[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colorectal-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colorectal-neoplasms":738},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,102,0,25,[9,46,79,110,139,160,195,233,258,290,338,362,400,425,444,464,483,508,533,566,588,615,641,663,711],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100573826",false,"NCT06751329","A Study of DM002 in Patients With Advanced Solid Tumors","A Phase I\u002FIIa, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM002 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\nCommon Inclusion Criteria (Part 1 and Part 2)\n\n1. Subjects must have the ability to understand and willingness to sign a written informed consent document.\n2. Subjects must be ≥18 years of age at the time of signing the informed consent form.\n3. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n4. Has a life expectancy of ≥3 months.\n5. Participants must meet the following laboratory values within 7 days prior to first dose of study drug:\n\n   Note: Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 2 weeks prior to laboratory assessments at Screening.\n   * Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL;\n   * Platelet count ≥100 × 10⁹\u002FL;\n   * Hemoglobin ≥9 g\u002FdL;\n   * Calculated creatinine clearance (CrCL) \\>60 mL\u002Fmin (Cockroft-Gault Equation);\n   * Total bilirubin ≤ 1.5 x ULN;\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × upper limit of normal (ULN), if liver metastases are present, ≤5 × ULN;\n   * International normalized ratio (INR)\\\u003C2.0, and prothrombin time and either partial thromboplastin time (PTT) or activated PTT (aPTT) ≤1.5 × ULN, except for participants receiving anti-vitamin K derivative anticoagulant therapy who must have prothrombin time\u002FINR within therapeutic range as deemed appropriate by the Investigator.\n6. Has measurable disease based on RECIST version 1.1.\n7. Participants are required to provide tumor tissue specimens obtained within the previous 3 years for the measurement of MUC1 and\u002For HER3 and other biomarkers. For those subjects who are unable to provide tissue samples will be encouraged (but not mandatory) to undergo biopsy if the risk is manageable. If the biopsy is not possible, it should inform the sponsor for enrolment.\n\nExclusion Criteria:\n\n1. Subjects have another active invasive malignancy within 5 years, with the following exceptions and notes:\n\n   1. History of noninvasive malignancy, such as cervical cancer in situ, in situ melanoma, or ductal carcinoma in situ of the breast that is in complete remission 5 years after treatment with curative intent is allowed.\n   2. Malignancies with a negligible risk of metastasis or death (such as adequately treated basal or squamous cell skin cancer and localized prostate cancer).\n2. Current or history of a hematologic malignancy.\n3. Anticancer therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or other anti-cancer therapies, except for hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogs, agonists required to suppress serum testosterone levels) within 28 days or 5 half-lives, whichever is shorter, prior to the first study dose. Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with a limited field of radiation for palliation within 14 days of the first study dose. Major surgery, other than diagnostic surgery, within 4 weeks of the first study dose.\n4. Primary central nervous system (CNS) malignancies or CNS metastases. Individuals with brain metastases can be enrolled only if treated, nonprogressive brain metastases and off high-dose steroids (\\>20 mg prednisone or equivalent) for at least 4 weeks.\n5. History of known allergies to ADC, or prior discontinuation of an ADC due to treatment-related toxicities. Has received prior treatment with ADCs that include topoisomerase I (Topo I) payload, and treatment history with any investigational drug within 4 weeks before enrolment in the study.\n6. Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals.\n7. Has a pre-existing clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or pre-existing ocular disorders.\n8. Clinically uncontrolled intercurrent illness, including but not limited to an ongoing active infection, active coagulopathy, uncontrolled cardiovascular disease, uncontrolled immune disease, uncontrolled diabetes, uncontrolled pleural and peritoneal effusion, psychiatric illness that would limit compliance with the study requirements and other serious medical illnesses requiring systemic therapies.\n9. Mean resting corrected QT interval corrected by Fridericia's formula (QTcF) \\>470 msec obtained from triplicate 12-lead ECGs at baseline; using concomitant medications that would prolong the QT interval.\n10. Left ventricular ejection fraction \\\u003C50% by either an echocardiogram (ECHO) or a multi-gated acquisition scan within 28 days before first dose of the study drug.\n11. Known active hepatitis B (HBV) or hepatitis C (HCV) infection. Chronic carriers of HBV infection (HBsAg-positive, undetectable HBV DNA or HBV DNA ≤2500 copies\u002Fml or 500 IU\u002Fml) receive prophylactic treatment during the study can be enrolled. Participants with a history of HCV infection have completed curative antiviral treatment and HCV viral load below the limit of quantification and HCV antibody positive but HCV ribonucleic acid (RNA) negative due to prior treatment or natural resolution should be eligible.\n12. Known human immunodeficiency virus (HIV) infection which is not well controlled. Participants should be tested for HIV prior to enrollment if required by local regulations or institutional review board (IRB)\u002Fethics committee. All the following criteria are required to define an HIV infection (positive HIV1\u002F2 antibodies test) that is well controlled: HIV viral load \\\u003C400 copies\u002FmL, CD4+ T- cell counts ≥350 cells\u002FμL, no history of acquired immunodeficiency syndrome-defining opportunistic infection within the past 12 months, and stable viral load for at least 4 weeks on same anti-HIV retroviral medications.\n13. Subjects who are from endemic areas (refer to WHO high tuberculosis burden country list, China is endemic area) will be specifically screened for tuberculosis with any available test. Subjects with active tuberculosis are excluded. Subjects who have received bacille Calmette-Guerin vaccination may have a false positive result of purified-protein derivative (PPD) test. These subjects are eligible if they have a negative result of interferon gamma release assay (IGRA).\n14. Has received a live vaccine within 30 days prior to the first dose of study drug.\n15. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and anemia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, ≤Grade 1 or baseline. Note: Participants may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to \\>Grade 2 for at least 3 months prior to enrolment\u002Frandomization and managed with the standard treatment) that the Investigator deems related to previous anticancer therapy, following discussion with the Sponsor's medical monitor, such as the following: Grade 2 chemotherapy-induced neuropathy, hypothyroidism, hyperglycemia.\n16. Females who are pregnant or lactating or who intend to become pregnant during participation in the study are not eligible to participate.\n17. Participants who are of reproductive potential refuse to use effective methods of birth control during participation of the study and within 7 months for female (and 4 months for male) after the last dose administration.\n18. Participants who took drugs or food which can strongly inhibit or induce the cytochrome P450 (CYP) isoenzyme, CYP3A4\u002F5 within 2 weeks prior to the first dose of DM002 or within 5 half-lives, whichever is longer.","ALL","18 Years",{"count":19,"type":20},280,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The goal of study：\n\nThe study has two parts: Part 1 Dose Escalation and Part 2 Dose Expansion.\n\nIn Part 1, a few participants will receive the lowest dose of study drug. The study team will make sure it is safe and tolerated before enrolling new participants at a higher dose of study drug. There will be up to six or more dose levels of study drug tested (called cohorts). Which dose you receive will depend on how many participants have taken part in the study before you.\n\nThe purpose of Part 1 of the study is to evaluate the safety of the study drug at different dose levels, to understand what your body does to the study drug, and to find the best dose of study drug in people who have advanced solid tumor cancers.\n\nIn Part 2, participants will receive the best dose level that was determined in Part 1 of the study.\n\nThe purpose of Part 2 of the study is to evaluate the safety of the study drug at the dose level determined in Part 1, to understand what your body does to the study drug, and to see how your cancer responds to the study drug.\n\nParticipants will:\n\nParticipants will have 17 or more visits to the study centre. This study has a screening phase of up to 28 days , and a treatment phase with cycles of 21 days each. Participants will also have an End of Treatment (EOT) visit 21 days after the final study drug treatment, and a Follow-up visit 30 days after the EOT visit . Participants will be contacted by telephone every 3 months after the Follow-up visit to check on the wellbeing and record any new anticancer therapy they may have started.",[27,28,29,30,31,32],"Ovarian Neoplasms","Prostatic Neoplasms","Endometrial Neoplasms","Colorectal Neoplasms","Solid Carcinoma","Pancreatic Cancer","RECRUITING","2026-07-01",{"date":36,"type":37},"2026-07-02","ACTUAL",{"date":39,"type":37},"2025-02-17",{"date":41,"type":20},"2028-04-18",{"name":43,"class":44},"Xadcera Biopharmaceutical (Suzhou) Co., Ltd.","INDUSTRY",5,{"id":47,"slug":4,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":64,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100379579","NCT04222413","Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors","First-in-Human Phase I Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors","* INCLUSION CRITERIA:\n* Adult (\\>= 18 years) subjects with:\n\n  * histologically or cytologically confirmed solid tumors (Phase IA).\n\nOR\n\n--histologically or cytologically confirmed pancreatic, colorectal, or breast cancer (Phase IB)\n\nOR\n\n* Pediatric (\\>=12 and \\\u003C 18 years) subjects with histologically or cytologically confirmed solid tumors other than rhabdomyosarcoma (RMS) including embryonal, alveolar, spindle cell\u002Fsclerosing and pleomorphic subtypes of RMS (Phase IB).\n* Subjects must have disease that:\n\n  * is not amenable to potentially curative resection,\n  * spread at least to one other organ system other than primary tumor or recurred after removal of primary tumor\n  * has site measurable per RECIST 1.1\n  * progressed on or after at least one line of standard systemic chemotherapy (Phase IA and IB1)\n  * have no standard therapy option available (Phase IB2)\n* Patients must have recovered from any acute toxicity related to prior therapy or surgery or disease to a grade 1 or less.\n* Performance status\n\n  --Karnofsky \\>= 70% (for patients \\>= 16 years old), Lansky \\>= 70% (for patients \\\u003C16 years old)\n* Adequate hematological function defined by:\n\n  * absolute neutrophil count (ANC) \\>= 1.0 x 10(9)\u002FL,\n  * transfusion-independent platelet count \\>= 100 x 10(9)\u002FL,\n  * Hgb \\>= 9 g\u002F dL (patients who have received \\\u003C= 2 PRBC transfusions within 48 hours are eligible)\n* Adequate coagulation as defined by:\n\n  --INR\\\u003C1.5 (or \\\u003C 3.0 if subjects are currently taking anticoagulated medications) Note: increase of the upper limit of INR is restricted only to subjects who are receiving anticoagulation for medical reasons (DVT\u002FPE prophylaxis, treatment for a thromboembolic event) and have increased INR because of these medications. Patients who have an elevated INR due to compromised liver function or any other medical conditions remain excluded\n* Adequate hepatic function defined by:\n\n  * a total bilirubin level \\\u003C= 1.5 x ULN, (total bilirubin \\\u003C= 2.0 x ULN in case of prior diagnosis of Gilbert syndrome)\n  * an AST level \\\u003C= 3xULN\n  * an ALT level \\\u003C= 3 xULN\n* Adequate renal function defined by:\n\n  * Creatinine OR Measured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl)\n\n    ---\\\u003C 1.5x institution upper limit of normal OR\n\n    ---\\>= 45 mL\u002Fmin\u002F1.73 m\\^2 for participant with creatinine levels \\>= 1.5 X institutional ULN\n  * Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard.\n* The effects of the study treatment on the developing human fetus are unknown; thus, individuals of childbearing potential and individuals who can father children must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior\n\nto study entry, for the duration of study therapy and up to 120 days after the last dose of the study drug.\n\n* Nursing participants must be willing to discontinue nursing at the time of the study treatment initiation.\n* Weight \\>= 35 kg.\n* Ability of subject or parent\u002Fguardian to understand and the willingness to sign a written informed consent document.\n* Subjects must have lesion(s) accessible for biopsy (other than used for measurement of disease) and be willing to undergo mandatory study biopsies (Cohort IB1 only).\n* Ability to swallow oral capsules.\n\nEXCLUSION CRITERIA:\n\n* Anticancer treatment within designated period before treatment initiation including:\n\n  * minor surgical procedure (such as biliary stenting) within 14 days. Note: if liver function tests after biliary stenting or renal function tests after ureteral stenting return to normal, within 5 days after biliary or ureteral stenting;\n  * major surgical procedure or curative radiation treatment within 28 days;\n  * palliative radiation treatment within 14 days;\n  * chemotherapy or experimental drug treatment with published half-life known to be 72 hours or less within 14 days;\n  * experimental drug treatment with unpublished or half-life greater than 72 hours within 28 days;\n  * chemotherapy regimen containing an alkylating antineoplastic agent (cyclophosphamide, chlorambucil, melphalan, or ifosfamide), alkylating-like (platinumbased chemotherapeutic drugs, platinum analogues), and non-classical alkylating agent (dacarbazine, temozolomide) within 28 days.\n* Patients receiving any medications or substances that are moderate and strong inhibitors or inducers of CYP3A4 and are not able to safely stop these medications are excluded from this study; patients must stop strong CYP3A4 inhibiting\u002Finducing medications within 5 published half-lives and moderate within 3 published half-lives prior to the treatment initiation.\n\nNote: dihydropyridine calcium - channel blockers are permitted for management of underling disease\n\n* Subjects with cardiomyopathy diagnosed within 6 months prior to treatment initiation including but not limited to the following:\n\n  * hypertrophic cardiomyopathy\n  * arrhythmogenic right ventricular cardiomyopathy\n  * abnormal ejection fraction (echocardiogram \\[ECHO\\]) \\\u003C= 53% (if a range is given then the upper value of the range will be used)\n  * previous moderate or severe impairment of left ventricular systolic function (LVEF \\\u003C45%)\n  * severe valvular heart disease\n  * atrial fibrillation with a ventricular rate \\>100 bpm on EKG at rest\n  * Fridericia's corrected QT interval (QTcF) \\>= 480 msec (adults) or \\>= 460 msec (pediatric subjects, aged 12 to \\\u003C18 years) or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome.\n* HIV, HCV, HBV positive patients on antiviral drugs are excluded due to the absence of previous experience with concurrent use of antiviral medications and the investigational drug product to be evaluated in the current study and possible for adverse pharmacokinetic and\u002For pharmacodynamic interactions.\n* Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last 3 years. Note: subjects with a history of cervical carcinoma in situ, superficial or non-invasive bladder cancer, or basal cell or squamous cell carcinoma in situ previously treated with curative intent are NOT excluded.\n* Rapidly progressive disease which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or trial procedures.\n* Subjects with central nervous system (CNS) metastases or CNS disorders known to increase possible neurotoxicity of metarrestin in case of compromised blood-brain barrier (e.g. recent stroke (\\\u003C3 months of treatment initiation), infectious causes).\n* Significant acute or chronic infections including tuberculosis with presence of clinical symptoms or physical findings.\n* Patients with a history of any seizures or increased risk of seizures on screening EEGs defined by 1) interictal epileptiform discharges, 2) temporal intermittent rhythmic delta activity (TIRDA), or 3) electrographic or clinical seizures on EEG.\n* Clinically relevant diseases (for example, inflammatory bowel disease) and \u002F or uncontrolled medical conditions, which, in the opinion of the Investigator, might impair the subject's tolerance or ability to participate in the trial.\n* Patients with previous gastric bypass, patients receiving nutrition via feeding tubes or parenterally, or patients with malabsorptive conditions (damage to the intestine from infection, inflammation, trauma, or surgery, celiac disease, Crohn's disease, chronic pancreatitis, or cystic fibrosis resulting malabsorption). Patients with refractory nausea and vomiting. Note: patients with gastric banding are allowed.\n* Pregnant individuals.","12 Years","120 Years",{"count":55,"type":20},116,[23],"Background:\n\nMetastasis is the spread of cancer from one organ to a nonadjacent organ. It causes 90% of cancer deaths. No treatment specifically prevents or reduces metastasis. Researchers hope a new drug can help. It stops cancer cells from growing and spreading further and possibly shrink cancer lesions in distant organs.\n\nObjective:\n\nTo find a safe dose of metarrestin and to see if this dose shrinks tumors.\n\nEligibility:\n\nAdults age 18 and older with pancreatic cancer, breast cancer, or a solid tumor that has not been cured by standard therapies. Also, children age 12-17 with a solid tumor (other than a muscle tumor) with no standard therapy options.\n\nDesign:\n\nParticipants will be screened with:\n\n* blood tests\n* physical exam\n* documentation of disease confirmation or tumor biopsy\n* electrocardiogram to evaluate the heart\n* review of their medicines and their ability to do their normal activities\n\nParticipants will take metarrestin by mouth until they cannot tolerate it or stop to benefit from it. They will keep a medicine diary.\n\nParticipants will visit the Clinical Center. During the first month there are two brief hospital stays required with visits weekly or every other week thereafter. They will repeat some of the screening tests. They will fill out questionnaires. They will have tests of their cognitive function. They will have an electroencephalogram to record brain activity. They will have a computed tomography (CT) scan or magnetic resonance imaging (MRI). A CT is a series of X-rays of the body. An MRI uses magnets and radio waves to take pictures of the body.\n\nAdult participants may have tumor biopsies.\n\nParticipants will have a follow-up visit 30 days after treatment ends. Then they will have follow-up phone calls or emails every 6 months for the rest of their life or until the study ends.\n\n...",[59,60,61,62,63,30],"Advanced Solid Tumors","Metastatic Pancreatic Cancer","Pediatric Solid Tumor","Advanced Breast Cancer","Malignant Peripheral Nerve Sheath Tumor",[65,66,67,68,69],"First-In-Class Investigational Agent","Peri-Nucleolar Compartment (PNC)","effective therapies against metastasis","Oral Administration","Maximum Recommended Starting Dose",{"date":36,"type":37},{"date":72,"type":37},"2020-10-27",{"date":74,"type":20},"2028-12-31",{"name":76,"class":77},"National Cancer Institute (NCI)","NIH",2,{"id":80,"slug":4,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":16,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":21,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":104,"leadSponsor":106,"locationsCount":109},"100598435","NCT07071454","Preventing Early-Onset Colorectal Cancer in the VA","Preventing Early-Onset Colorectal Cancer in the VA Using a Multilevel Screening Intervention","PRECISE","Inclusion Criteria:\n\n* Age 45-49 years at screening\n\nExclusion Criteria:\n\n* Up-to-date with CRC screening based on the USPSTF guideline (e.g., colonoscopy within the past 10 years or FIT within the past year)\n* Prior CRC diagnosis\n* Prior total colectomy\n* Limited life expectancy (defined as terminal illness, hospice enrollment, or documented life expectancy \\\u003C6 months on the medical problem list or a health factor in the EHR\n* Deactivated national CRC screening and surveillance reminder (due to risk level or comorbidities)",true,"45 Years","49 Years",{"count":90,"type":20},536,[92],"NA","Colorectal cancer is a leading cause of cancer death among Veterans. The starting age for colorectal cancer screening has been lowered from 50 to 45 years in response to the rising incidence of early-onset colorectal cancer (EOCRC), but how to best engage younger Veterans in screening is unclear. The investigators will 1) develop and validate a novel risk score for EOCRC derived from the VA electronic health record data, 2) conduct a multilevel screening intervention that targets individuals aged 45-49 years and informs high-risk individuals and their providers about their risk status for EOCRC, and 3) determine barriers and facilitators to implementing the intervention using a qualitative process evaluation. Aim 2 is the focus of the trial. The overall goal of this study is to create and test a risk stratification approach to prevent EOCRC, which may be especially useful for younger individuals who are less likely to participate in preventive care.",[30,95],"Mass Screening",[97,98,99],"early onset colorectal cancer","risk stratification","behavioral intervention","NOT_YET_RECRUITING","2026-06-29",{"date":34,"type":37},{"date":34,"type":20},{"date":105,"type":20},"2029-06-30",{"name":107,"class":108},"VA Office of Research and Development","FED",1,{"id":111,"slug":4,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":21,"phases":119,"briefSummary":120,"conditions":121,"keywords":127,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"100601754","NCT07114601","A Study of LY4257496 in Participants With Cancer (OMNIRAY)","A Phase 1a\u002Fb Multicenter, Open-Label Trial to Evaluate Safety, Tolerability, and Dosimetry of LY4257496, a GRPR-Targeted Radioligand Therapy, in Adults With GRPR-Positive Advanced Solid Tumors (OMNIRAY)","OMNIRAY","Inclusion Criteria:\n\n* Must have histologically or cytologically proven diagnosis of locally advanced, unresectable, or metastatic cancer.\n* Must be assessed by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) to confirm at least 1 of the following:\n\n  * At least 1 measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n  * If only bone lesions are present without a soft-tissue component, a bone scan or MRI must confirm at least 2 detectable lesions considered to represent active metastases\n* Must have GRPR-positive disease, defined by investigator assessment of GRPR imaging.\n* Must have the following histologically or cytologically confirmed diagnosis:\n\n  * Estrogen receptor (ER+)\u002Fhuman epidermal growth factor receptor 2 (HER2-) breast cancer\n  * ER+\u002FHER2+ breast cancer\n  * Esophageal squamous cell carcinoma\n  * Adenocarcinoma of the stomach, gastroesophageal junction, or esophagus\n  * Colorectal carcinoma\n  * Metastatic castration-resistant prostate cancer\n  * Endometrial carcinoma. Carcinosarcoma is eligible. Uterine leiomyosarcoma, adenosarcoma, or endometrial stromal sarcoma is not eligible.\n  * Low-grade papillary serous ovarian cancer\n  * Other non-Central Nervous System (CNS) primary GRPR-positive solid tumors (Cohorts A1 dose escalation and D1 dose expansion only)\n* For participants with breast cancer diagnosis, where possible, ER and HER2 status should be assessed from the most recent tissue biopsy taken at the time of presentation with recurrent or metastatic disease.\n\n  * To fulfill the requirement for ER+ disease by local testing, a tumor must express the ER immunohistochemistry, as defined in the relevant American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines.\n  * HER2 status should be determined by local testing, as defined in the relevant ASCO\u002FCAP Guidelines.\n* Must have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1.\n* Must be able to comply with outpatient treatment, laboratory monitoring, imaging, and required clinic visits for the duration of trial participation.\n\nExclusion Criteria:\n\n* Phase 1a (Cohort A1 and A2) only: Previously received radiopharmaceutical or radioligand therapy. For participants with prostate cancer, prior ¹⁷⁷Lu-prostate-specific membrane antigen (PSMA) is permitted.\n* Has a history of ongoing acute pancreatitis within 1 year of screening.\n* Previously received any prior hemi-body or whole-body radiotherapy, or prior external beam radiation therapy (EBRT) to greater than 25% of the bone marrow.\n* A bone superscan, defined as a bone scan that demonstrates markedly increased skeletal radioisotope uptake relative to soft tissues in association with absent or faint genitourinary tract activity.\n* Has evidence of ongoing and untreated urinary tract obstruction or unmanageable urinary incontinence.\n* Have known active hepatitis B virus (HBV). Exception: Individuals with chronic HBV if they:\n\n  * Have positive HBsAg\n  * Are on suppressive antiviral therapy, as allowed per local regulations prior to C1D1\n  * Remain on the same antiviral treatment throughout study, and should follow local standards for continuation of therapy after completion of trial therapy.\n  * Have undetectable HBV DNA ≤14 days of C1D1.\n* Have known active hepatitis C virus (HCV). Exception: Individuals previously treated for HCV if they:\n\n  * Completed curative antiviral therapy.\n  * Have an HCV viral load below the limit of quantification ≤14 days of C1D1 and.\n  * Are positive for anti-HCV antibodies and negative for HCV ribonucleic acid (RNA) before randomization.\n* Have untreated human immunodeficiency virus (HIV) infection. Exception: Individuals who have well-controlled HIV infection\u002Fdisease and they:\n\n  * Are on a stable and permitted antiretroviral therapy (ART) regimen without changes in drug or dose, for at least 4 weeks prior to C1D1\n  * Have a viral load of \\\u003C400 copies\u002FmL ≤14 days of C1D1.\n  * Have a CD4+ T-cell count ≥350 cells\u002FmL ≤14 days of C1D1.\n  * Have not had an opportunistic infection within the past 12 months.\n* Has an active second malignancy unless in remission with life expectancy greater than 2 years.\n* Has known hypersensitivity to any component or excipient of LY4257496.",{"count":118,"type":20},421,[23],"The main purpose of this study is to evaluate safety, tolerability, and efficacy of LY4257496 alone and as part of relevant standard of care (SOC) combination therapy in participants with Gastrin-releasing Peptide Receptor (GRPR)-positive advanced cancer, including but not limited to breast, colorectal, prostate, endometrial, esophageal, gastroesophageal (GE) junction, and gastric cancer. The study will also evaluate the safety, tolerability, and efficacy of LY4257529 to identify cancer with high levels of a protein called GRPR. This is a 2-part study. Participation could last up to 36 weeks or until your tumor progresses.",[122,30,123,29,124,125,126],"Breast Neoplasms","Prostate Neoplasm","Neoplasm Metastasis","Stomach Neoplasms","Esophageal Neoplasms",[128],"GRPR-positive","2026-06-19",{"date":131,"type":37},"2026-06-23",{"date":133,"type":37},"2025-08-06",{"date":135,"type":20},"2035-04",{"name":137,"class":44},"Eli Lilly and Company",32,{"id":140,"slug":4,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":21,"phases":147,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":159},"100567064","NCT06663319","A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers","A Phase 1 Study of JNJ-89402638 for Unresectable Metastatic Colorectal Cancer and Other Gastrointestinal Malignancies","Inclusion Criteria:\n\n* For Part 1 (dose escalation), Part 2 (Arm A \\[JNJ-89402638 monotherapy\\]): Have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma (CRC) progressing after 2 or more prior lines of standard therapy in the metastatic\u002Funresectable setting; For Part 2 Arm B (JNJ-89402638 + bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of CRC progressing after 2 or more prior lines of standard therapy in the metastatic\u002Funresectable setting; For Part 2 Arm C (JNJ-89402638 + FOLFOX\u002Fbevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of microsatellite stable (MSS) or proficient mismatch repair (pMMR) CRC progressing after 1 or more prior lines of standard therapy in the metastatic\u002Funresectable setting. Participants must have previously received a fluoropyrimidine and irinotecan doublet (such as FOLFIRI); For Part 2 Arm D (JNJ-89402638 + FOLFIRI\u002Fbevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of MSS or pMMR CRC progressing after 1 prior line of standard therapy in the metastatic\u002Funresectable setting. Must not have received irinotecan previously for metastatic disease; For Part 2 Arm E (JNJ-89402638 monotherapy in mGAC): Have histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma progressing after 1 or more prior lines of standard therapy in the metastatic\u002Funresectable setting\n* Have evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1\n\n  1. Part 1: Must have either measurable or evaluable disease\n  2. Part 2: Must have at least 1 measurable lesion\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Have an estimated or measured glomerular filtration rate (GFR) greater than or equal to (\\>=) 30 milliliter per minute (mL\u002Fmin) based on modification of diet in renal disease (MDRD) 4-variable formula\n\nExclusion Criteria:\n\n* Active (new or progressive) brain metastases, leptomeningeal disease, or untreated spinal cord compression\n* Toxicity from prior anticancer therapy that has not resolved to Grade less than or equal to (\\\u003C=)1 (except alopecia, vitiligo, Grade \\\u003C= 2 peripheral neuropathy, or endocrinopathies that are stable on hormone replacement). For Part 2 Arm C: Grade 2 or higher peripheral neuropathy is considered exclusionary\n* Has a prior or concurrent second malignancy (other than the disease under study) unless natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment\n* Received glucocorticoids (doses \\>10 mg\u002Fday prednisone or equivalent) within 7 days prior to the first dose of study drug\n* Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment or within 4 weeks after the last dose of study treatment",{"count":146,"type":20},260,[23],"The purpose of this study is to determine the putative recommended phase 2 dose(s) (RP2Ds) and best way to take (optimal route of administration) JNJ-89402638 and to determine the safety of JNJ-89402638 at the RP2D(s) in participants with metastatic colorectal cancer (mCRC) and metastatic gastric cancer (mGAC) and to determine the safety and tolerability of JNJ-89402638 in combination with bevacizumab or biosimilar with or without chemotherapy in participants with mCRC.",[30,150],"Gastrointestinal Neoplasms",{"date":152,"type":37},"2026-06-24",{"date":154,"type":37},"2024-10-15",{"date":156,"type":20},"2028-07-19",{"name":158,"class":44},"Janssen Research & Development, LLC",11,{"id":161,"slug":4,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":86,"sex":16,"minAge":166,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":21,"phases":170,"briefSummary":171,"conditions":172,"keywords":174,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":109},"100641780","NCT07628998","Impact of SMS Messaging on Participation in Colorectal Cancer Screening","Impact of SMS Notifications on the Colorectal Cancer Screening Program","Inclusion Criteria:\n\n* Women and men aged 50 to 69 years.\n* Residents of the Vallès Occidental area.\n* Individuals invited to the Colorectal Cancer Screening Program (PDPCCR) who have not participated within 5 weeks of the initial invitation.\n\nExclusion Criteria:\n\n* Personal history of colorectal cancer.\n* Inflammatory bowel disease (IBD)\n* Colorectal polyps requiring specific clinical follow-up.\n* Hereditary polyposis syndromes.\n* High-risk family history of colorectal cancer: a first-degree relative diagnosed before age 50, or two or more first-degree relatives at any age.\n* Severe morbidity that precludes the performance of a colonoscopy in the event of a positive test result.","50 Years","69 Years",{"count":169,"type":20},10084,[92],"Colorectal cancer is a leading cause of mortality in Catalonia. Although early detection programs using the fecal immunochemical test (FIT) are effective in reducing both incidence and mortality, their success relies on high population participation. Currently, in the Vallès Occidental region, the participation rate stands at 42%, which is below the 65% minimum recommended by European health authorities. The objective of this randomized controlled trial is to evaluate whether sending a reminder text message (SMS) is an effective tool to increase participation in the screening program. The study will include 10,084 participants aged between 50 and 69 years. Half of the participants will receive a reminder SMS five weeks after their initial invitation, while the other half will follow the standard of care involving postal letters. Researchers anticipate that this strategy will not only increase the number of individuals undergoing screening but also shorten the response time and reduce the need for sending postal reminders",[30,173],"Early Detection of Cancer",[175,176,177,178,179,180,181,182,183,184],"Colorectal Cancer Screening","Text Messaging","Fecal Occult Blood Test","Public Health","Patient Participation","Reminder Systems","SMS Reminders","mHealth","Cancer Prevention","Patient Adherence","2026-06-18",{"date":187,"type":37},"2026-06-22",{"date":189,"type":37},"2026-05-05",{"date":191,"type":20},"2026-12",{"name":193,"class":194},"Corporacion Parc Tauli","OTHER",{"id":196,"slug":4,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":21,"phases":203,"briefSummary":204,"conditions":205,"keywords":210,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},"100546861","NCT06400472","A Study of LY4170156 in Participants With Selected Advanced Solid Tumors","A First-in-Human, Phase 1a\u002F1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4170156, an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors","Inclusion Criteria:\n\n* Have one of the following solid tumor cancers:\n\n  * Dose Escalation: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer, endometrial cancer, cervical cancer, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), pancreatic cancer, or colorectal cancer (CRC)\n  * Dose Optimization: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) and endometrial cancer\n  * Dose Expansion: Low grade serous ovarian cancer, cervical cancer, NSCLC, and TNBC\n\nExclusion Criteria:\n\n* Individual with known or suspected uncontrolled central nervous system (CNS) metastases\n* Individual with history of carcinomatous meningitis\n* Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection\n* Individual with evidence of corneal keratopathy or history of corneal transplant\n* Any serious unresolved toxicities from prior therapy\n* Significant cardiovascular disease\n* Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)\n* History of pneumonitis\u002Finterstitial lung disease\n* Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention",{"count":202,"type":20},495,[23],"The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.",[27,29,206,207,208,209,30],"Uterine Cervical Neoplasms","Carcinoma, Non-Small-Cell Lung","Triple Negative Breast Neoplasms","Pancreatic Neoplasm",[211,212,213,214,215,216,217,218,219,220,221,222,223,224],"Folate receptor alpha","NSCLC","Ovarian cancer","Cervical cancer","Endometrial cancer","Solid tumor","Lung cancer","Breast cancer","Pancreatic cancer","Colorectal cancer","Anti-drug conjugate","Phase I","Chemotherapy","sofe-m","2026-06-17",{"date":185,"type":37},{"date":228,"type":37},"2024-05-20",{"date":230,"type":20},"2027-04",{"name":137,"class":44},23,{"id":234,"slug":4,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":16,"minAge":239,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":242,"phases":4,"briefSummary":243,"conditions":244,"keywords":249,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":4,"leadSponsor":257,"locationsCount":109},"100202701","NCT01915225","Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer","Tumor, Normal Tissue and Specimens From Patients Undergoing Evaluation or Surgical Resection of Solid Tumors","* INCLUSION CRITERIA:\n* Participants must be 2 years of age or older. Note: Participants greater than or equal to 2 and \\\u003C 18 years of age may only participate in research sample collection if the tissue acquisition is performed during a clinically indicated surgical procedure, and the biospecimen sampling (e.g., blood, urine, ascites, bile, or \\[clinically indicated\\] resected tumor tissue) does not add risk to the clinically indicated procedures.\n* Participants who have premalignant, primary, or metastatic solid tumors based upon either radiographic or clinical suspicion, biochemical testing, a genetic predisposition, or histological\u002Fcytological analysis that requires surgery or biopsy as part of the diagnosis, prevention, treatment, and\u002For follow-up.\n* Participants without solid tumors in whom a diagnostic, preventative, or therapeutic intervention is being performed, but for whom surgical quality and safety outcomes data are generated.\n* Participants should have laboratory and physical examination parameters within acceptable limits prior to biopsy or surgery.\n* Participants must be planning to undergo surgery or biopsy as part of their normal treatment plan.\n* Ability of participant, parent\u002Fguardian or legally authorized representative (LAR) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nNone.","2 Years",{"count":241,"type":20},1800,"OBSERVATIONAL","Background:\n\n\\- Recent advances in cancer research have led to new therapies to treat the disease. It is important to continue these advances and discover new ones. To do that, researchers need tissue samples from solid tumors. This study will collect such samples from people already scheduled to have a procedure at the National Institutes of Health Clinical Center (NIHCC).\n\nObjectives:\n\n\\- To collect tissue samples for use in studying new ways to treat tumors.\n\nEligibility:\n\n* Adults 18 years and older, with a precancerous or cancerous solid tumor who are scheduled to have surgery or a biopsy at the NIHCC.\n* Children under the age of 18 but who are older than 2 years of age are eligible to be enrolled on the research sample collection portion of this study if they will have a biopsy or surgery as part of their medical care.\n\nDesign:\n\n* Before their procedure, participants will have a small blood sample taken.\n* Some participants will undergo leukapheresis. In this procedure, blood is removed through a tube in one arm and circulated through a machine that removes white blood cells. The blood, minus the white blood cells, is returned through a tube in the other arm. The procedure takes 3-4 hours.\n* For all participants, during the surgery or biopsy, pieces of the tumor and pieces of normal tissue near it will be removed for this study. The rest of the tumor or precancerous growth will be sent to a lab for analysis.\n* Participants will return to the clinic about 6 weeks after the operation for a routine checkup. Some may have to return for additional follow-up.",[30,245,246,247,248],"Gastric Neoplasms","Cholangiocarcinoma","Bile Duct Cancer","Pancreas Cancer",[250,251,252,253],"Tissue Procurement","Surgery","Metastasectomy","Natural History",{"date":185,"type":37},{"date":256,"type":37},"2013-07-21",{"name":76,"class":77},{"id":259,"slug":4,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":16,"minAge":264,"maxAge":265,"enrollmentInfo":266,"targetDuration":4,"studyType":21,"phases":268,"briefSummary":269,"conditions":270,"keywords":273,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":4},"100641936","NCT07644910","Nudging Preventive Screening Via Message Framing and Bundling","The Effect of Message Framing and Screening Bundling on Preventive Screening Engagement: A Randomized Field Experiment","Inclusion Criteria:\n\n* Has at least one pending cancer screening (breast, colorectal, cervical, or prostate) within the contact window, as determined by the medical institution\n* Aged 21 to 74 years\n* Has a valid phone number on file\n* Eligibility is determined operationally before randomization (ex-ante)\n\nExclusion Criteria:\n\n* Participants whose WhatsApp message was not successfully delivered, as reported by the third-party software used by the medical institution.","21 Years","74 Years",{"count":267,"type":20},235000,[92],"This study is a randomized controlled field experiment embedded in the medical institution Early Diagnosis Program in Chile. Participants with two exams pending (a cancer screening test and a chronic disease test for diabetes and dyslipidemia) will be randomly assigned across a 3 × 3 factorial design: three message framing conditions (Basic, Risk\u002FImportance, Peace of Mind) crossed with three exam-type conditions (cancer screening only, chronic disease test only, or both exams). Participants with only a cancer screening pending will be assigned to the 3 framing conditions and be encouraged to get the cancer screening.\n\nIn both cases, participants are assigned to each experimental arm at twice the rate of an additional arm receiving the standard message currently used by the medical institution. This standard-message arm is included for operational purposes, is not part of the pre-specified analyses, and is thus not described in the \"Arms and Intervention\" section (or counted for \"number of arms\").",[122,206,30,28,271,272],"Diabetes Mellitus","Dyslipidemias",[274,275,276,277,278,279,280,281],"Behavioral science","randomized controlled trial","WhatsApp patient outreach","message framing","information avoidance","cancer screening","chronic disease testing","preventive care","2026-06-15",{"date":225,"type":37},{"date":285,"type":20},"2026-06-08",{"date":287,"type":20},"2026-12-08",{"name":289,"class":194},"University of Chile",{"id":291,"slug":4,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":86,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":242,"phases":4,"briefSummary":299,"conditions":300,"keywords":318,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":335,"locationsCount":337},"100542405","NCT06342440","Early Detection of Advanced Adenomas and Colorectal Cancer","A Liquid Biopsy Assay For The Non-Invasive Early Detection of Advanced Adenomas and Colorectal Cancer","AACRC","Inclusion Criteria:\n\n* All individuals included in the study need to have had a colonoscopy at the time of blood sampling.\n* Received standard diagnostic and staging (as necessary) procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment.\n* Received standard pathological and endoscopic diagnosis and assessment for cohort assignment.\n\nExclusion Criteria:\n\n* Hereditary colorectal cancer syndromes (identified through genetic testing).\n* Inflammatory bowel diseases.\n* Lack of written informed consent.",{"count":298,"type":20},2000,"This study aims to develop a highly sensitive, specific, and cost-effective blood assay for early detection of colorectal adenomas and cancer, using advanced machine learning and state-of-the-art biological analyses.",[301,30,302,303,304,305,306,307,308,309,310,311,312,313,314,315,316,317],"Colorectal Cancer","Colorectal Polyp","Colorectal Adenocarcinoma","Colorectal Disorders","Colorectal Dysplasia","Colorectal Cancer Stage I","Colorectal Cancer Stage II","Colorectal Cancer Stage III","Colorectal Cancer Stage IV","Colorectal Neoplasms Malignant","Colorectal Serrated Adenocarcinoma","Colorectal Adenoma With Severe Dysplasia","Colorectal Adenoma With Mild Dysplasia","Colorectal Adenoma With Moderate Dysplasia","Colorectal Adenoma and Carcinoma 1","Colorectal Adenomatous Polyp","Colorectal Adenocarcinoma Metastatic in the Liver",[319,320,321,322,323,324,325,326,327,328,329,330],"Early detection","Micro RNA","miRNA","Liquid biopsy","Machine learning","Artificial Intelligence","Incidence","Polypectomy","Screening","Surveillance","Exosome","Vascicles",{"date":225,"type":37},{"date":333,"type":37},"2020-03-15",{"date":185,"type":20},{"name":336,"class":194},"City of Hope Medical Center",6,{"id":339,"slug":4,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":21,"phases":346,"briefSummary":347,"conditions":348,"keywords":350,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":45},"100577963","NCT06805123","Early Feeding Versus Delayed Feeding After Colorectal Endoscopic Submucosal Dissection","Comparison of Clinical Outcomes According to Timing of Dietary Restart After Colorectal Endoscopic Submucosal Dissection: A Prospective, Multicenter, Randomized Controlled Trial","Inclusion Criteria: Patients undergoing colorectal endoscopic submucosal dissection for the following lesions:\n\n* Differentiated early colorectal cancer confined to the mucosa, without ulcers, and measuring ≤5 cm\n* Laterally spreading tumors measuring ≥2 cm\n* Sessile polyps measuring ≥2 cm\n* Adenomas accompanied by fibrosis\n* Differentiated early cancer of the colon or rectum without lymph node metastasis, aside from those covered by partial self-payment insurance (Korean National Health insurance)\n* Submucosal tumors of the colon or rectum\n* Patients who have signed the consent form to participate in this study\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Patients with unresolved colorectal cancer\n* Patients with non-remissive inflammatory bowel disease (IBD)\n* Patients with blood coagulation disorders\n* Patients with a prothrombin time (PT) INR ≥ 1.5 despite medical correction\n* Pregnant patients\n* Patients who refuse to participate in this study",{"count":345,"type":20},204,[92],"Currently, there are no clear guidelines regarding the optimal timing for dietary restart after gastrointestinal endoscopic submucosal dissection (ESD). While several studies have addressed upper gastrointestinal ESD, a meta-analysis reported that early feeding, initiated within one day after the procedure, showed no statistically significant difference in complication rates compared to delayed feeding initiated after two or more days. Moreover, early feeding was associated with shorter hospital stays and higher patient satisfaction. However, to the best of our knowledge, no studies have investigated early feeding in colorectal ESD.\n\nOn the other hand, in the context of surgical procedures involving the gastrointestinal tract, several studies suggest that early feeding may offer clinical advantages over delayed feeding.\n\nThe aim of this study is to explore the optimal timing for dietary restart following colorectal ESD. In the early feeding group (\\\u003C24 hours), patients begin water intake if no abnormalities are observed during a follow-up examination conducted two hours post-procedure. If no further issues arise after an additional two hours, a liquid diet is initiated. In contrast, the delayed feeding group (\\>24 hours) maintains fasting on the day of the procedure and begins a liquid diet the following day. The study will compare the early and delayed feeding groups in terms of early post-procedural adverse events (occurring within 24 hours after the procedure)(e.g., bleeding, perforation, post-coagulation syndrome), patient satisfaction, and delayed post-procedural adverse events (occurring more than 24 hours after the procedure).",[349,30],"Endoscopic Submucosal Dissection",[351,352,353],"colorectum","endoscopic submucosal dissection","feeding","2026-06-14",{"date":225,"type":37},{"date":357,"type":37},"2025-02-01",{"date":359,"type":20},"2026-12-30",{"name":361,"class":194},"Pusan National University Hospital",{"id":363,"slug":4,"hasResults":11,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":368,"targetDuration":4,"studyType":21,"phases":370,"briefSummary":371,"conditions":372,"keywords":382,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":399,"locationsCount":109},"100461298","NCT05286814","PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma","Phase II Study Evaluating the Efficacy of PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma","* INCLUSION CRITERIA:\n\nInclusion Criteria- All Cohorts\n\n* Participants must have a documented diagnosis of one of the following cancers:\n\n  * Metastatic colorectal cancer (mCRC)\n  * Intrahepatic cholangiocarcinoma (ICC)\n  * Adrenocortical carcinoma (ACC) with liver dominant disease\n* Participants must have an identified medical oncologist who has recommended and is planning to oversee treatment with one of the following standard chemotherapy regimens (based on disease type) not to begin sooner than 28 days after initiation of study-directed HAIP intervention:\n\n  * mCRC: FOLFOX or FOLFIRI\n  * ICC: GemOx or FOLFOX\n  * ACC: GemOx\n* Age \\>= 18 years.\n* Negative serum or urine pregnancy test at screening for individuals of childbearing potential (IOCBP).\n\nNOTE: IOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal. IOCBP must have a negative pregnancy test (HCG blood or urine) during screening.\n\n* All participants (regardless of childbearing potential) must agree to use highly effective contraception prior to study entry, for the duration of study participation, and for 3 months after completion of study treatment for those able to father a child or 6 months after completion of study treatment for those of child-bearing potential (i.e., IOCBP). Highly effective birth control (failure rate of less than 1%), e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner and sexual abstinence. Note: The use of condoms by participants who are able to get other individuals pregnant is required unless the partner of childbearing potential is permanently sterile.\n* Nursing (including breastfeeding) participants must agree to discontinue nursing.\n* Arterial anatomy on CT angiogram or CT chest, abdomen and pelvis multiphase (i.e., CT C\u002FA\u002FP multiphase) amenable to placement of the HAIP.\n* Participant must sign the informed consent form to participate in this study.\n* HIV-positive participants may be considered for this study only if they have an undetectable viral load.\n* Participants must agree to co-enroll on the Surgical Oncology Program s tissue collection protocol 13C0176, \"Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors\".\n* Participant's liver metastases must not be amenable to resection\u002Fablation to No Evidence of Disease (NED) in one stage.\n\nInclusion Criteria-Metastatic Colorectal Carcinoma\n\n* Participants must have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma metastatic to the liver (Cohort 1).\n* Participants must have measurable liver metastatic disease.\n* Participants must have received 1st line systemic chemotherapy.\n* ECOG performance status \\\u003C= 1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\> 3,000\u002FmcL\n  * absolute neutrophil count \\> 1,500\u002FmcL\n  * platelets \\> 90,000\u002FmcL\n  * hemoglobin \\> 8 g\u002FdL\n  * total bilirubin \\\u003C 1.5 X institutional upper limit of normal\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C 2.5 X institutional upper limit of normal\n  * creatinine within normal institutional limits OR eGFR within normal as predicted by the CKD-EPI equation \\> 60 mL\u002Fmin\u002F1.73 m2.\n\nInclusion Criteria-Intrahepatic Cholangiocarcinoma\n\n* Participants must have histologically or cytologically confirmed diagnosis of intrahepatic cholangiocarcinoma confined to the liver (Cohort 2). Archival tumor sample may be used but if archival tissue is not available or is not adequate, tissue biopsy will be required.\n* Clinical or radiographic evidence of metastatic disease to regional (porta hepatis) lymph nodes will be allowed, provided it is amenable to resection.\n* Participants must have radiographically measurable disease.\n* Disease must be considered unresectable at the time of preoperative evaluation.\n* Participants must have received 1st line systemic chemotherapy.\n* ECOG performance status \\\u003C=1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\>= 2,000\u002F mm\\^3\n  * absolute neutrophil count \\> 1,500\u002FmcL\n  * platelets \\>= 75,000\u002F mm\\^3\n  * hemoglobin \\> 8 g\u002FdL\n  * total bilirubin \\\u003C 1.5 mg\u002Fdl\n  * creatinine \\\u003C= 1.5 mg\u002Fdl\n\nInclusion Criteria-Adrenocortical Carcinoma\n\n* Participants must have histologically or cytologically confirmed diagnosis of adrenocortical carcinoma (ACC), also referred to as \"adrenocortical cancer\".\n* Participants must have received at least one line of systemic chemotherapy.\n* Participants must have measurable liver metastatic disease.\n* ECOG performance status \\\u003C= 1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\> 3,000\u002FmcL\n  * absolute neutrophil count \\> 1,500\u002FmcL\n  * platelets \\> 90,000\u002FmcL\n  * hemoglobin \\> 8 g\u002FdL\n  * total bilirubin \\\u003C 1.5 X institutional upper limit of normal\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C 3 X institutional upper limit of normal\n  * creatinine \\\u003C 2 X institutional upper limit of normal\n\nEXCLUSION CRITERIA:\n\nExclusion Criteria- All Cohorts\n\nParticipants who are receiving any other investigational agents.\n\n* Participants who have previously received rIL-12.\n* Participants with active autoimmune diseases, that might deteriorate when receiving an immunostimulatory agent with the exceptions:\n\n  * diabetes type I, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible;\n  * participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses \\\u003C= 10 mg of prednisone or equivalent per day;\n  * administration of steroids for other conditions through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) is eligible.\n* History of organ transplant, except for transplants that do not require immunosuppression.\n* History of or active inflammatory bowel disease (e.g., Crohn s disease, ulcerative colitis).\n* Known hypersensitivity or allergic reactions attributed to any compounds of similar chemical or biologic composition to the study medication, such as recombinant IL-12 or other monoclonal antibodies and history of allergic reactions attributed to compounds of similar chemical composition to FUDR or heparin.\n* Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke \\\u003C 6 months prior to enrollment, myocardial infarction \\\u003C 6 months prior to enrollment, unstable angina, congestive heart failure (\\>= NYHA III) or serious cardiac arrhythmia requiring medication.\n* All conditions associated with significant necrosis of nontumor-bearing tissues.\n* Esophageal or gastroduodenal ulcers \\\u003C 6 months prior to treatment.\n* Active ischemic bowel disease.\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Active concurrent malignancies within the last five years other than colorectal primary except basal cell skin carcinoma and thyroid carcinoma.\n* Prior radiation to liver.\n* Participants with active Hepatitis B or C infection.\n* Significant acute or chronic infections (i.e., tuberculosis) history of exposure or history of positive tuberculosis test; plus, presence of clinical symptoms, physical or radiographic findings).\n* Any condition, including the presence of laboratory abnormalities and\u002For insufficient normal liver parenchyma, which places the participant at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study.\n\nExclusion Criteria-Metastatic Colorectal Carcinoma\n\n-Participants with incontrovertible radiographic evidence of disease outside of the colon\u002Frectum (primary) and liver given unlikelihood of benefit from liver-directed therapy.\n\nNote: Lung lesions seen on CT do not always represent metastases. They are very hard to qualify, therefore exception to this exclusion is participants with fewer than five lung lesions greater than 1 cm that have not increased in size by more than 10% over a 4-month period of time and are amenable to resection should subsequent problematic growth occur. Lesions less than 1 cm are indeterminant as far as etiology is concerned and will be ignored. Participants with liver metastases and oligometastatic lung lesions (we define oligometastatic as less than 5 amenable to thoracoscopic removal) are still likely to benefit from liver directed therapy.\n\n* Participants who have undergone extra-hepatic metastasectomy and have a documented disease-free interval less than or equal to 4 months.\n* Participants with a history of MSI-high results who need to be treated with check-point inhibitors.\n* Prior treatment with FUDR.\n\nExclusion Criteria-Intrahepatic Cholangiocarcinoma\n\n-Presence of distant metastatic disease. Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed, provided it is amenable to resection.\n\nNote: Lung lesions seen on CT do not always represent metastases. They are very hard to qualify, therefore exception to this exclusion is participants with fewer than five lung lesions greater than 1 cm that have not increased in size by more than 10% over a 4-month period of time and are amenable to resection should subsequent problematic growth occur. Lesions less than 1 cm are indeterminate as far as etiology is concerned and will be ignored. Participants with liver metastases and oligometastatic lung lesions (we define oligometastatic as less than 5 amenable to thoracoscopic removal) are still likely to benefit from liver directed therapy.\n\n* Prior treatment with FUDR.\n* Diagnosis of sclerosing cholangitis.\n* Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis).\n\nExclusion Criteria-Adrenocortical Carcinoma\n\n* Participants with incontrovertible radiographic evidence of additional abdominal disease outside of the liver (including the primary tumor) that is not amenable to complete surgical extirpation at the time of pump placement.\n* Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis).\n* Diagnosis of sclerosing cholangitis.\n* Participants with pulmonary metastases that have progressed by RECIST criteria in the preceding 3 months prior to study enrollment.\n* Participants with known mismatch repair mutation who have not been treated with a checkpoint inhibitor. Acceptable methods of MSI testing for history of MSI results include immunohistochemistry (IHC) and next generation sequencing (NGS) of tumor material.",{"count":369,"type":20},70,[24],"Background:\n\nOne way to treat liver cancer is to deliver chemotherapy drugs only to the liver (and not to the whole body). Researchers want to see if adding the drug PDS01ADC can improve the treatment. The drug triggers the immune system to fight cancer.\\\u003CTAB\\>\n\nObjective:\n\nTo see if treatment with HAIPs to deliver liver-directed FUDR and Dexamethasone chemotherapy in combination with PDS01ADC is effective for certain cancers.\n\nEligibility:\n\nPeople aged 18 and older who have cancer of the bile ducts that is only in the liver, or colorectal cancer that has spread to the liver, or cancer of the adrenal glands that has spread to the liver, who are also receiving or planning to receive standard systemic chemotherapy for their disease.\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood tests\n\nPregnancy test (if needed)\n\nTumor biopsy (if needed)\n\nElectrocardiogram\n\nComputed tomography (CT) scans\n\nParticipants will have an abdominal operation. A catheter will be placed into an artery that feeds blood to the liver. The catheter will then be attached to the HAIP. The HAIP will lay under the skin on the left side of the abdomen.\n\nAll participants will have liver-directed FUDR and Dexamethasone chemotherapy drugs or heparin with saline infused into the HAIP every 2 weeks. PDS01ADC will be injected under the skin every 4 weeks. They will receive this treatment until their cancer gets worse or they have bad side effects.\n\nParticipants will also receive standard systemic chemotherapy for their disease, assigned based on diagnosis, through an IV by their medical oncologist (at NIH or by a local provider) every 2 weeks.\n\nParticipants will have 2 study visits at NIH each month. They will have CT scans every 8 weeks. At visits, they will repeat some screening tests.\n\nParticipants will have a follow-up visit 1 month after treatment ends. Then they will be contacted every 6 months for 5 years.",[373,374,375,30,301,246,376,247,377,378,379,380,381],"Metastatic Colorectal Cancer (Mcrc)","Intrahepatic Cholangiocarcinoma (Icc)","Intrahepatic Bile Duct Cancer","Bile Duct Neoplasms","Adrenocortical Carcinoma (ACC)","Adrenal Cortical Carcinoma","Adrenal Gland Cancer","Adrenal Gland Neoplasms","Adrenal Cortex Neoplasms",[383,384,385,386,387,388,389,390,391,392],"Unresectable Liver Tumor","SMART System","Response Rates","Progression Free Survival (Pfs)","Patient Survival","Overall Survival (Os)","NHS-IL12","Mcrc","Icc","ACC","2026-06-09",{"date":395,"type":37},"2026-06-10",{"date":397,"type":37},"2022-10-24",{"date":74,"type":20},{"name":76,"class":77},{"id":401,"slug":4,"hasResults":11,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":406,"enrollmentInfo":407,"targetDuration":4,"studyType":21,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":78},"100643672","NCT07623642","A Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors.","An Open-Label, Multicenter, Non-Randomized, Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors","Inclusion Criteria\n\n1. Voluntarily signed written informed consent (ICF) prior to any study-specific procedures.\n2. Able and willing to participate in and comply with study procedures throughout the study.\n3. Age ≥ 18 and ≤ 80 years, any gender.\n4. Histologically confirmed unresectable, locally advanced, or metastatic solid tumor.\n5. Must have failed standard of care (SOC), be intolerant to SOC, or be deemed by the investigator to be unsuitable for a specific form of SOC. If SOC failure, documented progression from SOC is required.\n6. No more than 2 prior lines of systemic therapy. Subjects with more lines may be enrolled after sponsor approval. Treatment-naive subjects with locally advanced or metastatic melanoma who have not received systemic therapy may enroll.\n7. Tumor types include: endometrial cancer, cervical cancer, ovarian cancer, triple-negative breast cancer, prostate cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, hepatocellular carcinoma (HCC), biliary tract malignancies (including only intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer; excluding ampullary carcinoma), pMMR\u002FMSS colorectal adenocarcinoma, pancreatic ductal adenocarcinoma, non-small cell lung cancer (NSCLC), small cell lung cancer, and melanoma (assessed per local institutional standard practice).\n8. For certain tumor types, IGSF8 protein expression on the tumor cell membrane must be positive at pre-screening or screening.\n9. If the subject has received prior anti-PD-1\u002FPD-L1 therapy, documented disease progression during treatment with anti-PD-1\u002FPD-L1 monoclonal antibody (as monotherapy or combined with other checkpoint inhibitors\u002Ftherapies) is required.\n10. Eligible subjects of childbearing potential (female and male) must agree to use effective contraception (hormonal or barrier method) starting 28 days prior to the first dose of GV20-0251, throughout the treatment period, and for at least 4 months after the last dose.\n11. Must have at least one measurable lesion per RECIST v1.1. Previously irradiated lesions with documented progression may be considered measurable.\n12. Must provide archival tumor tissue collected within 3 years prior to signing the ICF. If archival tissue is \\>3 years old, enrollment requires medical confirmation with the sponsor.\n13. ECOG performance status of 0-1 prior to the first dose on C1D1.\n14. Expected survival ≥ 24 weeks.\n15. No history of other primary malignancies, except: (a) a curatively treated malignancy with no active disease for at least 2 years prior to consent and low risk of subsequent relapse; or (b) curatively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast.\n16. Adequate organ, Hepatic, and Coagulation function at screening.\n17. All adverse events related to prior anticancer therapy have resolved to ≤ Grade 1 (per NCI CTCAE v5.0). For persistent Grade 2 toxicities deemed by the investigator unlikely to resolve, eligibility may be discussed with the sponsor.\n18. For HCC or biliary tract malignancy subjects only, as Child-Pugh Class A.\n\nExclusion Criteria\n\n1. Prior immunotherapy discontinued due to ≥ Grade 3 immune-related adverse events (irAEs) - except endocrine disorders manageable with replacement therapy or asymptomatic elevated serum amylase\u002Flipase - Grade 2 myocarditis, or recurrent Grade 2 pneumonitis.\n2. Insufficient washout period from prior systemic anticancer therapy before initiating GV20-0251 and anti-PD-1 therapy (C1D1)\n3. Received radiotherapy within 2 weeks prior to initiating GV20-0251 and anti-PD-1 therapy, or has radiation-related toxicity requiring corticosteroids. For NSCLC subjects: pulmonary radiotherapy \\> 30 Gy within 6 months prior to C1D1.\n4. Currently enrolled in a drug or device clinical trial; or received an investigational device or investigational drug within 4 weeks prior to C1D1.\n5. Diagnosed with immunodeficiency; or currently receiving chronic systemic corticosteroids (\\> 10 mg\u002Fday prednisone equivalent) or any other form of immunosuppressive therapy.\n6. History of gastrointestinal perforation and\u002For fistula within 6 months prior to consent; or active gastric\u002Fduodenal ulcer, ulcerative colitis, or other GI conditions the investigator believes may cause bleeding or perforation.\n7. Clinically significant and\u002For uncontrolled cardiac disease, including NYHA Class III or IV heart failure, uncontrolled hypertension (systolic BP \\> 160 mmHg), clinically significant arrhythmia assessed by the investigator to affect study participation safety, or myocardial infarction within 6 months prior to C1D1.\n8. Severe hypersensitivity reaction (≥ Grade 3) to anti-PD-1 monoclonal antibody and\u002For any of its excipients; or prior severe hypersensitivity to biologic therapies that the investigator considers may increase subject risk.\n9. Acute leukemia or chronic lymphocytic leukemia (CLL).\n10. QTcF \\> 470 msec, or history of congenital long QT syndrome, or clinically significant ECG abnormalities (including pericarditis) that the investigator considers may affect subject safety.\n11. Active infection requiring systemic treatment; or active, uncontrolled bacterial, viral, or fungal infection requiring systemic treatment within 7 days prior to C1D1.\n12. History of (non-infectious) pneumonitis\u002Finterstitial lung disease requiring steroid treatment, or current pneumonitis\u002Finterstitial lung disease.\n13. Active autoimmune disease requiring systemic treatment within 2 years prior to C1D1\n14. HIV infection.\n15. Active HBV or HCV infection\n16. Prior major organ transplantation\n17. Prior autologous or allogeneic bone marrow transplantation.\n18. Symptomatic primary CNS malignancy, CNS metastases, or leptomeningeal disease.\n19. Major surgery (excluding diagnostic procedures) or severe trauma within 28 days prior to the first dose of GV20-0251, or currently in recovery that the investigator deems would interfere with the study, or anticipated major surgery during the study.\n20. Received a live or attenuated vaccine within 30 days prior to the first dose.\n21. Requires treatment with interferon-α or related\u002Fsimilar agents within 3 weeks prior to C1D1 or during the entire study period.\n22. Requires more than one paracentesis per 8 weeks to manage ascites; or single ascites drainage volume \\> 1.5 liters within 8 weeks prior to C1D1.\n23. Psychiatric illness or substance abuse disorder (e.g., drug abuse, alcohol dependence) that may interfere with the subject's ability to comply with study requirements.\n24. Other serious non-malignant conditions or laboratory abnormalities that, in the opinion of the investigator and\u002For sponsor, make the subject unsuitable for the study; or other circumstances that the investigator believes may confound study results or prevent the subject from completing the study.\n25. Additional exclusion criteria that applicable to HCC or biliary tract malignancy subjects.","80 Years",{"count":408,"type":20},227,[24],"This is a Phase 2 study of GV20-0251 in combination with anti-PD-1 monoclonal antibodies (including tislelizumab and toripalimab) for the treatment of participants with unresectable, locally advanced, or metastatic solid tumors who are refractory to, intolerant of, or ineligible for standard of care.",[206,208,28,412,413,246,414,30,415,207,416],"Squamous Cell Carcinoma of Head and Neck","Esophageal Squamous Cell Carcinoma","Gallbladder Neoplasms","Pancreatic Ductal Adenocarcinoma","Small Cell Lung Carcinoma","2026-06-04",{"date":285,"type":37},{"date":420,"type":20},"2026-06-02",{"date":422,"type":20},"2029-08-15",{"name":424,"class":44},"GV20 Therapeutics",{"id":426,"slug":4,"hasResults":11,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":21,"phases":433,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":443},"100601187","NCT07107230","A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors","A Phase 1 Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors","Inclusion Criteria:\n\n* Participants must have been previously diagnosed with histologically confirmed unresectable, locally advanced, or metastatic non-small cell lung cancer, colorectal carcinoma, or head and neck squamous cell carcinoma\n* Participants with non-small cell lung cancer (NSCLC) adenocarcinoma and colorectal cancer (CRC) must have local molecular testing to determine epidermal growth factor receptor (EGFR) mutational status for NSCLC and Kirsten rat sarcoma\u002Fneuroblastoma ras viral oncogene\u002Fv-raf murine sarcoma oncogene B1 (KRAS\u002FNRAS\u002FBRAF) mutation status for CRC\n* Have measurable or evaluable disease:\n* Part 1: Either measurable or evaluable disease; Part 2: At least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) version (v) 1.1\n* Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1 at screening\n* Participants must have appropriate hematologic, renal, and hepatic function within the required limits\n\nExclusion Criteria:\n\n* Any prior medical history of ILD\u002Fpneumonitis, including pneumonitis from anti-PD-1\u002F PD-L1 antibody or radiation that required systemic steroids\n* Toxicity from prior anticancer therapy that has not resolved to Grade \\\u003C=1\n* Evidence of clinically significant active viral, bacterial, or fungal infection within 7 days before the first dose of study treatment requiring systemic or non-topical treatment\n* History of clinically significant cardiovascular disease within 6 months prior to signing informed consent\n* Participants with prior or concurrent second malignancy cannot be enrolled if prior\u002Fconcurrent malignancy's natural history of treatment is likely to interfere with any safety or efficacy study endpoints",{"count":432,"type":20},380,[23],"The purpose of this study is to determine recommended phase 2 doses (RP2Ds) of JNJ-95437446 in Part 1, and to further evaluate the safety of the RP2Ds in participants with advanced solid tumors in Part 2.",[30],{"date":437,"type":37},"2026-06-05",{"date":439,"type":37},"2025-07-15",{"date":441,"type":20},"2028-04-24",{"name":158,"class":44},9,{"id":445,"slug":4,"hasResults":11,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":449,"eligibilityCriteria":450,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":21,"phases":453,"briefSummary":455,"conditions":456,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":457,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":463},"100573731","NCT06750094","A Study of Amivantamab and FOLFIRI Versus Cetuximab\u002FBevacizumab and FOLFIRI in Participants With KRAS\u002FNRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy","A Randomized, Open-label Phase 3 Study of Amivantamab + FOLFIRI Versus Cetuximab\u002FBevacizumab + FOLFIRI in Participants With KRAS\u002FNRAS and BRAF Wild-type Recurrent, Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy","OrigAMI-3","Inclusion Criteria:\n\n* Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease\n* Determined to have kirsten rat sarcoma viral oncogene\u002Fneuroblastoma RAS viral oncogene homolog (KRAS\u002FNRAS), G12, G13 and v-raf murine sarcoma viral oncogene homolog B (BRAF) V600X (X represents any single amino acid change from the original amino acid) wild type status by local and\u002For central next-generation sequencing (NGS) testing\n* Must agree to the submission of fresh or archival tumor tissue post progression from the most recent therapy, if clinically feasible\n* Have measurable disease according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1\n* Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1\n* Participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mCRC), with documented radiographic disease progression on or after this line of therapy. Participants can receive anti-VEGF as prior line of therapy\n\nExclusion Criteria:\n\n* Has medical history of (noninfectious) interstitial lung disease (ILD) \u002Fpneumonitis\u002Fpulmonary fibrosis or has current ILD\u002Fpneumonitis\u002Fpulmonary fibrosis, or where suspected ILD\u002Fpneumonitis\u002Fpulmonary fibrosis cannot be ruled out by imaging at screening\n* Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: amivantamab, cetuximab or bevacizumab or any component of FOLFIRI\n* Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)\n* Participant with known mismatch repair deficiency (dMMR)\u002F high microsatellite instability (MSI-H) status who has not received immunotherapy treatments\n* Participant with known human epidermal growth factor receptor 2 (HER2)- positive\u002Famplified tumor\n* Has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET)",{"count":452,"type":20},700,[454],"PHASE3","The purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene\u002F neuroblastoma RAS viral oncogene homolog (KRAS\u002F NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.",[30],{"date":437,"type":37},{"date":459,"type":37},"2024-12-12",{"date":461,"type":20},"2029-04-13",{"name":158,"class":44},247,{"id":465,"slug":4,"hasResults":11,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":469,"eligibilityCriteria":470,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":471,"targetDuration":4,"studyType":21,"phases":473,"briefSummary":474,"conditions":475,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":482},"100567023","NCT06662786","A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS\u002FNRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer","A Randomized, Open-label Phase 3 Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS\u002FNRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer","OrigAMI-2","Inclusion Criteria:\n\n* Have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. Participants must have unresectable or metastatic disease\n* Determined to have Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type (WT) tumor by local and\u002For central testing (if available)\n* Must agree to the submission of fresh tumor tissue\n* Have measurable disease according to RECIST v1.1\n* Has not received any prior systemic therapy for unresectable or metastatic colorectal cancer (CRC). Prior adjuvant\u002Fneoadjuvant therapy in the non-metastatic disease is permitted. However, the last course of adjuvant or neoadjuvant chemotherapy must have concluded greater than (\\>) 12 months prior to CRC recurrence\u002Fmetastases\n* Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1\n\nExclusion Criteria:\n\n* Has medical history of (noninfectious) interstitial lung disease (ILD) \u002Fpneumonitis\u002Fpulmonary fibrosis or has current ILD\u002Fpneumonitis\u002Fpulmonary fibrosis, or where suspected ILD\u002Fpneumonitis\u002Fpulmonary fibrosis cannot be ruled out by imaging at screening\n* Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: (a) amivantamab or cetuximab, (b) any component of mFOLFOX6 and, (c) any component of FOLFIRI\n* Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)\n* Participant with known mismatch repair deficiency (dMMR)\u002F high microsatellite instability (MSI-H) status and human epidermal growth factor receptor 2 (HER2)-positive\u002Famplified tumor\n* Has prior exposure to any agents that target epidermal growth factor receptor (EGFR), mesenchymal epithelial transition (MET) or vascular endothelial growth factor (VEGF)",{"count":472,"type":20},1000,[454],"The purpose of this study is to compare how long the participants are disease-free (progression-free survival) when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin (mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS)\u002F Neuroblastoma RAS viral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) wild type (WT) unresectable or metastatic left-sided colorectal cancer.",[30],{"date":437,"type":37},{"date":478,"type":37},"2024-10-18",{"date":480,"type":20},"2032-01-20",{"name":158,"class":44},237,{"id":484,"slug":4,"hasResults":11,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":86,"sex":16,"minAge":87,"maxAge":265,"enrollmentInfo":489,"targetDuration":4,"studyType":21,"phases":491,"briefSummary":492,"conditions":493,"keywords":495,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":4},"100638461","NCT07612436","AI-empowered Nudge to Improve Colonoscopy Uptake (AINC)","AI-empowered Nudge to Improve Colonoscopy Uptake (AINC): A Pragmatic Cluster-Randomized Trial","Inclusion Criteria:\n\n* Aged 45-74 years;\n* Test positive on the Colorectal Cancer Risk Assessment Scale and the immunochemical fecal occult blood test;\n* In good general health, mentally competent;\n* Provide informed consent.\n\nExclusion Criteria:\n\n* History of colorectal resection;\n* Previous diagnosis of cancer or currently undergoing any cancer-related treatment;\n* Underwent a colonoscopy or sigmoidoscopy within the past 5 years;\n* Contraindications to colonoscopy (e.g. severe cardiac, cerebral, lung diseases, or renal dysfunction).",{"count":490,"type":20},1680,[92],"Colorectal cancer (CRC) ranks third in both incidence and mortality among all malignant tumors in China. Studies have shown that early screening can significantly reduce its incidence and mortality. Colonoscopy is the gold standard for CRC screening; however, compliance with colonoscopy among high-risk groups in China is very low. Artificial intelligence (AI)-assisted tools can provide real-time, personalized health education, and nudge strategies can help translate intent into action. This trial aims to evaluate the effectiveness of AI-empowered nudge for improving colonoscopy uptake among high-risk individuals aged 45 to 74 in China. It's a two-arm, pragmatic cluster randomized controlled trial. The main question it aims to answer is whether the AI-enabled personalized health education and nudge strategies improve colonoscopy adherence.\n\nParticipants will:\n\n1. Be recruited and allocated into one of two groups according to the assigned clusters. Participants in one group will be invited to receive usual care. In addition to usual care, participants in the other group will receive AI-empowered nudge, featuring an AI chatbot providing real-time personalized responses and a nudge environment with default screening option.\n2. Have their colonoscopy status checked at the end of trial.",[30,494],"Colonoscopy",[220,496,497,275,498,499],"artificial intelligence","screening adherence","nudge","Behavioral intervention","2026-06-03",{"date":417,"type":37},{"date":503,"type":20},"2026-05-30",{"date":505,"type":20},"2027-12-31",{"name":507,"class":194},"Fudan University",{"id":509,"slug":4,"hasResults":11,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":513,"eligibilityCriteria":514,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":515,"targetDuration":4,"studyType":21,"phases":517,"briefSummary":518,"conditions":519,"keywords":521,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":532},"100609377","NCT07213791","A Study of LY4337713 in Participants With FAP-Positive Solid Tumors","A Dose Escalation and Dose Optimization Phase 1a\u002F1b Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy With LY4337713 in Adults With FAP-Positive Solid Tumors (FiREBOLT)","FiREBOLT","Inclusion Criteria:\n\n* Must have clinical or imaging evidence of fibroblast activation protein (FAP) expression per local assessment\n* Must have histologically or cytologically confirmed diagnosis of one of the following:\n\n  * Adenocarcinoma of the pancreas\n  * Hormone receptor (HR)-positive human epidermal growth factor 2 (HER2)-negative breast cancer\n  * HER2-positive breast cancer\n  * Triple negative breast cancer (TNBC)\n  * Platinum-resistant or refractory ovarian cancer (including ovarian carcinosarcoma)\n  * Other solid tumors\n\n    * Gastric cancer (adenocarcinoma)\n    * Colorectal cancer (CRC)\n    * Esophageal cancer (squamous cell carcinoma or adenocarcinoma)\n    * Cholangiocarcinoma\n* Must have received prior treatments as indicated below:\n\n  * Phase 1a\n\n    * Adenocarcinoma of the pancreas: Participants must have received at least 1, but no more than 2 prior regimens for locally advanced unresectable or metastatic disease.\n    * HR-positive HER2-negative breast cancer: Participants must have received less than or equal to (≤)5 prior lines of treatment for advanced or metastatic disease, which must include a cyclin-dependent kinase 4\u002F6 inhibitor.\n    * HER2-positive breast cancer: Participants must have received at least 2 lines of HER2-targeted therapy, which should include at least 1 antibody-drug conjugate (ADC) for metastatic disease (if locally available).\n    * TNBC: Participants must have received at least 2 lines of therapy for metastatic disease.\n    * Platinum-resistant or refractory ovarian cancer: Participants must have received or after at least 1 platinum-based therapy.\n    * Other solid tumors (gastric cancer, CRC, esophageal and cholangiocarcinoma): Participants must have received greater than or equal to (≥)1 prior line of systemic therapy for advanced or metastatic disease; including prior line(s) in combination with immunotherapy or vascular endothelial growth factor inhibitor.\n  * Phase 1b:\n\n    * Participants must have advanced or metastatic solid tumors and have received ≥1 prior line of therapy.\n* Must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.\n* Measured creatinine clearance ≥60 milliliters per minute (mL\u002Fmin)\n\nExclusion Criteria:\n\n* Have known active central nervous system (CNS) metastases or carcinomatous meningitis.\n* Have significant cardiovascular disease\n* Have prolongation of the corrected QTcF \\>470 milliseconds (msec) during screening. QTcF is calculated using Fridericia's Formula: QTcF = QT\u002F(RR0.33)\n* Have evidence of ongoing and untreated urinary tract obstruction\n* Had previous hemi- or total-body radiation.\n* Had previous adoptive T-cell therapy (e.g., chimeric antigen receptor T-cell \\[CAR-T therapy, T-cell receptor \\[TCR\\] therapy, etc.)\n* Unable to lie flat during, or otherwise tolerate, single photon emission computed tomography (SPECT), positron emission tomography (PET), computed tomography (CT) or magnetic resonance imaging (MRI).",{"count":516,"type":20},241,[23],"This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with high levels of a protein called fibroblast activation protein (FAP). The purpose of this study is to evaluate safety, side effects, and efficacy of LY4337713. In addition, this study will evaluate how much LY4337713 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. For each participant, the study will last about 5 years.",[27,122,520,30,126,125,246],"Pancreatic Intraductal Neoplasms",[522,523,524,525],"Cancer-associated fibroblasts (CAF)","Lutetium-177","LuFAP","Lu-177-FAP",{"date":417,"type":37},{"date":528,"type":37},"2025-10-22",{"date":530,"type":20},"2033-03",{"name":137,"class":44},30,{"id":534,"slug":4,"hasResults":11,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":21,"phases":541,"briefSummary":542,"conditions":543,"keywords":552,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":558,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":565},"100610070","NCT07222800","Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer","AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER","Inclusion Criteria:\n\n* Histological or cytological confirmed colorectal adenocarcinoma.\n* Evidence of Stage IV metastatic disease.\n* No prior systemic therapy for metastatic disease.\n* Eastern Cooperative Oncology Group performance status (ECOG) 0-1\n* At least one measurable lesion according to RECIST 1.1 per Investigator assessment.\n* Adequate hepatic, liver, and renal function\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Locally confirmed BRAF V600E mutation\n* Locally confirmed microsatellite instability (MSI)-high or DNA mismatch repair deficiency (dMMR) colorectal cancer\n* Participants with known active symptomatic CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression\n* Clinically significant risk of hemorrhage or fistula\n* Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation\n* Any Grade ≥3 bleeding\u002Fhemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events\n* Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose\n* Participants with active autoimmune diseases requiring systemic treatment within the past 2 years\n* Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis",{"count":540,"type":20},800,[454],"The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before.\n\nTo join the study, participants must meet the following conditions:\n\n* Be 18 years or older.\n* Have colorectal cancer that has spread to other parts of your body.\n* Be in good enough health to receive study treatment.\n* Should not be pregnant before starting treatment.\n\nParticipants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm (Arm A) will include the new medicine PF-08634404 in combination with chemotherapy that is approved for colorectal cancer, and the second arm (Arm B) will include an approved medicine for colorectal cancer, called Bevacizumab, in combination with chemotherapy that is approved for this type of cancer. Participants and their doctors will not know which arm they are being assigned to. Participants will receive all the study medications through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, and participants may continue receiving it if it is helping and they are not experiencing serious side effects.\n\nThe medicine will be given at a clinical site, where trained medical staff will check participants during and after each treatment.\n\n* The study is expected to last approximately 33 months for each participant.\n* Participants will have regular visits to the study site for treatment, health checks, and tests.\n* After stopping treatment, participants will return for a final visit about 30 to37 days later to check their health and review any side effects.\n* Follow-up will continue every 12 weeks by phone or in person or by reviewing health records to check on health status and any new treatments.",[544,150,545,546,547,548,549,550,551,30],"Intestinal Neoplasms","Digestive System Neoplasms","Neoplasms by Site","Digestive System Diseases","Gastrointestinal Diseases","Colonic Diseases","Intestinal Diseases","Rectal Diseases",[553,554,555,556,557],"mCRC","metastatic disease","first-line","metastatic colorectal cancer","colon cancer",{"date":417,"type":37},{"date":560,"type":37},"2025-12-11",{"date":562,"type":20},"2031-08-01",{"name":564,"class":44},"Pfizer",228,{"id":567,"slug":4,"hasResults":11,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":4,"eligibilityCriteria":571,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":572,"targetDuration":4,"studyType":21,"phases":573,"briefSummary":574,"conditions":575,"keywords":576,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":581,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":109},"100309067","NCT03303495","A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC","A Multinational, Randomized, Phase III Study of FOLFIRI With\u002FWithout Bevacizumab Versus Irinotecan With\u002FWithout Bevacizumab As Second-line Therapy in Patients With Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Histologically-confirmed inoperable colorectal adenocarcinoma excluding vermiform appendix cancer and anal canal cancer.\n2. Age ≥18 years at the time of informed consent\n3. ECOG performance status (PS) of 0-2\n4. Written informed consent prior to study-specific screening procedures\n5. Life expectancy of at least 90 days\n6. Withdrawal from first-line chemotherapy (regardless of containing molecular-targeted drugs) for metastatic colorectal cancer due to intolerable toxicity or progressive disease, or relapse within 180 days after the last dose of adjuvant chemotherapy.\n7. Adequate organ function according to following laboratory values obtained within 14 days before enrolment (excluding patients who received blood transfusions or hematopoietic growth factors within 14 days before the laboratory test) Neutrophil count: ≥1500\u002Fmm3 Platelet count: ≥10.0 x 104\u002Fmm3 Hemoglobin: ≥9.0 g\u002FdL Total bilirubin: ≤1.5 mg\u002FdL AST, ALT: ≤100 IU\u002FL (≤200 IU\u002FI if liver metastases present) Serum creatinine: ≤1.5 mg\u002FdL\n\nExclusion Criteria:\n\n1. History of other malignancy with a disease-free interval \\\u003C5 years (other than curatively treated cutaneous basal cell carcinoma, curatively treated carcinoma in situ of the cervix, and gastroenterological cancer confirmed to be cured by endoscopic mucosal resection)\n2. With massive pleural effusion or ascites requiring intervention\n3. Radiological evidence of brain tumor or brain metastases\n4. Active infection including hepatitis\n5. Any of the following complication:\n\n   i) Gastrointestinal bleeding or gastrointestinal obstruction (including paralytic ileus) ii) Symptomatic heart disease (including unstable angina, myocardial infarction, and heart failure) iii) Interstitial pneumonia or pulmonary fibrosis iv) Uncontrolled diabetes mellitus v) Uncontrolled diarrhea (that interferes with daily activities despite adequate therapy)\n6. Any of the following medical history:\n\n   Myocardial infarction: History of one episode within one year before enrollment or two or more lifetime episodes i) Serious hypersensitivity to any of the study drugs ii) History of adverse reaction to fluoropyrimidines suggesting dihydropyrimidine dehydrogenase (DPD) deficiency\n7. Previous treatment with irinotecan hydrochloride\n8. Current treatment with atazanavir sulfate\n9. Previous treatment with tegafur, gimeracil, and oteracil potassium within seven days before enrollment\n10. Pregnant or lactating females, and males and females unwilling to use contraception\n11. Requires continuous treatment with systemic steroids\n12. Psychiatric disability that would preclude study compliance\n13. Otherwise determined by the investigator to be unsuitable for participation in the study\n14. Concurrent gastrointestinal perforation or history of gastrointestinal perforation with 1 year before enrollment\n15. History of pulmonary hemorrhage\u002Fhemoptysis ≥ Grade 2 (defined as bright red blood of at least 2.5mL) within 1 month prior to enrollment.\n16. History of laparotomy, thoracotomy, or intestinal resection within 28 days before enrollment\n17. Unhealed wound (except suture wounds from implantation of a central venous port), gastrointestinal ulcer, or traumatic fracture\n18. Current or recent (within 1 year) thromboembolism or cerebrovascular disease\n19. Currently receiving or requires anticoagulation therapy (\\> 325 mg\u002Fday of aspirin)\n20. Bleeding diathesis, coagulopathy, or coagulation factor abnormality (INR ≥1.5 within 14 days before enrollment)\n21. Uncontrolled hypertension\n22. Urine dipstick for proteinuria \\>+2",{"count":19,"type":20},[454],"The primary purpose of this study is to determine the non-inferiority of overall survival FOLFIRI with or without Bevacizumab compared with Irinotecan (CPT-11) with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.",[30,124,544,150,545],[577,578,579,580],"FOLFIRI","CPT-11","Bevacizumab","2nd-line metastatic colorectal cancer",{"date":437,"type":37},{"date":583,"type":37},"2011-11-14",{"date":585,"type":20},"2026-12-31",{"name":587,"class":194},"Sun Yat-sen University",{"id":589,"slug":4,"hasResults":11,"nctId":590,"briefTitle":591,"officialTitle":591,"acronym":4,"eligibilityCriteria":592,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":593,"targetDuration":4,"studyType":21,"phases":595,"briefSummary":596,"conditions":597,"keywords":606,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":609,"startDateStruct":610,"completionDateStruct":611,"leadSponsor":613,"locationsCount":4},"100643560","NCT07631871","An Exploratory Study of Zanidatamab in HER2-positive Advanced Tumor After at Least One Line of Standard Therapy","Inclusion Criteria:\n\n1. Male or female subjects aged ≥ 18 years old.\n2. Subjects with locally advanced, unresectable or metastatic solid tumors who have progressed after ≥1 prior systemic therapy for advanced\u002Fmetastatic disease, or have no available optimal alternative treatments. Qualified tumor types include but are not limited to endometrial carcinoma, urothelial carcinoma, pancreatic cancer, colorectal carcinoma (CRC), head and neck adenocarcinoma (salivary gland adenocarcinoma, lacrimal gland adenocarcinoma, adenocarcinoma of unknown primary of the neck), cervical cancer, ovarian cancer and adenocarcinoma of unknown primary. Biliary tract malignancy, lung cancer and breast cancer are excluded. For CRC patients: documented RAS status (wild-type or mutant) and wild-type BRAF; prior treatment regimen should contain fluoropyrimidine, oxaliplatin and irinotecan unless contraindicated; anti-VEGF therapy when clinically indicated; anti-PD-L1 therapy for MSI-H\u002FdMMR tumors if clinically indicated.\n3. ECOG Performance Status 0, 1 or 2.\n4. Confirmed HER2 positivity defined as IHC 3+, or IHC 2+ with positive FISH amplification (per GC criteria).\n5. Willing and capable of providing adequate tumor specimens for central pathological re-assessment of HER2 status at institutional pathology department. Patients previously treated with HER2-ADC must provide FFPE tumor samples collected after last HER2-ADC administration. Specimens with insufficient tumor cellularity and fine-needle aspiration samples are not acceptable for HER2 testing.\n6. At least one measurable lesion at baseline per RECIST 1.1 criteria.\n7. Adequate bone marrow and organ function confirmed within 14 days prior to enrollment: Hemoglobin ≥ 9 g\u002FdL; Platelet count ≥ 75,000\u002Fmm³; Absolute neutrophil count (ANC) ≥ 1000\u002Fmm³; Serum albumin ≥ 2.5 g\u002FdL; PT, aPTT and INR ≤ 1.5 × ULN; AST\u002FALT ≤ 3 × ULN; ≤5 × ULN for subjects with liver metastasis; Total bilirubin ≤1.5 × ULN (no liver metastasis); ≤3 × ULN (baseline Gilbert syndrome or liver metastasis); Creatinine clearance ≥30 mL\u002Fmin (calculated by Cockcroft-Gault formula)\n8. LVEF ≥50% evaluated via echocardiogram (ECHO) or MUGA scan within 28 days before enrollment.\n\nExclusion Criteria:\n\nSubjects with any of the following conditions are ineligible:\n\n1. Documented spinal cord compression, leptomeningeal disease or clinically active central nervous system (CNS) metastasis.\n2. Active primary immunodeficiency, confirmed HIV infection, active HBV or HCV infection.\n3. History of non-infectious interstitial lung disease (ILD)\u002Fnon-infectious pneumonia requiring steroid therapy, ongoing active ILD\u002Fnon-infectious pneumonia, or suspected ILD\u002Fnon-infectious pneumonia that cannot be ruled out by screening imaging.\n4. History of myocardial infarction, symptomatic congestive heart failure (CHF, NYHA Class II-IV), unstable angina, or any cardiovascular event (including stroke) within 6 months prior to enrollment.\n5. Pulmonary exclusion items: (a) Clinically significant underlying pulmonary disorders, including but not limited to pulmonary embolism within 3 months before screening, severe asthma, severe COPD, restrictive lung disease, recurrent pleural effusion; (b) Confirmed autoimmune, connective tissue or inflammatory diseases (rheumatoid arthritis, Sjögren's syndrome, sarcoidosis etc.), or suspected pulmonary involvement at screening; full disease details shall be recorded in eCRF for enrolled subjects; (c) Previous total pneumonectomy.\n6. Confirmed presence of HER2 gene mutation.",{"count":594,"type":20},10,[24],"The goal of this clinical trial is to learn if Zanidatamab can treat HER2-positive advanced tumors in adults. The main question it aims to answer is: What is the objective response rate of Zanidatamab in adult patients with HER-2 positive advanced solid tumors? Participants will receive Zanidatamab intravenously on Day 1 of each 2-week treatment cycle. The dosage is 20 mg\u002Fkg per cycle.",[598,599,600,601,602,603,30,604,605,27],"Neoplasms","Solid Tumors","HER2 Positive Solid Tumor","Endometrial Neoplasm","Urothelial Carcinoma (UC)","Pancreatic Neoplasms","Head and Neck Neoplasms","Cervical Neoplasms",[600,607,608],"Zanidatamab","Basket Study",{"date":285,"type":37},{"date":282,"type":20},{"date":612,"type":20},"2029-12-31",{"name":614,"class":194},"Haihua Yuan",{"id":616,"slug":4,"hasResults":11,"nctId":617,"briefTitle":618,"officialTitle":618,"acronym":4,"eligibilityCriteria":619,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":620,"targetDuration":4,"studyType":21,"phases":622,"briefSummary":623,"conditions":624,"keywords":633,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":637,"startDateStruct":638,"completionDateStruct":639,"leadSponsor":640,"locationsCount":4},"100643697","NCT07631884","Exploratory Study on the Efficacy and Safety of Trastuzumab Rezetecan in the Treatment of HER2-Expressiong Advanced Solid Tumor","Inclusion Criteria:\n\n1. Male and female participants aged 18 years or older.\n2. Participants with locally advanced, unresectable or metastatic solid tumors who have progressed after at least one prior systemic therapy for advanced\u002Fmetastatic disease, or have no satisfactory alternative treatment options. Eligible tumor types include but are not limited to biliary tract cancer, endometrial cancer, urothelial carcinoma, pancreatic cancer, colorectal cancer, gastric cancer, non-small cell lung cancer, head and neck adenocarcinoma (salivary gland adenocarcinoma, lacrimal gland adenocarcinoma, adenocarcinoma of unknown primary in the neck), cervical cancer, ovarian cancer and adenocarcinoma of unknown primary. Breast cancer is excluded.\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n4. Confirmed HER2 expression defined as IHC 1+, 2+ or 3+ (per GC criteria).\n5. Willing and able to provide adequate tumor specimens for central pathological re-testing of HER2 status. For participants previously treated with anti-HER2 therapy, tumor specimens obtained after the last anti-HER2 treatment are optional.\n6. At least one measurable lesion at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n7. Adequate organ and bone marrow function within 14 days prior to enrollment, meeting the following criteria:\n\n   Hemoglobin ≥ 9 g\u002FdL; Platelet count ≥ 100,000\u002Fmm³; Absolute neutrophil count (ANC) ≥ 1500\u002Fmm³; Serum albumin ≥ 3.0 g\u002FdL; Prothrombin time (PT), activated partial thromboplastin time (aPTT) and International Normalized Ratio (INR) ≤ 1.5 × upper limit of normal (ULN); Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 × ULN; ≤ 5 × ULN for participants with liver metastases; Total bilirubin ≤ 1.5 × ULN for participants without liver metastases; ≤ 3 × ULN for participants with Gilbert's syndrome or liver metastases at baseline; Creatinine clearance ≥ 30 mL\u002Fmin (calculated by the Cockcroft-Gault formula)\n8. Left ventricular ejection fraction (LVEF) ≥ 50% assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days prior to enrollment.\n\nExclusion Criteria:\n\nParticipants meeting any of the following conditions are ineligible for this study:\n\n1. Presence of any severe and\u002For uncontrolled diseases:\n\n   * Poorly controlled blood pressure (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); poorly controlled diabetes (fasting blood glucose \\[FBG\\] \\> 10 mmol\u002FL).\n   * Grade ≥ 2 myocardial ischemia, myocardial infarction, arrhythmia (QTc interval ≥ 470 ms), or Grade ≥ 2 congestive heart failure (per New York Heart Association \\[NYHA\\] classification).\n   * Active or uncontrolled severe infections (Grade ≥ 2 per NCI CTCAE) requiring systemic antibacterial, antifungal or antiviral therapy, including pulmonary tuberculosis.\n   * History of active tuberculosis.\n   * Uncontrolled ascites, pericardial effusion or pleural effusion requiring repeated drainage.\n2. Active hepatitis: Liver function not meeting the inclusion criteria. Hepatitis B: HBV DNA ≥ 2000 IU\u002FmL or ≥ 10\\^4 copies\u002FmL.Hepatitis C: HCV RNA ≥ 2000 IU\u002FmL or ≥ 10\\^4 copies\u002FmL. Participants with viral load below the above thresholds after nucleoside antiviral therapy are eligible. Chronic hepatitis B virus carriers with HBV DNA \\\u003C 10\\^4 IU\u002FmL must receive concurrent antiviral treatment throughout the study for enrollment.\n3. History of immunodeficiency diseases, including HIV positivity or other acquired\u002Fcongenital immunodeficiency disorders.\n4. History of allogeneic solid organ transplantation or allogeneic hematopoietic stem cell transplantation.\n5. Confirmed meningeal metastasis, spinal cord metastasis or spinal cord compression.\n6. Within 6 months prior to the first study drug administration, presence of esophageal gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, acute gastrointestinal bleeding, extensive intestinal resection (partial colectomy or extensive small bowel resection complicated with chronic diarrhea), Crohn's disease, ulcerative colitis or long-standing chronic diarrhea.\n7. Unhealed or poorly healing wounds, or active ulcers.\n8. Toxicities from prior anti-tumor therapy have not resolved to Grade 0 or 1 per NCI CTCAE version 5.0.\n9. Received major surgery, incisional biopsy or significant traumatic injury within 28 days before study treatment initiation; or with long-standing unhealed wounds or fractures.\n10. History of severe hypersensitivity reactions to monoclonal antibodies; known allergy to the active ingredients or excipients of the study drug.",{"count":621,"type":20},15,[24],"The goal of this clinical trial is to learn if Trastuzumab Rezetecan can treat advanced solid tumors with HER-2 expression in adult participants.\n\nThe main question it aims to answer is: What is the objective response rate of Trastuzumab Rezetecan in adult patients with HER-2 expressed advanced solid tumors? Participants will receive intravenous infusion of Trastuzumab Rezetecan on Day 1 of each 21-day treatment cycle. The dosage is 4.8 mg\u002Fkg per cycle; participants with a body weight of 85 kg or above will receive a fixed dose of 408 mg every 3 weeks.",[599,625,626,627,628,629,630,631,29,602,603,30,245,632,604,605],"Neoplasms (Cancer \u002F Tumors)","Advanced Malignant Solid Neoplasm","Locally Advanced Malignant Solid Neoplasm","Unresectable Malignant Solid Neoplasm","Metastatic Malignant Solid Neoplasm","HER2 Expression","Biliary Tract Neoplasms","Non-Small Cell Lung Carcinoma (NSCLC)",[634,635,636],"HER2 expression","Trastuzumab Rezetecan","Advanced Solid Tumor",{"date":285,"type":37},{"date":282,"type":20},{"date":74,"type":20},{"name":614,"class":194},{"id":642,"slug":4,"hasResults":11,"nctId":643,"briefTitle":644,"officialTitle":645,"acronym":646,"eligibilityCriteria":647,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":648,"targetDuration":4,"studyType":21,"phases":650,"briefSummary":651,"conditions":652,"keywords":653,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":656,"startDateStruct":657,"completionDateStruct":658,"leadSponsor":660,"locationsCount":662},"100458748","NCT05253651","A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer","An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer","MOUNTAINEER-03","Inclusion Criteria:\n\n* Histologically and\u002For cytologically confirmed adenocarcinoma of the colon or rectum which is locally advanced unresectable or metastatic\n* Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides) obtained prior to treatment initiation to a central laboratory\n\n  * If archival tissue is not available, a newly-obtained baseline biopsy of an accessible tumor lesion is required within 35 days prior to start of study treatment\n* HER2+ disease as determined by a tissue based assay performed at a central laboratory.\n* Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as determined by local or central testing. For central RAS analysis, tissue sample must be analyzed within 1 year of biopsy date.\n* Radiographically measurable disease per RECIST v1.1 with:\n\n  * At least one site of disease that is measurable and that has not been previously irradiated, or\n  * If the participant has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* CNS Inclusion - based on contrast brain magnetic resonance imaging, participants may have any of the following:\n\n  * No evidence of brain metastases\n  * Previously treated brain metastases which are asymptomatic\n\nExclusion Criteria:\n\n* Prior systemic anticancer therapy for colorectal cancer (CRC) in the locally advanced unresectable or metastatic setting; note that participants may have received a maximum of 2 doses of mFOLFOX6 in the locally advanced\u002Funresectable or metastatic setting prior to randomization.\n\n  * Note: May have received chemotherapy for CRC in the adjuvant setting if it was completed \\>6 months prior to enrollment\n* Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery)\n* Previous treatment with anti-HER2 therapy\n* Ongoing Grade 3 or higher neuropathy\n* Active or untreated gastrointestinal (GI) perforation at the time of screening.",{"count":649,"type":20},400,[454],"This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.\n\nParticipants in this study have colorectal cancer that has spread through the body (metastatic) and\u002For cannot be removed with surgery (unresectable).\n\nParticipants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either:\n\n* mFOLFOX6 alone,\n* mFOLFOX6 with bevacizumab, or\n* mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.",[30],[301,654,655],"CRC","Seattle Genetics",{"date":417,"type":37},{"date":397,"type":37},{"date":659,"type":20},"2030-07-03",{"name":661,"class":44},"Seagen, a wholly owned subsidiary of Pfizer",381,{"id":664,"slug":4,"hasResults":11,"nctId":665,"briefTitle":666,"officialTitle":667,"acronym":4,"eligibilityCriteria":668,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":669,"targetDuration":4,"studyType":21,"phases":671,"briefSummary":672,"conditions":673,"keywords":675,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":703,"lastUpdatePostDateStruct":704,"startDateStruct":705,"completionDateStruct":707,"leadSponsor":709,"locationsCount":109},"100639442","NCT07629960","A First-in-Human Trial of BLU-924 (SAR449336) in Advanced Solid Tumors Harboring KRAS Mutations","A Phase 1\u002F2, Open-Label, Dose-Escalation, Dose-Enrichment, and Dose-Expansion Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BLU-924 (SAR449336) as Monotherapy and Combination Therapy in Participants With Advanced Pancreatic Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer Harboring KRAS Mutations","Inclusion Criteria:\n\n1. Pathologically confirmed diagnosis of metastatic Kirsten rat sarcoma viral oncogene homolog (KRAS)-mutant pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), or colorectal cancer (CRC) with evidence of a single KRAS G12C, G12D, G12V, G12A, G12S, or G13D mutation in tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA).\n2. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.\n4. Patients must have received all standard therapies for their cancer type in the metastatic setting, unless they are unable to receive such therapies due to clinical characteristics, comorbidities, or other medically justified reasons.\n\nExclusion Criteria:\n\n1. History of additional malignancy within the last 2 years, with some exceptions as specified in the protocol.\n2. Active brain metastases (participants with asymptomatic brain metastases may be eligible).\n3. Have received prior targeted treatment(s) against KRAS, including pan-KRAS inhibitors, multi-RAS inhibitors, mutant-selective KRAS inhibitors, and RAS or KRAS degraders.\n4. Active or uncontrolled systemic infection, such as tuberculosis, Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV).\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",{"count":670,"type":20},265,[23,24],"A first in human study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of BLU-924 \u002F SAR449336, a pan-KRAS inhibitor, in participants with advanced Pancreatic Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer harboring KRAS mutations.",[636,674,30,415],"Non-Small Cell Lung Cancer",[676,677,678,679,680,681,682,683,684,685,686,687,688,689,690,691,216,692,693,694,220,695,696,697,219,698,699,700,217,212,701,702],"Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation","Metastatic Non-Small Lung Cell Cancer","Metastatic Colorectal Cancer (CRC)","Metastatic Pancreatic Ductal Adenocarcinoma","KRAS G12A","KRAS G12C","KRAS G12D","KRAS G12S","KRAS G12V","Solid Tumor, Adult","KRAS-mutant","KRAS-positive","KRAS G13D","Pan-KRAS inhibitor","KRAS inhibitor","First-in-human","Advanced cancer","Adult solid tumor","Metastatic solid tumor","Colon cancer","Rectal cancer","Metastatic colorectal cancer","Pancreatic ductal adenocarcinoma","PDAC","Metastatic pancreatic cancer","Precision oncology","Targeted therapy","2026-06-01",{"date":437,"type":37},{"date":706,"type":20},"2026-06-30",{"date":708,"type":20},"2031-07",{"name":710,"class":44},"Blueprint Medicines Corporation",{"id":712,"slug":4,"hasResults":11,"nctId":713,"briefTitle":714,"officialTitle":715,"acronym":716,"eligibilityCriteria":717,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":718,"targetDuration":719,"studyType":242,"phases":4,"briefSummary":720,"conditions":721,"keywords":724,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":730,"lastUpdatePostDateStruct":731,"startDateStruct":732,"completionDateStruct":733,"leadSponsor":735,"locationsCount":737},"100617475","NCT07319104","Liquid Biopsy in Early Colorectal Lesions","Biobank for Validating Liquid Biopsy in Predicting the Prognosis of Superficial Colonic Lesions","FECCO-BioBank","Inclusion Criteria:\n\n* Patient of legal age (≥ 18 years)\n* Patient with a superficial colonic tumor refered for submucosal dissection\n* Patient included in the FECCo cohort (patients will be included concomitantly in FECCO-Biobank)\n* Patient wishing to participate in the FECCO-BioBank biological collection\n\nExclusion Criteria:\n\n* Person with significant comorbidities preventing blood sampling\n* Patients with a distant metastasis detected by imaging\n* Person unable to read and write French\n* Person who have expressed their opposition to participating in this research after being informed by an investigator and having read the information sheet\n* Person not benefiting from a national health insurance scheme\n* Person under legal protection, guardianship or curatorship\n* Person participating in other study with an ongoing exclusion period",{"count":472,"type":20},"3 Months","Early colorectal cancer screening increasingly detects small superficial colonic lesions, but current diagnostic tools still struggle to distinguish benign from malignant lesions and to assess lymph node risk. As histology after resection has limited accuracy, many patients undergo unnecessary surgery.\n\nLiquid biopsy, analyzing circulating biomarkers such as tumor DNA, extracellular vesicles, and nucleosomes, offers a non-invasive way to better classify these lesions. Emerging evidence suggests it may outperform current criteria for predicting lymph node involvement in T1 colorectal cancer.\n\nThis study will establish a biobank of 1,000 patients to identify blood-based signatures that predict tumor stage and lymph node status. The hypothesis of the study is that circulating biomarkers can accurately differentiate benign from malignant lesions and identify patients with or without lymph node metastasis.",[30,722,723],"Precancerous Conditions","Adenocarcinoma of the Colon",[725,726,727,728,729],"Lymphatic Metastasis","Endoscopy, Gastrointestinal","Liquid Biopsy","Biomarkers","Biobanking","2026-05-29",{"date":420,"type":37},{"date":282,"type":20},{"date":734,"type":20},"2031-12-15",{"name":736,"class":194},"University Hospital, Montpellier",12,""]