41.4Gy in 23 fractions, 5 days per week), followed by esophagectomy (as judged by the multidisciplinary tumor board)\n* Tumor length ≤ 10 cm\n* Age ≥ 18 years\n* WHO performance status 0-2\n* Signed informed consent\n* Tumor volume that can be defined on MRI at baseline (T2w and DW-MRI)\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule before patient registration\u002Frandomization, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations.\n\nExclusion criteria\n\nA subject who meets any of the following criteria will be excluded from participation in this study:\n\n* Adenocarcinoma of the esophagus\n* Non-resectable, inoperable or metastatic squamous cell carcinoma of the esophagus or GE-junction\n* Siewert type III\n* Squamous cell carcinoma of the cervical esophagus\n* Prior (chemo)radiotherapy to the mediastinum\n* Prior esophageal surgery that impedes the ability to perform an esophagectomy\n* Patients with multiple primary carcinomas of the esophagus\n* Patients who meet exclusion criteria for MRI\n* Irradical endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of primary tumor prior to start of neoadjuvant chemoradiotherapy\n* Pregnant or breast-feeding patients\n* Patients in whom it is not in their best interest to participate (in the judgment of the PI)",{"count":199,"type":21},[234],"SUMMARY Rationale: Esophageal cancer (EC) is the seventh most frequently diagnosed cancer and the sixth leading cause of cancer-related death worldwide. As a result of the late onset of symptoms, most patients with EC present in an advanced stage with a corresponding poor prognosis. Poor disease outcome after surgery alone (5-yr overall survival between 25-40%) prompted many researchers to explore neoadjuvant chemoradiotherapy (nCRT) or neoadjuvant or perioperative chemotherapy (nCT\u002FpCT) approaches. nCRT has led to pathological complete response (pCR) rate in squamous cell EC of almost 50%. Patients with a pCR have a favorable prognosis with 5-year OS \\>50%. In addition, patients who will achieve a pCR might be candidates for an organ preserving treatment strategy. Current standard nCRT consists of a relatively low dose of radiation compared to other tumors in the same area. The investigators hypothesize that increasing the dose of radiation will lead to increased local tumor control and pCR rates.\n\nObjective: The main objective of this study is to determine the maximum tolerated dose (MTD) of 2-fraction boost MRI-guided radiotherapy (MRgRT) for patients with SCC following CROSS therapy. The secondary objectives are feasibility, non-dose limiting toxicity, oncological outcomes and to explore variables for early response evaluation.\n\nStudy design: 6+3 dose-escalation design with 3 radiotherapy dose levels. Study population: Patients with a resectable squamous cell esophageal carcinoma who are eligible for nCRT, surgery and MRgRT.\n\nIntervention: 2 sequential, homogenous boost fractions of 4-7 Gy on the gross tumor volume (GTV) in the week following CROSS using MR-guided online adaptive radiotherapy on the MR-linac. Start in dose level 0, of 2 x 5Gy boost per patient, and if safe this is increased step-wise to a maximum dose level 2 of 2 x 7Gy per patient.\n\nMain study parameters\u002Fendpoints: The primary endpoint is the incidence of a dose limiting toxicity (DLT). Early DLT is defined as radiation induced esophageal fistula\u002F perforation\u002F hemorrhage\u002F necrosis or tracheal, bronchial or bronchopleural fistula\u002Ftracheal or bronchopulmonary hemorrhage grade ≥ 3 or any non-hematological grade 4 toxicity according to Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0 occurring within 14 weeks after the start of radiotherapy and before surgery or the postponing of surgery \\> 14 weeks after the end of radiotherapy due to any grade of treatment-related toxicity. Subacute DLT is defined as peri- and\u002For postoperative complications occurring within 30 days after surgery, defined as postoperative anastomotic leakage or pneumonitis ≥ 3b according to Clavien-Dindo. Secondary endpoints are non-DLT toxicity, the technical feasibility of dose delivery, perioperative complications, and oncological outcomes including R0 resection rate, histopathological tumor response, local and regional recurrence and death from any cause.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: The benefits for the patients may include higher probability of complete pathological response that initially leads to increased survival and could eventually result in organ-sparing treatment programs. Compared to standard treatment, the CROSS regimen including the sequential boost will take 2 days extra in the final week of CROSS. Possible risks include higher radiation toxicity and surgical complication rates. However, it is expected this increase to be minor, for the investigators will use dose constraints on organs at risk, which are associated with low radiation-induced toxicity, and they will not be exceeded.",[26,507],"Esophageal Cancer, Squamous Cell",[509,510,511,512,513],"MR-Guided Radiotherapy","Adaptive Radiotherapy","MR-Linac","Dose Escalation","Phase 1 Trial","2026-01-13",{"date":516,"type":36},"2026-01-22",{"date":518,"type":36},"2025-05-30",{"date":520,"type":21},"2028-05-01",{"name":522,"class":43},"UMC Utrecht",{"id":524,"slug":4,"hasResults":11,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":530,"targetDuration":4,"studyType":74,"phases":531,"briefSummary":532,"conditions":533,"keywords":534,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":44},"100617360","NCT07317609","Neoadjuvant Immunotherapy Combined With Chemotherapy Sequenced With Endoscopic Resection for Esophageal Cancer (Endosurgery-02)","Safety and Feasibility of Neoadjuvant Immunotherapy Combined With Chemotherapy Sequenced With Endoscopic Resection for Esophageal Cancer (Endosurgery-02)","Endosurgery-02","Cohort A - Potentially resectable ESCC:\n\nInclusion Criteria：\n\n1. Age range: 18-80 years old;\n2. Patients diagnosed with esophageal squamous cell carcinoma (ESCC) through histopathological examination of biopsy tissues from the primary tumor;\n3. Patients with potentially resectable esophageal cancer confirmed by imaging and endoscopic examinations (T1b-3, N0, M0, with a tumor size not exceeding 5 cm and occupying less than 2\u002F3 of the luminal circumference); Patients who have not received any antitumor treatment, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, and targeted therapy;\n4. Patients with a preoperative Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n5. Patients with a preoperative American Society of Anesthesiologists (ASA) physical status classification of I-III;\n6. Female patients of reproductive age should have a negative pregnancy test and be willing to use effective contraceptive methods during the study period;\n7. Patients who have signed the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with potential tracheoesophageal fistula or aortoesophageal fistula;\n2. Patients with severe malnutrition or requiring tube feeding;\n3. Patients with other malignancies that have not been cured within the past 2 years (except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the cervix);\n4. Patients with active autoimmune diseases or a history of autoimmune diseases or symptoms that require systemic corticosteroid treatment or anti-autoimmune drug therapy;\n5. Immunocompromised patients, or patients who are still receiving systemic steroids (prednisone \\> 10 mg\u002Fday or equivalent) or other forms of immunosuppressive therapy within 7 days before the first dose of neoadjuvant therapy in this study;\n6. Patients with active infections requiring systemic treatment within 7 days before the first neoadjuvant therapy in this study;\n7. Patients with a history of allogeneic organ or stem cell transplantation;\n8. Patients with allergies to drugs or related components involved in this study;\n9. Patients who are currently participating in any other clinical study.\n\nCohort B - Surgery-contraindicated ESCC:\n\nInclusion Criteria:\n\n1. Individuals aged above 18 years;\n2. Patients diagnosed with esophageal squamous cell carcinoma through histopathological examination of biopsy tissues from the primary tumor;\n3. Patients with esophageal cancer deemed as surgically contraindicated (including those with cervical esophageal cancer, surgical contraindications, those who refuse surgery, or those considered high-risk for esophagectomy, defined as having at least one of the following characteristics: (1) age over 75 years, (2) Charlson comorbidity index \\>= 2, (3) presence of moderate lung dysfunction, (4) malnutrition (with a body mass index below 18 kg\u002Fm\\^2)), with a clinical staging of cT1b-3N0M0, a tumor size not exceeding 5 cm, and occupying less than 2\u002F3 of the luminal circumference;\n4. Patients who have not undergone any antitumor treatment, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, and targeted therapy;\n5. Female patients of reproductive age should have a negative pregnancy test and be willing to adopt effective contraceptive measures during the study period;\n6. Patients who have signed the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with allergies to the drugs or related components involved in this study;\n2. Patients who are currently participating in any other clinical study.",{"count":362,"type":21},[234],"This single-center, prospective, single-arm study will evaluate whether giving neoadjuvant chemoimmunotherapy can safely shrink esophageal cancer and allow organ-preserving endoscopic removal in selected patients. Adults with esophageal cancer will receive at least two 3-week cycles of a PD-1 inhibitor (tislelizumab 200 mg on Day 1) plus carboplatin (AUC 3-5, Day 1) and nab-paclitaxel (≤260 mg\u002Fm², Day 1). During treatment, routine safety tests are performed. About 3-4 weeks after completing at least two cycles, participants undergo clinical reassessment with examinations and imaging (such as endoscopy, endoscopic ultrasound, PET\u002FCT or CT of the neck, chest, and upper abdomen) to evaluate tumor shrinkage and possible spread. Tumor response is assessed using RECIST 1.1. If a clinical complete response is achieved without obvious nodal disease, endoscopic resection may be performed to preserve the esophagus; otherwise, patients may proceed to surgery or concurrent chemoradiation per clinical judgment. The study focuses on feasibility and safety of this organ-preserving approach and describes tumor responses after therapy. Potential benefits include tumor shrinkage and avoiding major surgery in selected cases; risks include side effects of standard chemotherapy\u002Fimmunotherapy and procedure-related discomforts from biopsies or endoscopic treatments.",[26],[535],"neoadjuvant, chemoimmunotherapy, tislelizumab, carboplatin, nab-paclitaxel, endoscopic submucosal dissection\u002FESD","2026-01-02",{"date":538,"type":36},"2026-01-05",{"date":540,"type":36},"2025-07-15",{"date":542,"type":21},"2027-09-30",{"name":544,"class":43},"Shanghai Zhongshan Hospital",{"id":546,"slug":4,"hasResults":11,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":4,"eligibilityCriteria":550,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":551,"targetDuration":4,"studyType":74,"phases":552,"briefSummary":553,"conditions":554,"keywords":555,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":561,"leadSponsor":563,"locationsCount":44},"100615238","NCT07290010","The Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy as the First-line Treatment for Esophageal Squamous Cell Carcinoma","A Clinical Trial to Explore the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy as the First-line Treatment for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Age ≥18 years old, gender not limited;\n2. Unresectable, recurrent or advanced metastatic esophageal squamous cell carcinoma confirmed by histopathological examination (excluding adenosquamous carcinoma mixed type and other pathological types);\n3. For patients who have previously received adjuvant\u002Fneoadjuvant chemotherapy\u002Fchemoradiotherapy, or radical concurrent chemoradiotherapy , the time from the last treatment to disease recurrence is more than 6 months;\n4. ECOG 0-1;\n5. According to RECIST v1.1, there is at least one measurable lesion;\n6. Be capable of providing newly obtained or archived tissue samples for immunohistochemical analysis of PD-L1 expression;\n7. The patient's organ functions are normal, with no serious abnormalities in blood, heart, lung, liver or kidney functions, and no immune deficiency diseases.\n8. The patient has normal coagulation function and no active bleeding or thrombotic diseases.\n9. Expected survival time ≥12 weeks;\n10. Male subjects who are female of childbearing age or whose sexual partners are female of childbearing age must take effective contraceptive measures throughout the treatment period and for 6 months after the treatment period.\n11. Voluntarily sign a written informed consent form and be able to comply with the visitation and related procedures stipulated in the plan\n\nExclusion Criteria:\n\n1. Locally advanced esophageal cancer that can be potentially cured through radical surgical resection or radiotherapy;\n2. Esophageal squamous cell carcinoma that is known to have complete obstruction under endoscopy and requires interventional treatment to relieve the obstruction;\n3. There is a risk of perforation after stent implantation in the esophageal or tracheal cavity;\n4. Has received systemic treatment for advanced or metastatic esophageal squamous cell carcinoma in the past;\n5. Other malignant tumors diagnosed within 5 years prior to the first administration, except for effectively treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma and\u002For effectively resected cervical cancer and\u002For breast cancer in situ;\n6. Severe infection occurs (CTCAE\\>grade 2), or active pulmonary inflammation;\n7. Previous or current interstitial pneumonia, pneumoconiosis, drug-related pneumonia, or severe lung function impairment;\n8. Patients with active tuberculosis infection;\n9. Participate in another interventional clinical study simultaneously, unless participating in an observational (non-interventional) clinical study or being in the follow-up stage of an interventional study;\n10. Patients with congenital or acquired immune deficiencies, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU\u002Fml), hepatitis C (positive hepatitis C antibody and HCV-RNA above the detection limit), or patients with co-infection of hepatitis B and hepatitis C;\n11. There is a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n12. Having undergone major surgical operations (craniotomy, thoracotomy or laparotomy) within 4 weeks prior to the first dose of the study treatment or expecting to undergo major surgeries during the study treatment period;\n13. It is known that there are symptomatic central nervous system metastases and\u002For cancerous meningitis (except for stable brain metastases that do not require steroid treatment);\n14. It is known that there is an active autoimmune disease requiring symptomatic treatment or a history of the disease within the past 2 years (patients with vitiligo, psoriasis, alopecia or Graves' disease that do not require systemic treatment in the past 2 years, hypothyroidism who only need thyroid hormone replacement therapy, and type 1 diabetes who only need insulin replacement therapy can be enrolled).\n15. Female patients who are pregnant or breastfeeding;\n16. Any serious or uncontrolled systemic disease that researchers believe may increase the risk of participation in patients",{"count":7,"type":21},[76],"This study is a single-arm clinical trial to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab combined with chemotherapy in the first-line treatment of patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC). After screening and meeting the inclusion criteria, the patients were enrolled and received 6 cycles of Iparomlimab and Tuvonralimab combined with albumin-bound paclitaxel and cisplatin. Subsequently, maintenance treatment was carried out using Iparomlimab and Tuvonralimab ± albumin-bound paclitaxel until disease progression or the occurrence of unacceptable adverse events, with a total maximum treatment duration of 24 months.\n\nThe main objective of this study is to: 1. evaluate the ORR of Iparomlimab and Tuvonralimab combined with albumin-bound paclitaxel and cisplatin. 2. The secondary endpoints include PFS, DCR, DoR, OS and safety, etc.",[26],[185,156,556,28],"PD-1\u002FCTLA-4","2025-12-04",{"date":559,"type":36},"2025-12-17",{"date":392,"type":36},{"date":562,"type":21},"2028-06",{"name":564,"class":43},"Hebei Medical University Fourth Hospital",{"id":566,"slug":4,"hasResults":11,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":571,"targetDuration":4,"studyType":74,"phases":573,"briefSummary":574,"conditions":575,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":577,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":4},"100613876","NCT07272291","A Phase II Study of Toripalimab Plus Chemotherapy and Low-Dose Radiotherapy for Neoadjuvant Therapy-Refractory Esophageal Squamous Cell Carcinoma","A Prospective, Single-Arm Phase II Study of Toripalimab Plus Chemotherapy and Low-Dose Radiotherapy as Neoadjuvant Treatment for Neoadjuvant Therapy-Refractory Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Males and females aged ≥ 18 years;\n* Esophageal cancer staged as T1-4aN1-3M0 or T3-4aN0M0 (per AJCC 8th edition), with histologically confirmed predominant squamous cell carcinoma at initial diagnosis;\n* Subjects must complete 2 cycles of preoperative neoadjuvant immunotherapy combined with chemotherapy (any regimen) before enrollment, followed by imaging assessment showing stable disease (SD);\n* ECOG performance status score of 0 or 1;\n* All required baseline laboratory tests must be completed, with results obtained within 14 days before enrollment. Laboratory tests resluts must meet the following criteria (per CTCAE v5):\n\nWBC ≥ 2000\u002FμL Neutrophils ≥ 1500\u002FμL Platelets ≥ 100 × 10³\u002FμL Hemoglobin ≥ 9.0 g\u002FdL Creatinine: Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance \\> 50 mL\u002Fmin (per Cockcroft\u002FGault formula) AST ≤ 3 × ULN, ALT ≤ 3 × ULN Total bilirubin ≤ 1.5 × ULN (except subjects with Gilbert syndrome, for whom total bilirubin must be \\\u003C 3 × ULN);\n\n* Tumor tissue and blood must be provided for biomarker analysis. If the provided tumor tissue is insufficient for analysis, additional archived tumor tissue (blocks and\u002For sections) must be obtained;\n* Subjects voluntarily participate in the study, sign a written informed consent form, and are compliant with follow-up;\n* Subjects must be willing and able to adhere to scheduled visits, treatment plans, laboratory tests, tumor biopsies, and other study requirements;\n* Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days before enrollment, and agree to use effective contraception during the study and for at least 6 months after the last dose of toripalimab. Males with partners of childbearing potential must agree to use effective contraception during the study and for at least 6 months after the last dose.\n\nExclusion Criteria:\n\n* Subjects with a history of other malignant tumors are excluded, unless complete remission was achieved at least 5 years prior to study entry and no additional treatment is required or anticipated during the study period. Exceptions include, but are not limited to, basal or squamous cell carcinoma of the skin, superficial bladder cancer, or in situ carcinoma of the prostate, cervix, or breast.\n* Subjects with known or suspected active autoimmune diseases are excluded. However, enrollment is permitted for subjects with type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, cutaneous conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or conditions not expected to recur in the absence of external triggers.\n* Subjects who required systemic treatment with corticosteroids (\\>10 mg daily prednisone equivalent) or other immunosuppressive agents within 14 days prior to study drug administration are excluded. Inhaled or topical steroids, as well as adrenal replacement steroids, at doses exceeding 10 mg daily prednisone equivalent are allowed only in the absence of active autoimmune disease.\n* Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity are excluded.\n* All toxicities attributable to prior anticancer therapy (except nephropathy, neuropathy, hearing loss, alopecia, and fatigue) must resolve to Grade 1 (per NCI CTCAE Version 5) or baseline before study drug administration. Subjects with toxicities from prior anticancer therapy that are not expected to resolve and result in permanent sequelae (e.g., peripheral neuropathy following platinum-based therapy) are permitted, provided the peripheral neuropathy resolves to Grade 2 (per NCI CTCAE Version 5).\n* Subjects with any severe or uncontrolled medical condition or active infection that, in the investigator's judgment, may increase the risks of study participation or study drug administration, or impair the subject's ability to complete treatment per the protocol are excluded.\n* Subjects with a known positive human immunodeficiency virus (HIV) test result or a confirmed diagnosis of acquired immunodeficiency syndrome (AIDS) are excluded.\n* Subjects who received live\u002Fattenuated vaccines within 30 days prior to the first study treatment are excluded.\n* Subjects with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection are excluded, including those with: acute or chronic active hepatitis B\u002F C; HBV DNA \\>2000 IU\u002FmL or 10⁴ copies\u002FmL; HCV RNA \\>10³ copies\u002FmL; or concurrent positivity for hepatitis B surface antigen (HBsAg) and anti-HCV antibodies.\n* Subjects with a history of allergy or hypersensitivity to any component of the study drug, or a history of severe hypersensitivity to any monoclonal antibody are excluded.\n* Subjects currently participating in other interventional clinical studies are excluded.",{"count":572,"type":21},48,[76],"The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant toripalimab combined with chemotherapy and low-dose radiotherapy in patients with esophageal squamous cell carcinoma who are insensitive to neoadjuvant therapy. The main question it aims to answer is:\n\n• Whether adding low dose radiotherapy can improve the efficacy of immunotherapy combined chemotherapy in neoadjuvant setting?\n\nParticipants will receive low-dose radiotherapy (1.2 Gy\u002Ffraction, 5 fractions), followed by 2 cycles of chemotherapy plus toripalimab (240 mg, q3w). 6 to 8 weeks after treatment completion, a systematic preoperative assessment is conducted, then surgery is performed. Postoperatively, management depends on pathological results:\n\nNon-pathological complete response (non-pCR) patients: Toripalimab monotherapy continues until disease recurrence, intolerable toxicity, informed consent withdrawal, or for 1 year (whichever comes first).\n\nPathological complete response (pCR) patients: Directly undergo regular postoperative survival follow-up",[26],"2025-11-26",{"date":578,"type":36},"2025-12-09",{"date":580,"type":21},"2025-12-25",{"date":582,"type":21},"2028-12-25",{"name":584,"class":43},"Tianjin Medical University Cancer Institute and Hospital",{"id":586,"slug":4,"hasResults":11,"nctId":587,"briefTitle":588,"officialTitle":588,"acronym":589,"eligibilityCriteria":590,"healthyVolunteers":591,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":594,"conditions":595,"keywords":601,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":612,"locationsCount":44},"100610220","NCT07224750","A Noninvasive and Screening miRNA Signature for Gastrointestinal Cancer","MiGIC","Inclusion Criteria:\n\n1. Adults aged 18 years or older at the time of blood sample collection.\n2. Patients with a confirmed diagnosis of one of the following gastrointestinal cancers: Hepatocellular carcinoma (HCC), Cholangiocarcinoma (CCA), Pancreatic ductal adenocarcinoma (PDAC), Esophageal squamous cell carcinoma (ESCC), Gastric cancer (GC), Colorectal cancer (CRC), Non-cancer control participants, including healthy volunteers or patients with benign gastrointestinal conditions.\n3. Availability of retrospective blood samples collected according to institutional protocols.\n4. Willingness to allow use of de-identified clinical and demographic data for research purposes.\n\nExclusion Criteria:\n\n* other active malignancies; insufficient sample quality\u002Fvolume; recent chemotherapy\u002Fradiotherapy\u002Fsurgery; any condition preventing reliable participation.",true,{"count":593,"type":21},1000,"Gastrointestinal (GI) cancers remain a major global health burden, largely due to the lack of effective and accessible early screening strategies. Current diagnostic approaches-including endoscopy, computed tomography (CT), and magnetic resonance imaging (MRI)-are either invasive, resource-intensive, or insufficiently sensitive for detecting early-stage disease, and are therefore not suitable for population-wide screening or for simultaneously identifying multiple GI tumor types. As a result, many patients are diagnosed at advanced stages, when therapeutic options are limited and prognosis is poor.\n\nCirculating microRNAs (miRNAs) offer a promising alternative, as they are stable in peripheral blood and reflect tumor-related molecular alterations. In this study, the investigators aim to develop and validate a robust, noninvasive miRNA-based signature capable of distinguishing GI cancers from non-malignant controls. By integrating multi-cohort datasets and applying machine learning-based feature selection and predictive modeling, the investigators will construct a screening panel optimized for reproducibility, scalability, and early-stage detection. This noninvasive miRNA signature has the potential to support accessible, cost-effective, and clinically practical population-level screening for GI cancers, ultimately facilitating earlier diagnosis and improving outcomes for participants.",[596,597,598,26,599,600],"Hepatocellular Carcinoma (HCC)","Cholangiocarcinoma","Pancreatic Ductal Adenocarcinoma (PDAC)","Gastric Cancer (GC)","Colorectal Cancer Screening",[602,603,604,605,606],"Noninvasive screening","Circulating miRNA","Machine learning","Gastrointestinal cancer","Blood-based cancer detection","2025-11-24",{"date":576,"type":36},{"date":610,"type":36},"2024-06-21",{"date":110,"type":21},{"name":613,"class":43},"City of Hope Medical Center",{"id":615,"slug":4,"hasResults":11,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":4,"eligibilityCriteria":619,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":620,"targetDuration":4,"studyType":74,"phases":622,"briefSummary":623,"conditions":624,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":4},"100611880","NCT07246330","Stratified Treatment in Unresectable Locally Advanced ESCC Without Progression After Chemoimmunotherapy Induction Plus CCRT: Toripalimab Consolidation vs observation--a Prospective, Randomized, Controlled Phase III Multicenter Study","Stratified Treatment in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma Without Progression After Chemoimmunotherapy Induction Plus Concurrent Chemoradiotherapy: Toripalimab Consolidation vs observation--a Prospective, Randomized, Controlled Phase III Multicenter Study","Inclusion Criteria:\n\n1. Patients voluntarily participate in this study, signed informed consent, good compliance with follow-up;\n2. Aged 18-75 years (inclusive), male or female;\n3. Clinically staged II-IVa unresectable (AJCC 8th ed.: cT1N2-3M0\u002FcT2-4bN0-3M0) or IVb (supraclavicular lymph node metastasis only); the patient had no disease progression after 2-4 cycles of chemo-immunotherapy induction combined with concurrent chemoradiotherapy (CCRT). Patients receiving CCRT must meet the following criteria: Patients with inoperable tumors must have received at least 2 cycles of weekly regimen or 1 cycle of 3-week platinum-based chemotherapy combined with radical radiotherapy (50-64 Gy) and have no evidence of radiographic disease progression (according to RECISTv1.1) as compared to before and after radical concurrent chemoradiation;\n4. ECOG PS 0-1;\n5. Expected survival ≥3 months;\n6. Fresh or archived tumor tissue samples within 6 months should be provided for biomarker analysis. The sample type is FFPE tumor tissue block or at least 10 unstained FFPE tumor tissue sections with a thickness of 3-5 μm. For patients who cannot provide tissue samples meeting the above requirements, the investigator should discuss and determine whether to enroll;\n7. Adequate organ and bone marrow function defined as:\n\n   1. ANC ≥1.5×10⁹\u002FL;\n   2. Platelets ≥100×10⁹\u002FL;\n   3. Hemoglobin ≥9g\u002FdL;\n   4. Serum albumin ≥2.8g\u002FdL;\n   5. Total bilirubin ≤1.5×ULN; ALT\u002FAST\u002FAKP ≤2.5×ULN;\n   6. Serum creatinine ≤1.5×ULN or creatinine clearance ≥60mL\u002Fmin (Cockcroft-Gault);\n   7. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN \\[Patients receiving stable-dose anticoagulant therapy (e.g., low-molecular-weight heparin or warfarin) with an INR within the expected therapeutic range of the anticoagulant are eligible\\];\n8. Females of childbearing potential: negative pregnancy test within 72h pre-first dose; contraception during study + 6 months post-last dose. Males with fertile partners: contraception during study + 6 months post-last dose.\n\nExclusion Criteria:\n\n1. Any unresolved NCI CTCAE ≥ grade 2 toxicity following prior chemoradiotherapy. Patients with irreversible and controllable hearing loss are eligible;\n2. Small cell carcinoma, adenocarcinoma, or mixed carcinoma components in histology;\n3. Grade ≥ 2 peripheral neuropathy based on NCI CTCAEv5.0 criteria\n4. Found to have a higher risk of esophageal fistula by clinical assessment or imaging studies, such as a past history or related symptoms of esophageal fistula, or infiltration of the primary tumor into the great vessels or trachea;\n5. Patients with any history of active autoimmune diseases or autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); patients without any intervention after adults except vitiligo or recovered childhood asthma\u002Fallergy; patients with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone and type I diabetes treated with stable doses of insulin can be included;\n6. History of immunodeficiency, including positive HIV test, or other acquired, congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation;\n7. Patients with uncontrolled cardiac clinical symptoms or diseases, such as (1) NYHA II and above heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention;\n8. Serious infection (CTCAE \\> grade 2) within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; baseline chest imaging showed active pulmonary inflammation, symptoms and signs of infection within 2 weeks before the first use of the study drug need oral or intravenous antibiotics, but excluding the prophylactic use of antibiotics; through the history or CT examination found active pulmonary tuberculosis infection, or within 1 year before enrollment found active pulmonary tuberculosis infection history, or more than 1 year ago had active pulmonary tuberculosis infection history but no regular treatment of patients;\n9. Known allergies, hypersensitivity, or contraindications to terdiplimumab or any of the components used in its formulation;\n10. Diagnosis of any other malignancy before the first use of study drugs, except for those with a low risk of metastasis and death (5-year survival rate \\> 90%), such as adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ;\n11. Pregnant or lactating women; fertile subjects are unwilling or unable to take effective contraceptive measures;\n12. According to the investigator 's judgment, the patient has other factors that may cause the patient to be forced to terminate the study halfway, such as suffering from other serious diseases (including mental illness) requiring concomitant treatment, and recently combined with other serious diseases (such as myocardial infarction, cerebrovascular accident) considering the high risk of recurrence, severely abnormal laboratory test values, family or social factors, which may affect the patient' s safety or the collection of trial data.",{"count":621,"type":21},340,[152],"This study is a prospective, randomized controlled, phase III multicenter trial. Its objectives are to explore the stratified application of consolidation immunotherapy after chemoimmunotherapy induction plus concurrent chemoradiotherapy, identify the potential beneficiary population of consolidation immunotherapy, and evaluate the efficacy and safety of consolidation immunotherapy.\n\nThe main participants are patients with unresectable locally advanced esophageal squamous cell carcinoma who have undergone 2-4 cycles of chemoimmunotherapy induction followed by concurrent chemoradiotherapy. Imaging assessment should be completed within 1-84 days after the end of chemoradiotherapy. Eligible patients meeting the inclusion and exclusion criteria will be divided into the CR\u002FPR cohort and SD cohort based on treatment response, and receive the following treatments respectively:\n\nCR\u002FPR cohort: Patients with a response assessment of CR (Complete Response) or PR (Partial Response) will be randomly assigned at a 1:1 ratio to:\n\nToripalimab monotherapy maintenance group (Group A1) vs. Observation group (Group A2) (116 patients vs. 116 patients)\n\nSD cohort: Patients with a response assessment of SD (Stable Disease) will be randomly assigned at a 1:1 ratio to:\n\nToripalimab monotherapy maintenance group (Group B1) vs. Observation group (Group B2) (54 patients vs. 54 patients) The medication dosage is as follows: Toripalimab 240mg, intravenous infusion on Day 1, every 3 weeks (Q3W). A total of 3 treatment cycles will be administered. Subsequent treatment continuation will be determined by the patient. If continued, treatment will proceed until the occurrence of disease progression (radiological progression confirmed by RECIST v1.1), intolerable toxicity, initiation of new antitumor therapy, voluntary withdrawal of the subject from the study, or the investigator's judgment that the subject needs to withdraw. The maximum duration of medication is 1 year.",[26],"2025-11-17",{"date":607,"type":36},{"date":628,"type":21},"2025-12-15",{"date":630,"type":21},"2029-12-15",{"name":584,"class":43},{"id":633,"slug":4,"hasResults":11,"nctId":634,"briefTitle":635,"officialTitle":636,"acronym":4,"eligibilityCriteria":637,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":450,"enrollmentInfo":638,"targetDuration":4,"studyType":74,"phases":640,"briefSummary":641,"conditions":642,"keywords":643,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":44},"100586184","NCT06912074","Hypofractionated vs. Conventional Chemoradiotherapy After Induction Chemo-immunotherapy for Unresectable Esophageal Squamous Cell Carcinoma","Comparing Hypofractionated Concurrent Chemoradiotherapy Versus Conventional Fractionated Concurrent Chemoradiotherapy Following Induction Chemo-immunotherapy in Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Prospective, Open-Label, Randomized Phase II Clinical Trial","Inclusion Criteria:\n\n* Pathologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma;\n* Evaluated as unresectable locally advanced esophageal squamous cell carcinoma by endoscopic ultrasound, imaging studies including esophagography, CT of the neck, chest, and upper abdomen, MRI of the neck and chest, whole-body bone scan, or PET\u002FCT, with staging in the range of II-IVB (stage IVB limited to celiac lymph node or supraclavicular lymph node metastasis);\n* Male or female aged 18 to 80 years;\n* Eligible for oral drug therapy;\n* No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy;\n* Tumor sample requirement: Must provide adequate unstained, archived tumor tissue samples for analysis;\n* Expected survival ≥12 weeks;\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;\n* Postmenopausal women, or women with a negative urine or serum pregnancy test within 14 days before the study drug administration;\n* Women must not be breastfeeding;\n* Organ and bone marrow function must meet the following criteria: Forced expiratory volume in 1 second (FEV1) ≥1000 mL; Absolute neutrophil count ≥1.5 × 10\\^9\u002FL; Platelets ≥100 × 10\\^9\u002FL; Hemoglobin ≥90 g\u002FL; Estimated glomerular filtration rate (eGFR) ≥50 mL\u002Fmin based on the Cockcroft-Gault formula (Cockcroft and Gault, 1976); Serum bilirubin ≤1.5 × the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN;\n* Signed and dated informed consent must be provided before participation in any study procedures.\n\nExclusion Criteria:\n\nExclusion Criteria for Induction Treatment:\n\n* Participation in another clinical trial, unless it is an observational (non-interventional) study;\n* Use of immunosuppressive drugs within 28 days prior to the first infusion of Toripalimab, excluding physiological doses of intranasal inhaled corticosteroids, prednisone ≤10 mg\u002Fday, or equivalent systemic corticosteroids;\n* Prior use of any anti-PD-1 or anti-PD-L1 antibody;\n* Major surgery within 4 weeks prior to entering the study (excluding vascular access procedures);\n* A history of autoimmune disease within the past 2 years;\n* Active or a history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis);\n* History of primary immunodeficiency;\n* History of organ transplantation requiring immunosuppressive treatment;\n* Uncontrolled complications, including but not limited to persistent or active infections, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, arrhythmias, active peptic ulcer disease or gastritis, active bleeding disorders, including any known HBsAg-positive patients with HBV DNA \\>500 IU\u002Fml, hepatitis C, or HIV, or any psychiatric or social conditions that would impair the ability to comply with study requirements or harm the patient's ability to provide written informed consent;\n* Receipt of a live attenuated vaccine within 30 days prior to study initiation or within 30 days after receiving Toripalimab;\n* History of another primary malignancy within 5 years prior to the initiation of Toripalimab treatment, excluding adequately treated skin basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix;\n* Pregnancy, breastfeeding women, or men and women of reproductive potential who are not using effective contraception.\n\nExclusion Criteria for Concurrent Chemoradiotherapy After Induction Treatment:\n\n* Development of distant metastasis (excluding celiac lymph node or supraclavicular lymph node metastasis);\n* Development of local regional progression, with the radiation oncologist assessing that the patient cannot receive definitive chemoradiotherapy due to normal tissue dose limitations;\n* PS score of 2-4;\n* Any of the following organ and bone marrow dysfunction criteria: FEV1 \\\u003C1000 mL; absolute neutrophil count \\\u003C1.5 × 10\\^9\u002FL; platelets \\\u003C100 × 10\\^9\u002FL; hemoglobin \\\u003C90 g\u002FL; serum creatinine clearance \\\u003C50 mL\u002Fmin according to the Cockcroft-Gault formula (Cockcroft \\& Gault, 1976); serum bilirubin \\>1.5 times the upper limit of normal (ULN); ALT and AST \\>2.5 times ULN.",{"count":639,"type":21},134,[76],"This is a prospective, open-label, randomized phase II clinical trial designed to compare the efficacy and toxicity of hypofractionated concurrent chemoradiotherapy versus conventional fractionated concurrent chemoradiotherapy following induction chemoimmunotherapy in patients with unresectable locally advanced esophageal squamous cell carcinoma.",[26],[28,644,645,646],"Hypofractionated Concurrent Chemoradiotherapy","Conventional Fractionated Concurrent Chemoradiotherapy","Induction chemoimmunotherapy","2025-11-13",{"date":625,"type":36},{"date":650,"type":36},"2025-04-05",{"date":652,"type":21},"2029-04-04",{"name":142,"class":43},""]