[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastrointestinal-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastrointestinal-neoplasms":637},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,40,83,111,146,172,199,240,267,286,390,416,440,464,496,516,547,585,610],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100567064",false,"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","ALL","18 Years",{"count":18,"type":19},260,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","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.",[25,26],"Colorectal Neoplasms","Gastrointestinal Neoplasms","RECRUITING","2026-06-19",{"date":30,"type":31},"2026-06-24","ACTUAL",{"date":33,"type":31},"2024-10-15",{"date":35,"type":19},"2028-07-19",{"name":37,"class":38},"Janssen Research & Development, LLC","INDUSTRY",11,{"id":41,"slug":4,"hasResults":10,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":20,"phases":49,"briefSummary":51,"conditions":52,"keywords":61,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100641147","NCT07658313","Digitally Supported Prehabilitation Before Major Visceral Cancer Surgery","From Prehabilitation to Rehabilitation: A Feasibility Trial for Digitally Supported Prehabilitation in Major Visceral Oncologic Surgery","P2R-OncoVis","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Clinical diagnosis requiring major surgery of the pancreas, liver, bile ducts, stomach, or esophagus with curative intent\n* Confirmed indication for surgery by the multidisciplinary tumor board\n* Medical stability and physician clearance to participate in a prehabilitation exercise program\n* Willingness and ability to attend center-based prehabilitation exercise sessions three times per week, or once per week with additional tele-prehabilitation if travel time exceeds 40 minutes one way\n* Willingness and ability to perform home-based physical activities\n* Sufficient German language proficiency and digital literacy\n* Access to a smartphone or tablet device with internet connection\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Physical disability or mental impairment preventing safe participation in the study\n* Health care medical power of attorney not permitting independent consent\n* Non-elective, emergency, or revision surgery\n* Acute medical condition contraindicating participation in a structured prehabilitation program",{"count":48,"type":19},30,[50],"NA","Major visceral oncologic surgery is associated with high postoperative morbidity, prolonged hospitalization, delayed recovery, and reduced quality of life. Patients undergoing surgery of the pancreas, liver, bile ducts, stomach, or esophagus frequently present with reduced physical fitness, malnutrition, sarcopenia, and psychological distress, all of which may negatively affect surgical outcomes and rehabilitation. Although prehabilitation has shown potential to improve functional capacity before surgery, structured prehabilitation pathways are currently not routinely implemented in Austria, and the feasibility of digitally supported perioperative care pathways remains insufficiently evaluated.\n\nThe aim of the Prehab2Rehab-OncoVis study is to evaluate the feasibility, acceptability, and safety of a multimodal, digitally supported prehabilitation intervention for patients undergoing major visceral oncologic surgery with curative intent. The study will additionally explore potential effects on clinical recovery, functional capacity, rehabilitation outcomes, and patient-reported outcomes across the perioperative pathway.\n\nPrehab2Rehab-OncoVis is designed as a prospective, single-arm feasibility cohort study conducted at the University Hospital Salzburg and the University Institute of Sports Medicine, Prevention and Rehabilitation, coordinated by the Paracelsus Medical University in cooperation with the Ludwig Boltzmann Institute for Rehabilitation Research and the Ludwig Boltzmann Institute for Digital Health and Prevention within the Prehab2Rehab consortium. Approximately 30 adult patients, with the possibility to include up to 50 participants if feasible, will be consecutively recruited.\n\nThe intervention consists of a four-week multimodal prehabilitation program combining supervised exercise training, promotion of physical activity, nutritional counseling, psycho-oncological distress screening, and health literacy support. Digital tools will support the intervention throughout the perioperative pathway, including the HERO application (Das Herz Reha-Informationstool) for patient education and health literacy, aktivplan as a digital exercise planner and training diary, and the CAATS telecommunication platform for remote supervision and tele-prehabilitation sessions where appropriate.\n\nThe exercise intervention includes supervised center-based sessions and, for participants with longer travel distances, a hybrid model combining center-based and tele-prehabilitation sessions. Nutritional counseling will follow current European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines and includes screening for malnutrition risk. Psycho-oncological distress screening will follow recommendations of the German Cancer Society and includes referral to supportive care when clinically indicated.\n\nParticipants will be assessed throughout the perioperative pathway, including at the beginning and end of prehabilitation (Prehabilitation Assessment 1 \\[PRE1\\] and Prehabilitation Assessment 2 \\[PRE2\\]), during hospitalization and rehabilitation, and at a three-month follow-up after surgery. Primary outcomes focus on feasibility, including recruitment and retention rates, adherence, fidelity, safety, data management feasibility, and acceptability and usability of the digital technologies. Secondary outcomes include clinical recovery indicators, postoperative complications, length of hospital and intensive care stay, functional independence, psychological well-being, quality of life, body composition, cardiorespiratory fitness, functional exercise capacity, and muscle strength.\n\nTo contextualize outcomes, two historical comparator cohorts will be used: a local hospital cohort of patients who previously underwent similar surgery without prehabilitation, and a national rehabilitation cohort derived from routine rehabilitation datasets matched for diagnosis, sex, and age.\n\nThe study is intended to generate feasibility data and preliminary estimates that may support the development of future adequately powered randomized controlled trials evaluating digitally supported prehabilitation and rehabilitation pathways in visceral oncologic surgery.",[26,53,54,55,56,57,58,59,60],"Pancreatic Neoplasms","Liver Neoplasm","Oesophageal Cancer","Gastrointestinal Cancer","Pancreatic Cancer","Liver Cancer","Prehabilitation","Cancer Rehabilitation",[59,62,63,64,65,66,67,68,69,70],"Visceral Surgery","Oncology","Rehabilitation","Digital Health","Exercise Therapy","Teleprehabilitation","Cancer Surgery","Preoperative Care","Functional Recovery","NOT_YET_RECRUITING","2026-06-16",{"date":74,"type":31},"2026-06-18",{"date":76,"type":19},"2026-06",{"date":78,"type":19},"2027-07",{"name":80,"class":81},"Ludwig Boltzmann Institute for Digital Health and Prevention","OTHER",2,{"id":84,"slug":4,"hasResults":10,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":20,"phases":91,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100609772","NCT07218926","A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy","A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) Versus Sunitinib in Participants With Metastatic and\u002For Unresectable Gastrointestinal Stromal Tumors (GIST) After Imatinib Therapy (StrateGIST 3)","Inclusion Criteria:\n\n* Participants with histologically or cytologically confirmed GIST that is metastatic and\u002For surgically unresectable.\n* Documented disease progression on or intolerance to imatinib administered for first-line treatment of unresectable\u002Fmetastatic disease.\n* Documented mutation status of KIT and\u002For PDGFRA using a tissue based next-generation sequencing or polymerase chain reaction (PCR) assay.\n* Tumor tissue must be available for retrospective biomarker analysis. Sample may be archival or new biopsy.\n\nExclusion Criteria:\n\n* GIST that is both KIT and PDGFRA wild-type or known to harbor an activating PDGFRA exon 18 mutation.\n* Known untreated or active central nervous system metastases.\n* Participants with a known allergy or hypersensitivity to any component of IDRX-42 (GSK6042981) or sunitinib. Participants with a history of Stevens-Johnson syndrome on a prior Tyrosine kinase inhibitor (TKI) are excluded.\n* Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas (e.g., breast, cervix, bladder) that have been resected with no evidence of metastatic disease.",{"count":90,"type":19},450,[92],"PHASE3","The purpose of this study is to find out if a new drug, called IDRX-42 (also known as GSK6042981), is effective in treating adults with a type of cancer called Gastrointestinal Stromal Tumors (GIST) when compared to another drug named sunitinib. The study will see if IDRX-42 works well and is safe for participants whose GIST has spread or cannot be surgically removed, and who have already taken the drug imatinib. Participants whose disease worsens after receiving sunitinib in this study may cross over to receive GSK6042981, at investigator's discretion and if additional eligibility criteria are met.",[26],[96,97,98,99,100],"GSK6042981","IDRX-42","Sunitinib","Imatinib","Gastrointestinal Stromal Tumors","2026-06-10",{"date":103,"type":31},"2026-06-12",{"date":105,"type":31},"2025-12-03",{"date":107,"type":19},"2030-11-29",{"name":109,"class":38},"GlaxoSmithKline",124,{"id":112,"slug":4,"hasResults":10,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":20,"phases":119,"briefSummary":120,"conditions":121,"keywords":130,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":145},"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":118,"type":19},800,[92],"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.",[122,26,123,124,125,126,127,128,129,25],"Intestinal Neoplasms","Digestive System Neoplasms","Neoplasms by Site","Digestive System Diseases","Gastrointestinal Diseases","Colonic Diseases","Intestinal Diseases","Rectal Diseases",[131,132,133,134,135],"mCRC","metastatic disease","first-line","metastatic colorectal cancer","colon cancer","2026-06-03",{"date":138,"type":31},"2026-06-04",{"date":140,"type":31},"2025-12-11",{"date":142,"type":19},"2031-08-01",{"name":144,"class":38},"Pfizer",228,{"id":147,"slug":4,"hasResults":10,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":20,"phases":154,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":171},"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":153,"type":19},280,[92],"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.",[25,157,122,26,123],"Neoplasm Metastasis",[159,160,161,162],"FOLFIRI","CPT-11","Bevacizumab","2nd-line metastatic colorectal cancer",{"date":164,"type":31},"2026-06-05",{"date":166,"type":31},"2011-11-14",{"date":168,"type":19},"2026-12-31",{"name":170,"class":81},"Sun Yat-sen University",1,{"id":173,"slug":4,"hasResults":10,"nctId":174,"briefTitle":175,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":177,"targetDuration":179,"studyType":180,"phases":4,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":198},"100637149","NCT07605702","The Canopy Cancer Collective Clinical Registry Protocol","Inclusion Criteria:\n\nRetrospective Cohort:\n\n1. Must have reached the age of majority in the jurisdiction where enrolled (18 years; Alabama\u002FNebraska 19; Puerto Rico 21).\n2. Must have histologically proven GI cancer seen at the site within the 20 years preceding activation, and are:\n\n   1. Deceased, or\n   2. Lost to follow-up ( \\>1 year lapse in contact since last visit).\n\nProspective Cohort:\n\n1. Must have reached the age of majority in the jurisdiction where enrolled (18 years; Alabama\u002FNebraska 19; Puerto Rico 21).\n2. Must have histologically proven Gastrointestinal (GI) cancer.\n3. Patient or legally authorized representative capable of understanding and willing to provide signed informed consent (assent if applicable).\n4. Patient\u002FLegally Authorized Representative (LAR) agrees to collection of clinical data and information available on archival tissue and subsequent excess specimens obtained as part of standard-of-care.\n\nExclusion Criteria:\n\nRetrospective Cohort:\n\n1\\. Cases in which patient's medical chart denotes restricted use of health information.\n\nProspective Cohort:\n\n1\\. Prisoners will not be approached for participation.",{"count":178,"type":19},100000,"2 Years","OBSERVATIONAL","The Canopy Cancer Collective Clinical Registry Protocol Non-Interventional Data and Sample Collection Registry Protocol\n\nNumber of study sites 15 Study Design - Observational, registry Primary Objective To systematically collect and store comprehensive data on gastrointestinal cancer patients, encompassing both their past medical history and future clinical experiences, to address specific future research questions related to these malignancies, to establish and share best practices, and to support quality improvement initiatives focused on enhancing patient care and outcomes.\n\nSecondary Objective(s) 1. Leverage the collective to increase access to molecular profile and biomarker (ctDNA) matched clinical trials across the treatment trajectory.\n\n2\\. Use real world data and patient reported outcomes to improve patient care throughout the treatment trajectory.\n\nResearch Procedure(s) Collection of clinical and outcome data and cataloging and facilitating access to physical biological specimens and their associated data for future research purposes.\n\nDrugs\u002FDevices used on Study None Study Population Patients with diagnosis of gastrointestinal (GI) cancers who seek care at one of the canopy centers and\u002For their affiliates Sample Size Up to 30000 patients in the prospective component\n\nUp to 70000 subjects will be enrolled on the retrospective component Study Duration for Individual Participants Anticipated to be at least 1 year Study Specific Abbreviations AE: Adverse Event CEC: Clinical Events Committee CT: Computed Tomography iCCA: Intrahepatic cholangiocarcinoma MRI: Magnetic Resonance Imaging OS: Overall Survival PFS: Progression Free Survival",[26,57,183,184,185,186,187],"Colorectal Cancer","GI Cancers","PDAC - Pancreatic Ductal Adenocarcinoma","PDAC","GI Cancer","2026-05-18",{"date":190,"type":31},"2026-05-26",{"date":192,"type":19},"2026-05",{"date":194,"type":19},"2038-05",{"name":196,"class":197},"Canopy Cancer Collective, LLC","NETWORK",10,{"id":200,"slug":4,"hasResults":10,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":20,"phases":208,"briefSummary":210,"conditions":211,"keywords":214,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":171},"100637558","NCT07586813","Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gastrointestinal Solid Tumors","A Prospective, Randomized, Open-Label, Controlled Study of Romiplostim N01 Combined With All-Trans Retinoic Acid Versus Romiplostim N01 Alone for Persistent Isolated Chemotherapy-Induced Thrombocytopenia in Patients With Complete Remission of Gastrointestinal Solid Tumors","N01-A-PICIT-GI","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Prior diagnosis of a gastrointestinal\u002Fdigestive system solid tumor, including but not limited to gastrointestinal tract, pancreatic, or colorectal cancer.\n3. Complete remission of the underlying tumor after chemotherapy or antitumor treatment, with tumor-related treatment discontinued for at least 12 weeks before enrollment, no evidence of recurrence or progression by specialist assessment, and no current need for additional tumor-directed therapy.\n4. Persistent isolated chemotherapy-induced thrombocytopenia, defined as platelet count \\\u003C30 x 10\\^9\u002FL on two peripheral blood tests at least 7 days apart; or platelet count slightly higher than 30 x 10\\^9\u002FL with dependence on platelet transfusion to maintain a safe platelet level.\n5. Thrombocytopenia has persisted since the last chemotherapy treatment without a clear trend of spontaneous recovery.\n6. Red blood cell count and neutrophil count are generally preserved, without clinically significant anemia or neutropenia.\n7. Bone marrow assessment performed within 1 year after tumor diagnosis and chemotherapy shows no tumor cell infiltration; megakaryocyte count is normal or increased, with or without maturation impairment.\n8. No hepatosplenomegaly, portal hypertension, or other evidence suggesting abnormal platelet redistribution as the main cause of thrombocytopenia.\n9. Prior treatment with at least one thrombopoietin receptor agonist or recombinant human thrombopoietin for PICIT without response, defined as failure of platelet count to rise to a safe level or to at least 2 times baseline after at least 2 weeks of standard-dose treatment.\n10. No prior use of Romiplostim N01.\n11. Other platelet-raising medications have been discontinued before enrollment. No washout period is required for prior thrombopoietin receptor agonists; other investigational drugs or off-label treatments must be discontinued for at least 1 month before enrollment.\n12. Ability to understand and sign the informed consent form and willingness to comply with study visits and procedures.\n13. Women of childbearing potential must have a negative pregnancy test before enrollment and agree to use effective contraception during study treatment.\n\nExclusion Criteria:\n\n1. Other hematologic diseases that may affect hematopoiesis or cause thrombocytopenia, including but not limited to aplastic anemia, myelodysplastic syndrome, leukemia or other hematologic malignancies, or a clear history of primary immune thrombocytopenia.\n2. Active recurrence or progression of the underlying tumor, or evidence of bone marrow metastasis or tumor cell infiltration on bone marrow examination.\n3. Uncontrolled chronic viral infection, including hepatitis B, hepatitis C, or HIV infection, or active severe infection at screening or within 4 weeks before screening.\n4. Severe cardiac, hepatic, renal, or other organ dysfunction, or any serious organic disease that would make the participant unable to tolerate study treatment.\n5. Pregnancy or breastfeeding.\n6. Known severe hypersensitivity to Romiplostim, Romiplostim N01, ATRA, or any component of the study drugs.\n7. Prior Romiplostim treatment associated with severe adverse reactions or lack of efficacy.\n8. Poor compliance, inability to complete treatment or follow-up, psychiatric or psychological condition that prevents understanding of the study procedures, or any other condition that, in the investigator's judgment, may increase study risk or interfere with interpretation of study results.",{"count":207,"type":19},220,[209],"PHASE2","This is a prospective, randomized, open-label, active-controlled study to evaluate the efficacy and safety of Romiplostim N01 plus all-trans retinoic acid (ATRA) compared with Romiplostim N01 alone in adults with persistent isolated chemotherapy-induced thrombocytopenia (PICIT) after complete remission of gastrointestinal\u002Fdigestive system solid tumors, including but not limited to gastrointestinal tract, pancreatic, and colorectal cancers.\n\nEligible participants will be randomized in a 1:1 ratio to receive Romiplostim N01 plus oral ATRA or Romiplostim N01 alone for 12 weeks, with follow-up through Week 24. The primary outcome is the overall platelet response rate at Week 12, defined as platelet count \\>50 x 10\\^9\u002FL in at least 2 of the last 3 scheduled platelet assessments up to Week 12. Secondary outcomes include sustained response during Weeks 13 to 24, complete and partial response rates, duration of response, time to response, platelet count changes, platelet transfusion requirements, bleeding events, and safety.",[212,213,26,57,183],"Persistent Isolated Chemotherapy-Induced Thrombocytopenia","Chemotherapy-Induced Thrombocytopenia",[215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230],"PICIT","Persistent isolated chemotherapy-induced thrombocytopenia","CIT","Chemotherapy-induced thrombocytopenia","Romiplostim N01","ATRA","All-trans retinoic acid","Tretinoin","Thrombopoietin receptor agonist","Gastrointestinal solid tumor","Digestive system cancer","Pancreatic cancer","Colorectal cancer","Complete remission","Platelet response","Thrombocytopenia","2026-05-08",{"date":233,"type":31},"2026-05-14",{"date":235,"type":31},"2025-12-22",{"date":237,"type":19},"2027-12-31",{"name":239,"class":81},"Peking University People's Hospital",{"id":241,"slug":4,"hasResults":10,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":20,"phases":248,"briefSummary":250,"conditions":251,"keywords":256,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":263,"leadSponsor":265,"locationsCount":171},"100622892","NCT07389525","Immune Checkpoint Inhibitor (ICI)-Drug-Drug Interaction (DDI) Study","Assessment of Drug-Drug Interactions Between Immune Checkpoint Inhibitors and Cytochrome P450 Substrates: Immune Checkpoint Inhibitor (ICI)-Drug-Drug Interaction (DDI) Study","Inclusion Criteria:\n\n* ≥ 18 years old at the time of informed consent\n* Diagnosed with cancer AND initiating therapy with single agent or combination therapy that includes an immune checkpoint inhibitor (e.g., atezolizumab, cemiplimab, durvalumab, ipilimumab, nivolumab, pembrolizumab, relatlimab, tremelimumab)\n* Ability to provide written informed consent and HIPAA authorization\n\nExclusion Criteria:\n\n* Actively pregnant or breastfeeding\n* Body weight less than 50 kg or a BMI \\>35\n* Low baseline hemoglobin, defined as \\\u003C10 g\u002FdL\n\n  * Note: if a prospective patient's hemoglobin returns to the normal range, they can be re-screened for trial inclusion)\n* Past medical history of chronic liver disease, signs and symptom of liver disease (e.g., jaundice, ascites), or aspartate aminotransferase \\>96 U\u002FL, alanine aminotransferase \\> 80 IU\u002FL, alkaline phosphatase \\>260 U\u002FL, or total bilirubin \\> 2.6 mg\u002FdL\n\n  * Note: if a prospective patient's liver function tests return to the normal ranges, they can be re-screened for trial inclusion)\n* Past medical history of chronic kidney disease, signs and symptom of kidney disease (e.g., decreased urine output, swelling in feet and ankles), or estimated glomerular filtration rate \\\u003C45 mL\u002Fminute\u002F1.73 m2 BSA\n\n  * Note: if a prospective patient's kidney function returns to the normal range, they can be re-screened for trial inclusion)\n* Poor performance status that makes it unlikely the patient will complete 3 cycles of immune checkpoint inhibitor (at the treating oncologist's discretion)\n* Diagnosis or past medical history of autoimmune disorder, including systemic lupus erythematosus, Crohn's disease, Sjogren's syndrome, multiple sclerosis, type 1 diabetes mellitus, Behcet's disease, and ankylosing spondylitis\n* History of intolerance, allergic reaction, or hypersensitivity to any of the study drugs (tizanidine, bupropion, flurbiprofen, omeprazole, dextromethorphan, midazolam, rosuvastatin)\n* Current infection requiring medical treatment (note: if a prospective patient's infection resolves, they can be re-screened for trial inclusion)\n* Concomitant treatment with systemic immunosuppressant drugs (see Appendix 3 for list)\n\n  * Note: patients may be re-screened for trial eligibility if they discontinue any exclusionary drugs for ≥7 days prior to Study Visit 1\n* Concomitant treatment with a CYP\u002Ftransporter probe cocktail drug or strong inhibitors, inducers, or agents that affect the pharmacokinetics of the relevant CYP enzymes or drug transporters (see Appendix 4 for list)\n\n  * Note: patients may be re-screened for trial eligibility if they discontinue any exclusionary drugs for ≥7 days prior to Study Visit 1\n* Are unwilling\u002Funable to avoid drugs of abuse, tobacco products or marijuana, or consuming more than 2 alcoholic drinks per day during the study\n* Inability to take oral medication",{"count":247,"type":19},80,[249],"EARLY_PHASE1","Immune checkpoint inhibitors (ICIs) (also called \"immunotherapy\") are an effective family of anti-cancer drugs, but they can cause serious side effects. Some evidence suggests these side effects might happen because ICIs interact with other drugs that you may already be taking, making those drugs work differently, or causing more side effects. The purpose of this study is to see whether ICIs impact how the liver processes other drugs. To do this, participants will be given a probe cocktail of 7 different FDA-approved drugs that are processed in different ways in the liver.",[26,252,253,254,255],"Genitourinary Cancer","Thoracic Cancer","Sarcoma","Melanoma",[257,258],"cytokines","immune checkpoint inhibitor","2026-04-21",{"date":261,"type":31},"2026-04-24",{"date":76,"type":19},{"date":264,"type":19},"2027-12",{"name":266,"class":81},"Indiana University",{"id":268,"slug":4,"hasResults":10,"nctId":269,"briefTitle":270,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":180,"phases":4,"briefSummary":274,"conditions":275,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":171},"100190123","NCT01750619","Clinical Outcomes of the Endoscopic Resection of Premalignant and Malignant Gastrointestinal Lesions","Inclusion Criteria:\n\n* Patients age \\>18 years that have been referred for endoscopic treatment of GI lesions.\n\nExclusion Criteria:\n\n* Patients for whom endoscopic treatment was not performed.",{"count":273,"type":19},8000,"To evaluate clinical outcome for patients receiving treatment of suspected premalignant and malignant gastrointestinal lesions at Interventional Endoscopy Services. The primary outcome is curative endoscopic resection. Secondary outcomes include resection technique utilized, rates of en bloc resection and adverse event rates, including infection, bleeding, perforation and death, and one-year survival rates.",[26,276],"Benign Neoplasm of Intestinal Tract","2026-03-20",{"date":279,"type":31},"2026-03-23",{"date":281,"type":4},"2011-07",{"date":283,"type":19},"2030-12",{"name":285,"class":81},"California Pacific Medical Center Research Institute",{"id":287,"slug":4,"hasResults":10,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":292,"enrollmentInfo":293,"targetDuration":4,"studyType":20,"phases":295,"briefSummary":296,"conditions":297,"keywords":375,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":171},"100432171","NCT04907643","Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes","Randomized Controlled Trial of Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes","Inclusion Criteria:\n\n* Have a primary malignancy of the biliary tract, colon, liver, pancreas, peritoneum, rectum, small intestine, or stomach, with no plan for resection during the study period\n* Tumor types including, but not limited to, adenocarcinoma, squamous cell carcinoma, neuroendocrine tumors, and tumors of mesenchymal origin will be eligible\n* Have clinically significant visceral pain, measured using the standardized NIH PROMIS GI Pain Scale defined as scoring at least 5 points above the nationally normed score\n* Ability to read and write in English\n\nExclusion Criteria:\n\n* Have a condition that interferes with VR usage, including but not limited to seizures, facial injury precluding safe placement of headset, and visual impairments\n* Have cognitive impairment that affects protocol participation. This will be done with a three part cognitive assessment during the initial phone call to assess eligibility followed by consent discussion if eligible.\n* Have brain metastases\n* Have a prognosis of \\\u003C3 months from the time of enrollment per treating oncologist","99 Years",{"count":294,"type":19},360,[50],"Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of life (HRQOL). Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, three-dimensional worlds. To date, VR has been limited to short-term clinical trials for cancer pain. Moreover, limited research exists on theory-based VR modalities beyond mere distraction, such as VR that employs acceptance and commitment therapy (ACT) with components of biofeedback and mindfulness. To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients with visceral pain from a digestive tract malignancy; (2) assess differences in PROs, activity metrics, and opioid use between skills-based VR therapy vs. distraction VR therapy; and (3) determine patient-level predictors of VR treatment response in visceral cancer pain.\n\nTo address these aims, the study will measure PROs and opioid use in 360 patients randomized among 3 groups and follow them for 60 days after enrollment: (1) an enhanced VR group receiving skills-based VR; (2) a distraction-based VR group receiving patient-selected VR videos; and (3) a VR sham control group using a VR headset with 2-D content. The results will inform best practices for the implementation of VR for visceral cancer pain management and guide selection of patient-tailored experiences.",[298,299,26,300,301,302,58,303,304,305,306,307,308,309,310,311,312,313,314,315,316,317,318,319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374],"Cancer Pain","Visceral Pain","Cancer of Gastrointestinal Tract","Small Intestine Cancer","Pancreas Cancer","Colon Cancer","Biliary Tract Cancer","Stomach Cancer","Rectum Cancer","Peritoneal Cancer","Gastrointestinal Cancer Metastatic","Gastrointestinal Cancers - Anus","Gastrointestinal Cancers - Stomach","Gastrointestinal Cancers - Colorectal","Gastrointestinal Cancers - Small Intestine","Small Intestine Cancer Stage III","Small Intestine Cancer Stage IV","Small Intestine Cancer, Recurrent","Pancreas Cancer, Stage III","Pancreas Cancer, Stage IV","Pancreas Cancer, Metastatic","Pancreas Cancer, Recurrent","Liver Cancer Stage IIIa","Liver Cancer Stage IIIb","Liver Cancer Stage IIIc","Liver Cancer Stage IV","Colon Cancer Stage III","Colon Cancer Stage IV","Stomach Cancer Stage III","Stomach Cancer Stage IV","Stomach Cancer Recurrent","Rectum Cancer, Recurrent","Gastrointestinal Cancers - Liver","Anal Cancer","Anal Cancer Stage III","Anal Cancer Stage IV","Anal Cancer Recurrent","Anal Cancer Metastatic","Anal Cancer, Stage IIIA","Anal Cancer, Stage IIIB","Appendix Cancer","Ampullary Cancer","Bile Duct Cancer","Bile Duct Cancer Stage III","Bile Duct Cancer Stage IV","Bile Duct Cancer Stage IVA","Bile Duct Cancer Stage IVB","Bile Duct Cancer Recurrent","Carcinoid Tumor","Carcinoid Tumor of Pancreas","Carcinoid Tumor of Large Intestine","Carcinoid Tumor of GI System","Carcinoid Tumor of Colon","Carcinoid Tumor of Liver","Carcinoid Tumor of Cecum","Carcinoid Tumor of Ileum","Carcinoid Tumor of Rectum","Carcinoid Tumor of the Small Bowel","Carcinoid Tumor of the Stomach","Large Intestine Cancer","Esophagus Cancer","Esophagus Cancer, Stage III","Esophagus Cancer, Stage IV","Esophagus Cancer, Recurrent","Gallbladder Cancer","Gallbladder Cancer Stage III","Gallbladder Cancer Stage IV","Gastric (Stomach) Cancer","Neuroendocrine Tumor","Peritoneum Cancer","Rectal Cancer","Esophagus Cancer, Stage I","Esophagus Cancer, Stage II","Gallbladder Cancer Stage I","Gallbladder Cancer Stage II","Bile Duct Cancer Stage I","Bile Duct Cancer Stage II",[376,377,378,379,380],"Virtual Reality","VR","support","GI cancer","cancer pain","2026-02-18",{"date":383,"type":31},"2026-02-20",{"date":385,"type":31},"2021-10-05",{"date":387,"type":19},"2027-03-16",{"name":389,"class":81},"Cedars-Sinai Medical Center",{"id":391,"slug":4,"hasResults":10,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":20,"phases":398,"briefSummary":399,"conditions":400,"keywords":404,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":171},"100617495","NCT07319364","A Real-World Study of Fecal Transplants for Cancer Therapy Side Effects","An Observational, Real-World Study Evaluating Fecal Microbiota Transplantation for the Prevention\u002FReduction of Chemotherapy\u002FTargeted Therapy-Induced Gastrointestinal Symptoms in Patients With Gastrointestinal Cancers.","Inclusion Criteria:\n\n1. Age ≥ 18 years, gender not restricted;\n2. Estimated survival time ≥ 3 months;\n3. Confirmed diagnosis of gastrointestinal tumors by pathological examination, including esophageal cancer, gastric cancer, colon cancer, rectal cancer, etc.;\n4. TNM staging of cancer in patients is Stage IV;\n5. Having undergone PD-1 or PD-L1 testing;\n6. Planned to receive the 4th cycle of chemotherapy\u002Ftargeted therapy;\n7. Occurrence of gastrointestinal adverse reactions (including but not limited to diarrhea, constipation, vomiting, nausea, etc.) within 3 cycles of conventional chemotherapy\u002Ftargeted therapy;\n8. Patients are able and willing to sign the informed consent form and complete follow-up;\n9. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3;\n10. Use of oral\u002Fintravenous broad-spectrum antibiotics with caution within 3 days;\n11. Patients are able to swallow capsules without chewing;\n12. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3;\n13. Laboratory test results during the screening period indicate that the subjects have sufficient organ function.\n\nExclusion Criteria:\n\n1. Patients with major organ dysfunction or even failure, including but not limited to cardiac insufficiency or heart failure, renal insufficiency or renal failure, and hepatic insufficiency\u002Fhepatic failure;\n2. Uncontrolled or severe infections;\n3. Known history of psychotropic substance abuse, alcoholism, and drug abuse;\n4. Patients with severe infections complicated with septicemia or sepsis;\n5. Patients with a history of severe allergic reactions or a known allergy to the components of liquid live bacteria enteric-coated capsules;\n6. Patients with active viral infections;\n7. Female subjects with a positive pregnancy test, lactating female subjects, and women of childbearing age who refuse to use contraceptive measures during the entire observation period (15 weeks);\n8. Patients with gastrointestinal perforation and\u002For fistula;\n9. Other conditions deemed unsuitable for enrollment by the investigator.",{"count":397,"type":19},90,[22],"The goal of this clinical trial is to learn if fecal microbiota transplantation can treat in Gastrointestinal cancer patients with chemotherapy \u002F targeted gastrointestinal symptoms. The main question it aims to answer is: To evaluate the effect of fecal microbiota transplantation (FMT) on gastrointestinal tract in patients with gastrointestinal tumors.",[401,26,402,403],"Fecal Microbiota Transplantation (FMT)","Antineoplastic Agents","Drug-related Side Effects and Adverse Reactions",[405,26,402,406],"Fecal Microbiota Transplantation","Drug-Related Side Effects and Adverse Reactions","2025-12-21",{"date":409,"type":31},"2026-01-06",{"date":411,"type":31},"2025-09-01",{"date":413,"type":19},"2026-09-01",{"name":415,"class":81},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":417,"slug":4,"hasResults":10,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":423,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":180,"phases":4,"briefSummary":426,"conditions":427,"keywords":428,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":437,"locationsCount":171},"100434477","NCT04937647","Evaluation of Neoplasia With Artificial Intelligence in Gastrointestinal Endoscopy","Collection of Endoscopic Images and Videos for Validation of Artificial Intelligence Algorithms for Computer Aided Detection and Characterisation of Early Gastrointestinal Neoplasia","NEW-AGE","Inclusion Criteria:\n\n-The participant must meet ALL of the following criteria to be considered eligible for the study:\n\n* Male or Female, aged 18 years or above.\n* Requiring gastroscopy and\u002For colonoscopy to investigate gastrointestinal symptoms, or as part of screening or ongoing surveillance of GI neoplasia.\n* Participant is willing and able to give informed consent for participation in the study.\n\nExclusion Criteria\n\nThe participant may not enter the study if ANY of the following apply:\n\n* Patients with endoscopically active severe oesophagitis\n* Poor bowel preparation",true,{"count":425,"type":19},1650,"This study aims to validate and evaluate AI algorithms for detection and characterization of early GI neoplasia.",[26],[429,430],"gastrointestinal neoplasia","artificial intelligence","2025-12-16",{"date":433,"type":31},"2025-12-23",{"date":435,"type":31},"2021-06-16",{"date":136,"type":19},{"name":438,"class":439},"Portsmouth Hospitals NHS Trust","OTHER_GOV",{"id":441,"slug":4,"hasResults":10,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":20,"phases":448,"briefSummary":449,"conditions":450,"keywords":451,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":463},"100584107","NCT06885034","A Study to Test the Safety and Effectiveness of GSK5764227, Alone or With Other Treatments, in Participants With Advanced Gastrointestinal Cancers That Cannot be Surgically Removed","A Phase 1b\u002F2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of GSK5764227 Alone and in Combination in Participants With Previously Treated Advanced Unresectable or Metastatic Gastrointestinal Solid Tumors","Inclusion criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n• Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place years of age at the time of signing the informed consent form (ICF).\n\nCRC Cohort\n\n* Has histologically confirmed unresectable\u002F, locally advanced or unresectable metastatic adenocarcinoma of the colon or rectum (histology defined by World Health Organization (WHO) classification).\n* Must have received at least 1 and no more than 2 lines of systemic treatment for advanced colorectal cancer (CRC), with documented progression on most recent prior line of therapy.\n* Must provide tumor tissue from a newly obtained fresh biopsy or an archival tumor tissue.\n\nPDAC Cohort\n\n* Has histologically or cytologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the pancreas (histology defined by WHO classification).\n* Must have received 1 and no more than 1 line of therapy for advanced PDAC, with documented progression.\n* Should provide tumor tissue at screening, where available or medically feasible.\n\nAll Cohorts\n\n* Has at least 1 target lesion per RECIST 1.1, as determined by the investigator.\n* Is willing to use adequate contraception.\n* Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocol.\n* Has an ECOG performance status of 0 or 1.\n* Has adequate organ function.\n\nExclusion criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas \\[e.g., breast, cervix, bladder\\] that have been resected with no evidence of disease.\n* Has had any major surgery within 28 days prior to randomization (CRC Cohort) or first dose of study intervention (PDAC Cohort).\n* Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.\n* Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.\n* Has severe, uncontrolled or active cardiovascular disorders.\n* Has serious or poorly controlled hypertension.\n* Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.\n* Has serious infection within 4 weeks prior to the first dose.\n* Known active infectious diseases requiring systemic treatment or known Human immunodeficiency virus (HIV).\n* Has serious arteriovenous thromboembolic events (such as deep vein thrombosis, pulmonary embolism, etc.) within 3 months prior to the first dose.\n* Has untreated brain or Central nervous system (CNS) metastases or brain\u002FCNS metastases that have progressed.\n* Has current active pneumonitis or any history of pneumonitis requiring steroids or immunomodulatory treatment within 90 days of planned \\[randomization\\] or any history of drug-induced pneumonitis.\n* Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening.\n* Has any active renal condition (e.g., infection, requirement for dialysis, or any other significant renal condition that could affect the participant's safety).\n* Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to Grade 1 or to the baseline status preceding prior therapy.\n* Has any serious and\u002For unstable medical or psychiatric disorder or other condition(s) (including laboratory assessment abnormalities) that could interfere with the participant's safety, obtainment of informed consent, or compliance to the study procedures.\n* Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal\u002Fgastric varices, or persistent jaundice.\n* Has documented presence of Hepatitis B surface antigen (HBsAg) or HBcAb at screening or within 3 months prior to the first dose of study intervention.\n* Has a positive Hepatitis C virus (HCV) antibody test result at screening or within 3 months prior to the first dose of study intervention.\n* Has a positive HCV RNA test result at screening or within 3 months prior to the first dose of study intervention.\n* Has received immunosuppressive agents within 30 days prior to first dose of study intervention (or requires long-term \\[30 days or longer\\]).\n* Has received any prior therapy with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor payload.\n* Has received any live vaccine within 30 days of randomization (CRC Cohort) or before first dose of study intervention (PDAC Cohort).\n* Is currently enrolled or has participated in any other clinical study involving an investigational study intervention or any other type of interventional medical research and\u002For has received treatment with any anticancer or investigational agent within 4 weeks prior to randomization.\n* Is pregnant or breastfeeding.\n* Is unable to adhere to the protocol defined SoA, including requirements for the Follow-up Period of the study.",{"count":447,"type":19},320,[22,209],"This study will check how well a new medicine, GSK5764227, works, how safe it is and how the body handles it in participants all around the world with advanced inoperable or metastatic gastrointestinal cancer who have previously received treatment.",[26],[452,453,183,454],"GSK5764227","Solid Tumors","Pancreatic ductal adenocarcinoma","2025-11-17",{"date":457,"type":31},"2025-11-18",{"date":459,"type":31},"2025-06-11",{"date":461,"type":19},"2028-06-23",{"name":109,"class":38},47,{"id":465,"slug":4,"hasResults":10,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":20,"phases":472,"briefSummary":473,"conditions":474,"keywords":479,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":495},"100533194","NCT06222645","PPG vs. ICG in Gastrointestinal Resections","Comparison Between Fluorescenceimaging With Photoplethysmography （PPG） and Indocyaningreen (ICG) for Tissue Perfusion in Gastrointestinal Resections","Inclusion Criteria:\n\n* Adult patients (age ≥ 18 years).\n* Scheduled to undergo an elective gastrointestinal resection requiring a primary gastro-intestinal or entero-enteric anastomosis.\n* Able to understand and provide written informed consent.\n\nExclusion Criteria:\n\n* Known hypersensitivity or allergy to indocyanine green (ICG), iodine, or any component of the ICG formulation.\n* Severe hepatic impairment (e.g., Child-Pugh Class C).\n* Pregnancy or lactation.\n* Emergency surgery.\n* Inability to comply with the study protocol or follow-up schedule in the investigator's judgment.",{"count":471,"type":19},200,[50],"This randomized controlled trial compares a novel optical technique against the standard of care for assessing tissue perfusion in gastrointestinal surgery. Participants are randomized to receive either intraoperative imaging photoplethysmography (iPPG) or indocyanine green (ICG) fluorescence imaging. In the ICG group, the fluorescence data are comprehensively analyzed in two distinct ways: (1) Qualitative Assessment: real-time visual interpretation of the angiogram flow by the operating surgeon; and (2) Quantitative Assessment: software-based analysis of fluorescence kinetics (e.g., time-to-peak, maximum intensity) to generate objective perfusion parameters. The study aims to determine the agreement between the iPPG-based evaluations and both the qualitative and quantitative dimensions of the ICG standard.",[475,476,477,26,478,183],"Anastomosis","Perfusion","Postoperative Complications","Gastric Cancer (GC)",[480,481,482,483,484,485,486],"Photoplethysmography","Indocyanine Green","Fluorescence Imaging","Anastomotic Leak","Gastrointestinal Surgery","Tissue Perfusion","Intraoperative Monitoring","2025-11-14",{"date":457,"type":31},{"date":490,"type":31},"2023-11-01",{"date":492,"type":19},"2026-05-31",{"name":494,"class":81},"Saint Petersburg State University, Russia",3,{"id":497,"slug":4,"hasResults":10,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":502,"targetDuration":504,"studyType":180,"phases":4,"briefSummary":505,"conditions":506,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":171},"100573569","NCT06747988","Feasibility and Prospective Study of a Dynamic Traction Device for Use During ESD","Prospective Study Evaluating the Use of a Novel Through - the- Scope Suturing System as a Dynamic Traction Device During ESD: A Feasibility Study","Inclusion Criteria:\n\n1. The patient is ≥ 18 years old.\n2. Patients can provide informed consent.\n3. The patient is referred for ESD procedure of colonic or gastric neoplastic lesions and with one of the following criteria:\n\nA- Lesions with prior failed resection of any size. B- Granular lateral spreading tumors (GLST) more than 30 mm. C- Non granular lateral spreading tumors (NGLST) more than 20 mm. D- Any lesion with suspected superficial submucosal invasion. E- Subepithelial lesions.\n\nExclusion Criteria:\n\n1. The patient is \\\u003C 18 years old.\n2. The patient refuses and\u002For is unable to provide consent.\n3. The patient is a pregnant woman.\n4. Lesions with morphology: pedunculated type (Paris Ip, Ips).\n5. Appendiceal orifice or IC valve lesions\n6. Patients with lesions removed with other techniques besides ESD (submucosal tunneling technique \\[STER\\] or EMR).",{"count":503,"type":19},100,"1 Month","The goal of this prospective study at Baylor St. Luke's Medical Center is to investigate the the efficacy and safety of using the novel TTS helix tack suture device as a dynamic traction device during colon and gastric endoscopic submucosal dissection (ESD). The investigators of this study hypothesize that a dynamic traction during ESD can be less traumatic than with other traction devices.",[26],"2024-12-19",{"date":509,"type":31},"2024-12-24",{"date":511,"type":19},"2025-03-30",{"date":513,"type":19},"2026-07-20",{"name":515,"class":81},"Baylor College of Medicine",{"id":517,"slug":4,"hasResults":10,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":523,"enrollmentInfo":524,"targetDuration":4,"studyType":20,"phases":525,"briefSummary":526,"conditions":527,"keywords":531,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":171},"100477215","NCT05494060","XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma","XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma, a Randomized, Controlled, Multicenter Clinical Trial","EXPLORING","Inclusion Criteria:\n\n* Subjects aged ≥18 and ≤75 years old, male or female.\n* ECOG performance status score 0-1.\n* Histologically or cytologically confirmed GC or GEJ carcinoma, had been treated with Radical resection (D2, R0 or R1) of gastric cancer.\n* Pathological stage:III (8th AJCC TNM).\n* Estimated lifetime is greater than 6 months.\n* The main organs are functioning well, and the blood test results within 14 days before enrollment should meet the following requirements:\n\n  1. Routine blood test:\n\n     1. Hemoglobin (HB) ≥90 g\u002FL.\n     2. Neutrophil count (ANC) ≥1.5×109\u002FL.\n     3. Platelet count (PLT) ≥100×109\u002FL.\n  2. Biochemical test:\n\n     1. Total bilirubin≤1.5×ULN (upper limit of normal).\n     2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; if there is liver metastasis, ALT and AST ≤ 5×ULN.\n     3. Serum creatinine (Cr) ≤1.5 ULN or creatinine clearance ≥60mL\u002Fmin.\n* No obvious clinical symptoms of heart disease.\n* Must have disease-free status documented by complete physical examination and imaging studies with no evidence of recurrent, residual, or metastatic disease on standard imaging (chest, abdomen, and pelvis captured by CT chest and CT or MRI of abdomen and pelvis) per investigator assessment within 28 days prior to enrollment.\n* Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days of randomization and must be willing to use a highly effective method of birth control (Appendix 9) for the duration of the study, and ≥ 120 days after the last dose of penpulimab and 180 days after the last dose of chemotherapy.\n* Volunteer to participate in this study and sign an informed consent form.\n* Considering that NGS analysis may take up to 10 working days, patients could receive 1 cycle of XELOX chemotherapy after ctDNA sampling.\n\nExclusion Criteria:\n\n* Participation in other drug clinical trials within four weeks.\n* Multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction.\n* History of bleeding, any bleeding event with a severity grade of 3 or higher per CTCAE 5.0 within 4 weeks before screening.\n* Patients with known central nervous system metastasis or history of central nervous system metastasis prior to screening. For patients with clinically suspected central nervous system metastases, CT or MRI must be performed within 28 days before enrollment to rule out central nervous system metastases.\n* Patients with hypertension and uncontrolled by antihypertensive drugs alone (systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg); Patients with a history of unstable angina pectoris; Patients newly diagnosed as angina pectoris within 3 months before screening or myocardial infarction events within 6 months before screening; Arrhythmias (including QTcF ≥ 450 ms in men, ≥ 470 ms in women requiring long-term use of antiarrhythmic drugs and New York Heart Association Class ≥ II cardiac insufficiency;There are many factors that affect oral drug absorption (such as inability to swallow, nausea and vomiting, upper gastrointestinal obstruction, abnormal physiological function, malabsorption syndrome, etc.), which may affect anlotinib hydrochloride absorbers.\n* Long-term unhealed wound or unhealed fracture.\n* Imaging findings show that the tumor has invaded around important blood vessels or the patient's tumor has a very high possibility of invading important blood vessels during treatment and causing fatal massive hemorrhage as judged by the investigator.\n* Patients with abnormal coagulation function and bleeding tendency (the following criteria must be met within 14 days before randomization: INR is within normal range without anticoagulants or has no clinically significant abnormality); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; patients with prothrombin time international normalized ratio (INR) ≤ 1.5 are allowed to take low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (the daily dose does not exceed 100 mg) for preventive purposes.\n* Arteriovenous thrombotic events occurred within 6 months before screening, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except venous thrombosis caused by previous chemotherapy that has been judged by the investigator to have recovered) and pulmonary embolism.\n* Urine routine showed urine protein and 24 h urine protein was confirmed to be \\> 1.0g.\n* Previous use of immune targeted therapy drugs.\n* History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.\n* Patients with infectious pneumonia, pneumonitis, interstitial pneumonia and other conditions requiring corticosteroids.\n* History of severe chronic autoimmune diseases, such as systemic lupus erythematosus; history of inflammatory bowel disease such as ulcerative enteritis, Crohn's disease, irritable bowel syndrome and other chronic diarrheal diseases; history of sarcoidosis or tuberculosis; history of active hepatitis B, C and HIV infection; well-controlled non-serious immune diseases, such as dermatitis, arthritis, psoriasis, etc. Hepatitis B virus \\\u003C 1000 copies\u002Fml can be detected.\n* Patients with hypersensitivity to human or murine monoclonal antibodies.\n* Patients with a history of psychotropic substance abuse and unable to quit or with mental disorders.\n* Pleural or peritoneal effusion with clinical symptoms requiring clinical intervention.\n* Patients who do not follow the doctor's advice, do not take medicine as required, or have insufficient data that can affect the efficacy judgment or safety judgment.\n* Patients with concomitant diseases that, in the judgment of the investigator, seriously jeopardize the patient's safety or affect the patient's completion of the study.","75 Years",{"count":247,"type":19},[209],"This is an open label, randomized, phase Ⅱ, multi-cohort study to treat subjects with ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma. The patients will be randomized into two arms consist of Penpulimab + Anlotinib (3 weeks\u002Fcycle) + XELOX and XELOX at a ratio of 1:1. This study is conducted to assess safety and anti-tumor activity of the monoclonal antibody Penpulimab in combination with Anlotinib and standard chemotherapy as adjuvant treatment for ctDNA-positive Gastric, or Gastroesophageal Junction Carcinoma.",[528,126,305,529,125,530,26],"Carcinoma","Gastroesophageal-junction Cancer","Gastric Cancer",[532,533,534,535,536,537],"Penpulimab","Anlotinib","Capecitabine","Oxaliplatin","ctDNA","adjuvant therapy","2023-11-03",{"date":540,"type":31},"2023-11-07",{"date":542,"type":31},"2022-03-16",{"date":544,"type":19},"2027-02",{"name":546,"class":81},"The First Affiliated Hospital with Nanjing Medical University",{"id":548,"slug":4,"hasResults":10,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":552,"eligibilityCriteria":553,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":554,"enrollmentInfo":555,"targetDuration":4,"studyType":180,"phases":4,"briefSummary":557,"conditions":558,"keywords":570,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":584},"100435367","NCT04949282","Spanish Series of Patients Treated With the Radionuclide Lutetium177","SEPTRALU, Spanish Series of Patients Treated With the Radionuclide Lutetium177","SEPTRALU","Inclusion Criteria:\n\n* Written informed consent must be obtained prior to any data collection.\n* Patients must be diagnosed with unresectable or metastatic, progressive, somatostatin receptor positive tumour\n* Aged ≥18 years.\n\nExclusion Criteria:\n\n* None","100 Years",{"count":556,"type":19},5000,"This study aims to pool the clinical experience of Spanish centers treating patients with 177Lu-DOTATATE to evaluate the efficacy, tolerance, and safety of the drug in routine clinical practice and to learn about the profiles of patients and tumors treated and the results in each type of patient and tumor.",[559,122,53,560,561,562,563,564,565,26,123,124,566,125,567,128,568,569],"Neuroendocrine Tumors","Stomach Neoplasms","Neuroectodermal Tumors","Neoplasms, Germ Cell and Embryonal","Neoplasms by Histologic Type","Neoplasms","Neoplasms, Nerve Tissue","Endocrine Gland Neoplasms","Gastrointestinal Disease","Pancreatic Disease","Endocrine System Diseases",[571,572,573,574],"GEP-NET","Gastro-Entero-Pancreatic Neuroendocrine Tumour","Luthatera","Somatostatin receptor positive tumour","2022-12-22",{"date":577,"type":31},"2022-12-23",{"date":579,"type":31},"2021-05-10",{"date":581,"type":19},"2035-12-31",{"name":583,"class":81},"Sociedad Española de Medicina Nuclear e Imagen Molecular",20,{"id":586,"slug":4,"hasResults":10,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":590,"eligibilityCriteria":591,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":20,"phases":593,"briefSummary":594,"conditions":595,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":171},"100458627","NCT05252078","Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients","An Open, Single Arm, Multicenter, Exploratory Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients as Postoperative Adjuvant Therapy","ALTER-E005","Inclusion Criteria:\n\n* Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.\n* ≥ 18 years old.\n* ECOG performance status of 0-1\n* Patients with esophageal squamous cell carcinoma pathologically diagnosed as T1-2N1-3M0 or T3-4NanyM0.\n* Patients received radical (R0) resection of squamous cell carcinoma with no recurrence in imaging examination within 6-12 weeks after surgery, and need adjuvant therapy assessed by the researchers.\n* Laboratory tests must be met:\n* Neutrophils count =\u002F\\> 1.5 x 109\u002FL, platelets count =\u002F\\> 75 x 109\u002FL, Hb =\u002F\\> 90 g\u002FL, WBC =\u002F\\> 3 x 109\u002FL.\n* total bilirubin =\u002F\\\u003C 1.5 x ULN, ALT and AST =\u002F\\\u003C 2.5 x ULN.\n* Creatinine =\u002F\\\u003C 1.5 x ULN.\n* APTT, INR, PT =\u002F\\\u003C 1.5 x ULN.\n* TSH =\u002F\\\u003C ULN.\n* Myocardial enzymes in the normal range.\n* LVEF =\u002F\\> 50%.\n\nExclusion Criteria:\n\n* Patients received other antitumor adjuvant therapy after surgical resection.\n* Concurrent malignancy (except cured basal cell carcinoma of the skin).\n* Patients was diagnosed cervical esophageal carcinoma.\n* Patients who have received prior targeted therapy (anti-VEGF\u002FVEGFR) or immunity therapy (anti-PD-1\u002FPD-L1\u002FCTLA-4).\n* Patients who are allergic to other monoclonal antibodies.\n* Patients with a history of immunodeficiency (or active autoimmue disease), or other acquired congenital immunodeficiency diseases.\n* Immunosuppressant, systemic, or absorbable local hormone therapy (\\> 10mg\u002F day of prednisone or other equivalent hormone) is required for immunosuppression and continued within 2 weeks of initial administration.\n* Patients with multiple factors affecting oral administration.\n* Uncontrolled pleural effusion, pericardial effusion or ascites that requires repeated drainage.\n* With bleeding tendency. Patients with any bleeding or bleeding event CTC AE grade 3 in the 4 weeks prior to initial administration. The presence of digestive diseases or active bleeding of unresected tumors, or other conditions that the investigator determined which could lead to gastrointestinal bleeding or perforation.\n* Active or untreated CNS metastases as determined by CT or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments.\n* Patients with hypertension who could not be well controlled by antihypertensive drugs (systolic blood pressure \\> 160 mmHg, diastolic blood pressure \\> 100 mmHg).\n* Patients with myocardial infarction, myocardial ischemia, arrhythmias with poor control (including QTC interval male \\> 450 ms, female\\> 470 ms) and cardiac insufficiency of grade II according to NYHA standard.\n* Active or uncontrolled severe infection (≥ CTC AE Grade 2 infection).\n* HIV test positive.\n* Proteinuria =\u002F\\>2+ and confirmed 24-hour urinary protein quantification \\> 1.0 g.\n* Vaccination with prophylactic or attenuated vaccine within 4 weeks prior to initial administration.\n* According to the investigators' judgment, there are factors that endanger patient or prevent patients from completing the study.",{"count":48,"type":19},[209],"This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma (ESCC) Patients as Postoperative Adjuvant Therapy. In order to observe and evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules combined with TQB2450 Injection in treatment of patients with ESCC. The primary endpoint is disease free survival (DFS).",[596,597,598,26,126,123,125,124,563,599,600],"Esophageal Squamous Cell Carcinoma","Esophageal Neoplasms","Esophageal Diseases","Neoplasms, Squamous Cell","Carcinoma, Squamous Cell","2022-12-14",{"date":603,"type":31},"2022-12-16",{"date":605,"type":31},"2022-06-02",{"date":607,"type":19},"2026-11",{"name":609,"class":81},"Jiangxi Provincial Cancer Hospital",{"id":611,"slug":4,"hasResults":10,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":615,"eligibilityCriteria":616,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":617,"targetDuration":4,"studyType":20,"phases":619,"briefSummary":620,"conditions":621,"keywords":622,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":635,"locationsCount":171},"100390442","NCT04363983","Interaction Between Host, Microenvironment and Immunity on Gastrointestinal Neoplasms","Interaction Between Host, Microenvironment and Immunity on Gastrointestinal Neoplasms: A Retro-prospective Cohort Study","HoMING","Inclusion Criteria:\n\n* Carcinoma of colorectal, pancreatic, biliary tract or gastro-oesophageal, or neuroendocrine digestive tumors with cytologically or histologically proven, regardless of the stage;\n* Diagnosis between 1998 and 2030;\n* Be \\>\u002F= 18 years;\n* Have obtained signed informed consent (exemption for dead patients);\n* Affiliated to the French social security - welfare system in France (CMU included).\n\nExclusion Criteria:\n\n* Patient under tutoraship or curatorship;\n* Foreign patient under AME schema, a medical help from the state in France;\n* Pregnant or breastfeeding women (for prospective study);\n* Any clinical, psychological or social reason which should influence patient compliance with protocol, according to investigator;\n* Patient refusal.",{"count":618,"type":19},6300,[50],"The primary objective: association study of characteristics of tumoral microenvironment and immunity of digestive cancers with patients' overall survival (OS).",[26],[623,624,625,626,627],"gastrointestinal cancer","micro-environment","immunity","host","microbiota","2022-02-09",{"date":630,"type":31},"2022-02-23",{"date":632,"type":31},"2021-01-13",{"date":634,"type":19},"2031-01",{"name":636,"class":81},"Assistance Publique - Hôpitaux de Paris",""]