[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastroesophageal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastroesophageal-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,55,81,111,143,167,190,213,242,281,304,332,355,401,432,460,481,504],{"id":9,"slug":10,"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":24,"conditions":25,"keywords":38,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100569561","phase-2-a-phase-2-study-of-zanidatamab-in-patients-with-her2-expressing-tumors-100569561",false,"NCT06695845","A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors","A Phase 2, Open-label, Multicenter Study to Evaluate Efficacy and Safety of Zanidatamab for the Treatment of Participants With Previously Treated HER2-expressing Solid Tumors (DiscovHER PAN-206)","Inclusion Criteria:\n\n1. Is at least 18 years of age inclusive at the time of signing the informed consent\n2. Participants with locally advanced, unresectable, or metastatic solid tumors (except Biliary Tract Cancer (BTC), defined as gallbladder cancer or cholangiocarcinoma) who have progressed following at least 1 prior systemic treatment for metastatic or advanced disease and have no available treatment options that have confirmed benefit. Prior treatment with HER2-targeted therapy is not permitted (Cohort 1 only). For participants with breast cancer (Cohort 2) or GEA (Cohort 3), prior HER2-targeted therapy is permitted and prior therapy with trastuzumab deruxtecan (T-DXd) is required.\n3. HER2 overexpression (IHC 3+) must be determined by a sponsor designated central laboratory.\n4. All participants must have adequate tumor sample for submission to allow central HER2 testing.\n5. Presence of at least 1 measurable lesion as assessed by Independent Central Review (ICR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)\n6. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Has a life expectancy of at least 3 months, in the opinion of the investigator.\n8. Participants with history of treated and stable CNS metastases are eligible, provided the following criteria are met:\n\n   1. Participants also have measurable metastatic disease with HER2 overexpression (IHC 3+) outside the CNS.\n   2. Participants with treated CNS metastases that are no longer symptomatic may be included in the study if they recovered to \\\u003C Grade 1 (CTCAE Version 5.0 or higher) or baseline from the acute toxic effect associated with the treatment \\> 7 days prior to Cycle 1 Day 1.\n   3. Prior stereotactic radiosurgery or stereotactic radiotherapy should be completed at least 7 days (≥ 7 days) before the first dose of study intervention.\n9. Adequate organ functions.\n10. Females of childbearing potential must have a negative pregnancy test result.\n11. Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.\n\nExclusion Criteria:\n\n1. Has known or suspected leptomeningeal disease and\u002For untreated brain metastasis.\n2. Has uncontrolled or significant cardiovascular disease\n3. Has ongoing toxicity related to prior cancer therapy\n4. Has uncontrolled infection or requiring IV antibiotics, antivirals, or antifungals.\n5. Has known Human Immunodeficiency Virus (HIV) infection.\n6. Has active hepatitis B or C infection.\n7. Has an active SARS-CoV-2 infection.\n8. Has a history of life-threatening hypersensitivity to monoclonal antibody (mAbs) or to recombinant proteins or excipients in the drug formulation of zanidatamab.\n9. Has any serious underlying medical or psychiatric condition that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site.\n10. Has any issue or condition that, in the opinion of the investigator, would contraindicate the participant's participation in the study or confound the results of the study.\n11. Prior treatment with HER2-targeted therapy (Cohort 1 only).\n12. Has a history of trauma or major surgery\n13. Was treated with systemic antineoplastic therapy, including hormonal therapies for breast cancer, or any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.\n14. Received zanidatamab at any time prior to the current study.\n15. Colorectal Cancer (CRC) participants with known KRAS\u002FNRAS and BRAF mutations.\n16. Non-Small Cell Lung Cancer (NSCLC) participants with known ALK, EGFR mutations and ROS1 fusion.\n17. Female participants who are breastfeeding or pregnant, and female and male participants planning a pregnancy.\n18. Prior or concurrent invasive malignancy other than the disease under study, whose natural history or treatment has, in the opinion of the investigator or medical monitor, the potential to interfere with the safety or efficacy assessment of the investigational regimen.","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to evaluate the efficacy and safety of zanidatamab for the treatment of participants with previously treated solid tumors that have Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry (IHC) 3+ overexpression.",[26,27,28,29,30,31,32,33,34,35,36,37],"Breast Cancer","Gastric Cancer","Esophageal Cancer","Gastroesophageal Cancer","Colorectal Cancer","Endometrial Cancer","Non-small Cell Lung Cancer","Ovarian Cancer","Urothelial Carcinoma","Salivary Gland Cancer","Pancreatic Cancer","HER-2 Protein Overexpression",[39,40,41],"JZP598","ZW25","HER2 IHC 3+ Overexpression Solid Tumors","RECRUITING","2026-06-05",{"date":45,"type":46},"2026-06-09","ACTUAL",{"date":48,"type":46},"2025-01-14",{"date":50,"type":20},"2027-12-31",{"name":52,"class":53},"Jazz Pharmaceuticals","INDUSTRY",28,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":21,"phases":65,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100629952","phase-1-a-first-in-human-phase-iiia-study-to-evaluate-da-3501-in-patients-with-advanced-gastric-or-gastro-esophageal-junction-adenocarcinoma-and-pancreatic-ductal-adenocarcinoma-100629952","NCT07481357","A First-In-Human Phase I\u002FIIa Study to Evaluate DA 3501 in Patients With Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma and Pancreatic Ductal Adenocarcinoma","A First-In-Human Phase I\u002FIIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA 3501 in Patients With Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma and Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n1. Patients aged ≥ 19 years\n2. Histologically or cytologically documented advanced CLDN18.2+ GC\u002FGEJ adenocarcinoma or advanced CLDN18.2+ PDAC\n3. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)\n4. Life expectancy ≥12 weeks as judged by the Investigator\n\nExclusion Criteria:\n\n1. Cardiac abnormalities\n2. Gastrointestinal abnormalities\n3. Active and clinically significant bacterial, fungal, or viral infection, including known hepatitis B virus (HBV), known hepatitis C virus (HCV), known human immunodeficiency virus (HIV).\n4. Active systemic infection requiring IV antibiotics therapy.","19 Years",{"count":64,"type":20},51,[66],"PHASE1","The goal of this clinical trial is to determine the MTD or OBED of DA-3501 given in Q3W to determine a wRP2D in patients with advanced CLDN18.2 expressing (CLDN18.2+) GC\u002FGEJ and advanced CLDN18.2+ PDAC.\n\nParticipants will receive the assigned dose once every three weeks and, according to the study procedures, will undergo tumor assessments as well as safety assessments, PK evaluations, and ADA testing.",[69,70,71],"Gastric (Stomach) Cancer","GastroEsophageal Cancer","Pancreatic Ductal Adenocarcinoma (mPDAC)","2026-05-18",{"date":74,"type":46},"2026-05-20",{"date":72,"type":46},{"date":77,"type":20},"2029-02",{"name":79,"class":53},"Dong-A ST Co., Ltd.",3,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":108,"locationsCount":110},"100534466","phase-1-dose-escalation-and-dose-expansion-study-of-mdx2001-in-patients-with-advanced-solid-tumors-100534466","NCT06239194","Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors","A Phase 1\u002F2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Patients must be ≥ 18 years of age\n* Histologically or cytologically confirmed diagnosis of metastatic solid tumors\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* All patients should have at least 1 measurable disease per RECIST v1.1. An irradiated lesion can be considered measurable only if progression has been demonstrated on the irradiated lesion.\n* All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Adequate hematologic, hepatic and renal function\n* Capable of giving signed informed consent\n\nExclusion Criteria:\n\n* Any clinically significant cardiac disease\n* Unresolved toxicities from previous anticancer therapy\n* Prior solid organ or hematologic transplant\n* Known untreated, active, or uncontrolled brain metastases\n* Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infectiion requiring intravenous treatment.\n* Receipt of a live-virus vaccination within 28 days of planned treatment start\n* Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions.\n* Participation in a concurrent clinical study in the treatment period.\n* Known hypersensitivity to MDX2001 or any of its ingredients\n* Supplemental oxygen use for activities of daily living\n\nThe above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.",{"count":89,"type":20},285,[66,23],"This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.",[93,26,94,95,31,28,27,70,96,97,32,36,98,99,100,101],"Biliary Tract Cancer","Cervical Cancer","Colon Cancer","Head and Neck Cancer","Hepatocellular Cancer","Prostate Cancer","Rectal Cancer","Renal Cancer","Thyroid Cancer","2026-05-03",{"date":104,"type":46},"2026-05-06",{"date":106,"type":46},"2024-06-12",{"date":77,"type":20},{"name":109,"class":53},"ModeX Therapeutics, An OPKO Health Company",6,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":142},"100526705","the-effect-of-exercise-and-diet-on-quality-of-life-in-patients-with-incurable-cancer-of-esophagus-and-stomach-radices-100526705","NCT06138223","The Effect of exeRcise And Diet on Quality of Life in Patients With Incurable Cancer of Esophagus and Stomach (RADICES)","RADICES","Inclusion Criteria:\n\n* Incurable adenocarcinoma of the esophagus or stomach\n* Recurrence after treatment with curative intent or irresectable\u002Fmetastatic disease at primary diagnosis. Inclusion can take place regardless of the plan or the actual initiation of multi-line systemic treatment. (i.e. patients that have already started with anticancer therapy are eligible for inclusion too)\\*\n* Able and willing to perform the exercise and nutritional program and wear the activity tracker.\n* Able and willing to fill out the POCOP\u002FRADICES questionnaires.\n* Life expectancy \\> 12 weeks.\n* Age ≥ 18 years.\n\nExclusion Criteria:\n\n* Unstable bone metastases inducing skeletal fragility as determined by the treating clinician.\n* Untreated symptomatic known brain metastasis.\n* Serious active infection.\n* Too physically active (i.e. \\>210 minutes\u002Fweek of moderate-to-vigorous intentional exercise) or engaging in intense exercise training comparable to the RADICES exercise program.\n* Severe neurologic or cardiac impairment according to the American College of Sports Medicine criteria.\n* Uncontrolled severe respiratory insufficiency as determined by the treating clinician or if the patient is dependent on oxygen suppletion in rest or during exercise.\n* Uncontrolled severe pain.\n* Any other contraindications for exercise as determined by the treating physician.\n* Any circumstances that would impede adherence to study requirements or ability to give informed consent, as determined by the treating clinician.\n* Pregnancy.\n\n  * Note:\n\nAfter one year of recruitment we broadened our inclusion criteria from GAC patients receiving beyond first-line palliative treatment or best supportive care to any patient with recurrence\u002Fprogression of GAC after curative treatment or irresectable\u002Fmetastatic disease at diagnosis, regardless of timing or type of palliative treatment and number of lines received. This was done to increase generalizability and offer the intervention earlier in the palliative phase to enhance its benefits. We acknowledge this results in a more heterogeneous group, but we believe also a more representative group.\n\nThe inclusion criterium before broadening was:\n\nProgressive disease after first-line palliative systemic treatment OR within 6 months after completion of curative treatment (i.e. within six months after neoadjuvant chemoradiation, adjuvant nivolumab, or definitive chemoradiation for esophageal adenocarcinoma or within six months after adjuvant 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) for gastric\u002Fesophageal cancer or neoadjuvant FLOT if no adjuvant FLOT was given, or after progression during participation in the LyRICX study). Patients on capecitabine monotherapy who are eligible for oxaliplatin reintroduction can be included, too.",{"count":119,"type":20},196,[121],"NA","The survival of patients with incurable gastroesophageal cancer can extend over a year with anticancer therapy. However, the number of patients with deteriorating quality of life in this patient group steadily decreases over time during the treatment. Potentially reversible causes related to deterioration of quality of life are diminished muscle mass, physical capacity and nutritional status. Therefore, interventions that can target these in order to maintain or improve quality of life are urgently needed.\n\nHowever, it is yet unknown whether improvement of physical capacity and nutritional status improves quality of life in patients with incurable gastroesophageal adenocarcinoma after failure of first-line treatment. Since these patients are in a precarious situation, the benefits and harms of a combined exercise and nutritional intervention should be carefully evaluated.Therefore this study investigates the effect of a combined exercise and nutrition intervention compared to usual care on quality of life in incurable GAC patients after progression upon first-line treatment.\n\nA total of 196 patients with metastasized gastroesophageal cancer will be recruited and randomly allocated 1:1 to standard care or standard care plus a combined exercise and nutritional intervention.",[70,124],"Incurable Disease",[126,127,128,129,130,131,132],"gastroesophageal cancer","GAC","Palliative","exercise intervention","nutritional intervention","Quality of life","QOL",{"date":134,"type":46},"2026-05-07",{"date":136,"type":46},"2024-01-01",{"date":138,"type":20},"2028-09-30",{"name":140,"class":141},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",22,{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":21,"phases":152,"briefSummary":153,"conditions":154,"keywords":155,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":166},"100554321","support-through-remote-observation-and-nutrition-guidance-program-for-individuals-with-gastroesophageal-cancer-100554321","NCT06497569","Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer","Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer (STRONG-GEC)","Inclusion Criteria:\n\n* Participants must be 18 years of age or older\n* Participants must have locally advanced or metastatic gastroesophageal cancer (GEC)\n* Participants must plan to initiate chemotherapy and\u002For radiation therapy with a plan to have surgery or definitive treatment follow up at Moffitt\n* Participants must be able to speak and read Spanish and\u002For English\n* Participants must be able to provide informed consent\n\nExclusion Criteria:\n\n* Participants have a documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g. severe dementia)\n* Use of feeding tubes at the time of study enrollment",{"count":151,"type":20},80,[121],"The purpose of this study is to determine how the STRONG intervention compares with usual care for reducing malnutrition among gastroesophageal cancer patients.",[70],[156],"Nutrition Support","2026-03-31",{"date":159,"type":46},"2026-04-01",{"date":161,"type":46},"2024-07-26",{"date":163,"type":20},"2027-06",{"name":165,"class":141},"H. Lee Moffitt Cancer Center and Research Institute",2,{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":21,"phases":177,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":180,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":4},"100629651","phase-1-perioperative-zanidatamab-and-chemotherapy-for-her2-positive-gastroesophageal-cancer-100629651","NCT07477444","Perioperative Zanidatamab and Chemotherapy for HER2 Positive Gastroesophageal Cancer","Perioperative Zanidatamab Combined With Chemotherapy in Operable HER2 Positive Locally Advanced Operable Gastroesophageal Adenocarcinoma (GEA): A Phase 1b\u002F2a Single-Arm Trial","HER-OIC","Inclusion Criteria:\n\n* Voluntary written informed consent from the participant or their legally authorized representative\n* At least 18 years of age at the time of signing the consent form\n* Agreement to use highly effective birth control methods for both male and female patients\n* WHO-ECOG performance status of 0 or 1\n* Histologically proven HER2-positive gastroesophageal, esophageal, or gastric adenocarcinoma\n* Localized, resectable disease that is fit for perioperative treatment, including surgery\n* Adequate hepatic function\n* Adequate renal function with an estimated Glomerular Filtration Rate (GFR) \\> 50 mL\u002Fmin\n* Adequate hematologic function\n* Cardiac ejection fraction\n\nExclusion Criteria:\n\n* Prior neoadjuvant or definitive chemoradiation\n* Squamous cell cancer of the esophagus\n* Metastatic or unresectable gastroesophageal cancer\n* Active or relapsing autoimmune diseases, with exceptions for controlled Type 1 diabetes, hypothyroidism (hormone replacement only), controlled celiac disease, or certain skin diseases not requiring systemic treatment\n* Known hypersensitivity to zanidatamab, tislelizumab, or any of their excipients\n* Known Dihydropyrimidine Dehydrogenase (DPD) deficiency\n* Active infections requiring systemic treatment\n* History of significant cardiac disease\n* Previous malignancy within the last 5 years\n* Current participation in another interventional Trial involving an investigational medicinal product or device",{"count":176,"type":20},29,[66,23],"The HER-OIC clinical trial is a Phase 1b\u002F2a study investigating a new combination of treatments for patients with HER2-positive gastroesophageal cancer. Standard treatment for localized gastroesophageal cancer usually involves chemotherapy before and after surgery. This study aims to see if adding targeted therapy (zanidatamab) and immunotherapy (tislelizumab) to standard chemotherapy is safe and effectively eliminates the tumor. The goal is to improve the pathological complete response (pCR) rate, which is the percentage of patients who have no visible cancer cells remaining in the tissue removed during surgery.",[29],"NOT_YET_RECRUITING","2026-03-18",{"date":183,"type":46},"2026-03-20",{"date":185,"type":20},"2026-06-01",{"date":187,"type":20},"2033-06",{"name":189,"class":141},"Universitaire Ziekenhuizen KU Leuven",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":198,"phases":4,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":212},"100455038","trans-pacific-multicenter-collaborative-study-of-minimally-invasive-proximal-versus-total-gastrectomy-for-proximal-gastric-and-gastroesophageal-junction-cancers-100455038","NCT05205343","Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers","Inclusion:\n\n1. Able to speak and read English, Spanish, Japanese or Korean\n2. Participants with a biopsy-confirmed diagnosis of non-metastatic gastric or GEJ adenocarcinoma, who are scheduled to undergo MIPG or MITG for curative-intention\n3. Age ≥ 18\n\nExclusion:\n\n1. Participants with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract\n2. Participants with known narcotic dependence, with average daily dose \\> 5 mg oral morphine equivalent\n3. Participants deemed unable to comply with study and\u002For follow-up procedures, at investigators' discretion\n4. Participants who are pregnant (since are excluded from receiving standard-of-care MIPG or MITG)",{"count":197,"type":20},20,"OBSERVATIONAL","To compare the symptoms of patients who have a MIPG to the symptoms of patients who have a MITG.",[201,202,70],"Gastrostomy","Gastric","2026-02-02",{"date":205,"type":46},"2026-02-04",{"date":207,"type":46},"2022-05-11",{"date":209,"type":20},"2026-05-31",{"name":211,"class":141},"M.D. Anderson Cancer Center",4,{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":21,"phases":224,"briefSummary":225,"conditions":226,"keywords":227,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":166},"100552068","phase-2-synergistic-effects-of-pd-1-antibody-and-chemotherapytargeted-therapy-followed-by-surgery-centric-local-treatment-in-patients-with-limited-metastatic-gastric-cancer-100552068","NCT06468280","Synergistic Effects of PD-1 Antibody and Chemotherapy\u002FTargeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric Cancer","Synergistic Effects of PD-1 Antibody and Chemotherapy\u002FTargeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric or Gastroesophageal Adenocarcinoma (ROSETTE Trial): an Open-label, Single-center, Randomized Phase 2 Trial","ROSETTE","Inclusion Criteria:\n\n1. Men or women aged 18-79.\n2. Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (Siewert II or III only) with known PD-L1 expression status.\n3. Gastric cancer with proficient mismatch repair (pMMR) or microsatellite stability (MSS) as determined by immunohistochemistry or NCI-recommended microsatellite markers.\n4. Primary gastric cancer lesions are resectable, with limited distant metastases meeting the either of the following criteria: (1) condition (a) only; (2) any single condition from (b), with or without (a).\n\n   (a) Non-regional intra-abdominal lymph node metastasis: Include metastasis to the superior mesenteric artery, middle colic artery, and para-aortic\u002Fretroperitoneal nodes (according to AJCC 8th edition standards).\n\n   (b1) Localized peritoneal metastasis: P0CY1, P1a, or P1b, according to the Japanese Classification of Gastric Carcinoma (15th edition).\n\n   (b2) Liver metastasis: Up to 5 metastatic lesions. (b3) Lung metastasis: Up to 5 unilateral metastatic lesions. (b4) Ovarian metastasis: Unilateral or bilateral. (b5) Adrenal metastasis: Unilateral or bilateral. (b6) Single-region extra-abdominal lymph node metastasis: Such as cervical, supraclavicular, or mediastinal lymph nodes.\n\n   (b7) Bone metastasis limited to a single radiation field. (b8) Other limited metastases as determined by the research team.\n5. No previous anti-tumor treatments.\n6. ECOG score ≤2, no surgical contraindications.\n7. Life expectancy ≥ 3 months.\n8. Physical condition and organ function suitable for major abdominal surgery.\n9. Willingness and ability to comply with the study protocol.\n10. Fertile women with a negative urine or serum pregnancy test and agreement to use effective contraception during the study and for 180 days after the last dose. Non-sterilized men must also agree to use effective contraception.\n11. Signed informed consent with an understanding that patients can withdraw anytime.\n\nExclusion Criteria:\n\n1. Inability to tolerate oral chemotherapy.\n2. Primary gastric lesion confined to the mucosa or submucosa with isolated ovarian metastasis.\n3. Central nervous system metastasis and\u002For carcinomatous meningitis.\n4. Allergy to any components of the study medication.\n5. History of previous malignancies or concurrent other malignancies, with the exception of completely resected basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, and other tumors with no recurrence for at least 5 years.\n6. Uncontrolled pleural effusion, pericardial effusion, or ascites.\n7. Weight loss ≥20% within two months before enrollment.\n8. Upper gastrointestinal obstruction or physiological dysfunction.\n9. Previous cytotoxic chemotherapy, radiotherapy, immunotherapy, or curative surgery.\n10. Prior PD-1\u002FPD-L1\u002FPD-L2 or other T-cell-targeting therapy.\n11. Systemic steroid or immunosuppressant use within 14 days before enrollment.\n12. Live vaccine within four weeks prior to enrollment.\n13. Uncontrolled systemic disease.\n14. Active or past autoimmune diseases that may recur.\n15. Severe chronic infections or active infections requiring systemic antibacterial, antifungal, or antiviral treatment.\n16. History of lung disease.\n17. Pregnancy, lactation, or planning for pregnancy.\n18. HBsAg-positive with HBV DNA ≥500 IU\u002FmL.\n19. Positive HIV antibody.\n20. Conditions that may impact study compliance or participation.","79 Years",{"count":223,"type":20},84,[23],"ROSETTE trial is an open-label, randomized phase II study designed to investigate treatment strategies for patients with limited metastatic gastric or gastroesophageal adenocarcinoma. Eligible patients are randomized to receive either systemic treatment followed by surgeon-led local treatment, or systemic treatment alone. Systemic treatment combines immunotherapy with chemotherapy, with or without targeted therapy, while the surgeon-led local treatment utilizes a surgery-centric, multi-modality approach involving resection of both primary and metastatic tumors where feasible. For unresected or unresectable metastatic lesions, alternative local therapies are provided. The primary endpoint is the 1-year event-free survival (EFS) rate. Secondary endpoints include objective response rate (ORR), disease control rate (DCR), extended EFS, overall survival (OS), pathologic complete response rate (pCR), major pathologic response rate (MPR), and R0 resection rate.",[27,70],[228,229,230,231,232],"Limited metastasis","Surgery","Local treatment","Gastric cancer","Perioperative treatment","2026-01-18",{"date":235,"type":46},"2026-01-21",{"date":237,"type":46},"2024-11-08",{"date":239,"type":20},"2028-12",{"name":241,"class":141},"Shanghai Zhongshan Hospital",{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":198,"phases":4,"briefSummary":252,"conditions":253,"keywords":259,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":280},"100617394","sample-collection-for-ongoing-research-and-product-evaluation-study-100617394","NCT07318051","Sample Collection for Ongoing Research and Product Evaluation Study","Sample Collection for Ongoing Research and Product Evaluation (SCORE) Study","SCORE","Inclusion Criteria:\n\n1. 18 years of age or older.\n2. Any patient that has an untreated primary solid malignancy within the following cohorts:\n\n   1. Breast cancer\n   2. Lung cancer\n   3. Muscle invasive bladder cancer\n   4. Rectal cancer\n   5. Pancreatic cancer\n   6. Ovarian cancer\n   7. Gastroesophageal cancer\n   8. Prostate cancer\n   9. Melanoma\n   10. Hepatic\u002Fliver cancer\n   11. Uterine\u002Fendometrial cancer\n   12. Head and neck Cancer\n3. The participant has a suspected primary malignancy of pancreatic, endometrial, bladder, or ovarian cancer based on imaging.\n4. Eastern Cooperative Oncology Group performance status ≤ 2.\n5. Able to tolerate venipuncture for research blood draw(s).\n6. Consent to provide residual tumor tissue for research.\n7. Willing and able to comply with the study requirements.\n8. Signed informed consent(s) must be obtained prior to participation in the study.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding.\n2. Prior history and treatment for any cancer within the past year or has another active cancer, with the exception of participants who have undergone surgical removal of skin squamous cell or basal cell cancers.\n3. Has initiated postoperative systemic treatment.\n4. At time of enrollment, has undergone or plans to undergo any ctDNA testing to assess molecular residual disease, with the exception of comprehensive genomic profiling for therapeutic selection.\n5. History of bone marrow or organ transplant.\n6. Serious medical conditions that may adversely affect ability to participate in the study.",{"count":251,"type":20},9600,"The SCORE study is a prospective, multi-site clinical trial designed to collect blood and tissue samples, along with relevant clinical data, from participants diagnosed with various solid tumors. The collected specimens and information will be used to evaluate the clinical performance of Natera's molecular residual disease (MRD) testing across multiple cancer types. The study aims to assess the ability of Natera's assays to detect circulating tumor DNA (ctDNA) as a marker for disease recurrence and treatment response.",[26,254,255,99,36,33,29,98,256,96,257,258],"Lung Cancer","Muscle Invasive Bladder Cancer","Melanoma","Uterine Cancer","Liver Cancer",[260,261,262,263,264,265,266,267,256,268,269,270],"Breast cancer","Lung cancer","Muscle invasive bladder cancer","Rectal cancer","Pancreatic cancer","Ovarian cancer","Gastroesophageal cancer","Prostate cancer","Head and Neck cancer","Uterine cancer","Liver cancer","2026-01-13",{"date":273,"type":46},"2026-01-15",{"date":275,"type":46},"2025-07-21",{"date":277,"type":20},"2035-01",{"name":279,"class":53},"Natera, Inc.",1,{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":21,"phases":291,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":166},"100367821","phase-2-novel-sequenced-immunotherapy-with-anti-angiogenesis-and-chemotherapy-in-advanced-gastroesophageal-adenocarcinoma-100367821","NCT04069273","Novel SEQUEnced Immunotherapy With Anti-angiogenesis and Chemotherapy in Advanced gastroesophageaL Adenocarcinoma","Phase 2 Study of Novel SEQUEnced Immunotherapy (Pembrolizumab) With Anti-angiogenesis and Chemotherapy in Advanced Gastric and gastroesophageaL Junction (GEJ) Adenocarcinoma","SEQUEL","Inclusion Criteria:\n\n* Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n* Age ≥ 18 years at the time of consent.\n* ECOG Performance Status (PS) of 0-1within 28 days prior to registration. NOTE: Within 0-3 days prior to the anticipated C1D1, ECOG PS must be 0-1.\n* Tumor tissue must be obtained from a biopsy performed either (a) prior to registration or (b) prior to C1D1, as described below.\n\n  * Prior to registration: if a biopsy was performed prior to registration and no interval systemic anti-cancer treatment was administered between the biopsy collection and C1D1, part of that tissue is required for correlative analysis, and must be identified during screening and shipped after registration. In this situation, tissue from a new biopsy is not required.\n  * Prior to C1D1: For all other subjects, a new biopsy prior to C1D1 is required (research biopsy per parallel biopsy protocol entitled: \"Exploration of tumor biology in patients with metastatic esophageal and gastric cancer\", \\[biorepository protocol for prospective tissue collection\\]) to obtain tissue.\n  * NOTE: If tissue cannot be obtained by either of the above approaches (e.g., clinically contraindicated), the subject is not eligible for trial participation.\n* Willingness to provide tissue and blood samples for correlative research purposes and presence of a malignant lesion that is amenable to repeat biopsy while on study protocol (e.g., primary tumor that can be accessed by EGD).\n\n  --NOTE: Enrollment in parallel biopsy protocol, if open for enrollment, is required. Parallel biopsy protocol entitled: \"Exploration of tumor biology in patients with metastatic esophageal and gastric cancer (biorepository protocol for prospective tissue collection)\".\n* PD-L1 results are required, if available. If PD-L1 testing has not been done, it should be ordered as standard of care prior to C1D1. PD-L1 testing must be performed by a CLIA certified lab using the Dako 22C3 antibody.\n* Histologically or cytologically proven adenocarcinoma of the stomach or GEJ.\n* Metastatic, recurrent, or locally advanced unresectable disease.\n* Candidate for pembrolizumab, ramucirumab, and paclitaxel (or nab-paclitaxel)\n* Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 28 days prior to registration. NOTE: Labs must also be obtained within 10 days prior to C1D1 treatment.\n\n  * Absolute Neutrophil Count (ANC) ≥ 1,100\u002Fmm3\n  * Hemoglobin (Hgb) ≥ 8.5 g\u002FdL without transfusion or EPO dependency\n  * Platelets ≥ 100,000 \u002F mcL\n  * Creatinine OR Calculated creatinine clearance (institutional standard for calculation of CrCl may be used) ≤ 1.5 x upper limit of normal (ULN) OR ≥ 60 mL\u002Fmin for subject with creatinine levels \\> 1.5 x institutional ULN\n  * Total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN OR total bilirubin ≤ 2 x ULN if liver metastases are present (patients with Gilbert's syndrome are allowed)\n  * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 X ULN OR ≤ 5 x ULN for subjects with liver metastases\n  * Albumin \\> 3.0 g\u002FdL\n* Females of childbearing potential must have a negative pregnancy test within 72 hours prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months\n* Females of childbearing potential and males must be willing to abstain from heterosexual intercourse or to use 2 forms of effective methods of contraception from the time of informed consent (females)\u002Fprior to C1D1 (males) until 120 days after treatment discontinuation.\n* Willingness to return to the enrolling institution for follow up\n\nExclusion Criteria for all cohorts:\n\n* Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease (relevant for ramucirumab).\n* Any of the following cardiac criteria:\n\n  * Clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., clinically important forms of complete left bundle branch block, third degree heart block, second degree heart block, mean resting corrected QT interval (QTc using Fridericia's formula) \\> 470 msec, PR interval \\>250msec. NOTE: Investigators are encouraged to discuss potentially clinically important arrythmias with a cardiologist and consider implementing more frequent monitoring if appropriate (e.g., more frequent ECGs).\n  * Symptomatic heart failure, uncontrolled hypokalemia despite repletion, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives. NOTE: Factors that increase risk of QTc prolongation or risk of arrhythmia, such as concomitant medications, may require increased monitoring during Combination Therapy (See Section 7).\n  * The patient has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to first dose of protocol therapy.\n  * The patient has uncontrolled or poorly-controlled hypertension (\\>160 mmHg systolic or \\> 100 mmHg diastolic for \\>4 weeks) despite standard medical management.\n* The patient has experienced any Grade 3-4 GI bleeding within 3 months prior to first dose of protocol therapy (relevant for ramucirumab).\n* Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) with a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis (relevant for ramucirumab).\n* Hemoptysis (defined as bright red blood or ≥ 1\u002F2 teaspoon) within 2 months prior to first dose of protocol therapy or with radiographic evidence of intratumor cavitation or has radiologically documented evidence of major blood vessel invasion or encasement by cancer (relevant for ramucirumab) that in the opinion of the investigator poses unacceptably high risk as standard clinical practice when combined with ramucirumab.\n* The patient has a prior history of GI perforation\u002Ffistula (within 6 months of first dose of protocol therapy) that in the opinion of the investigator poses unacceptably high risk as standard clinical practice when combined with ramucirumab.\n* The patient has a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to first dose of protocol therapy that in the opinion of the investigator poses unacceptably high risk as standard clinical practice when combined with ramucirumab.\n* The patient has undergone major surgery within 28 days prior to first dose of protocol therapy prior to the first dose of protocol therapy. The patient has elective or planned major surgery to be performed during the course of the clinical trial (relevant for ramucirumab).\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.\n* Has active autoimmune disease that has required systemic treatment in the past 6 months (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs) that in the opinion of the investigator poses unacceptably high risk as standard clinical practice when combined with pembrolizumab. Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. NOTE: Inhaled steroids or steroid injections for joint disease are allowed.\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.\n* Prior therapy combining anti-angiogenesis agent with cytotoxic agent(s). NOTE: Prior single-agent anti-angiogenesis therapy (eg, ramucirumab monotherapy) is allowed.\n* Patients known to be HIV positive.\n* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n* Prior severe allergic reactions to a monoclonal antibody or hypersensitivity to pembrolizumab or any of its excipients.\n* Has had a prior anti-cancer monoclonal antibody (mAb), excluding anti-PD-1\u002F-L1 therapy, within 3 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 3 weeks earlier.\n* Other active malignancy which requires current treatment and which in the opinion of the site investigator is likely to interfere with evaluation of disease assessment. NOTE: Continuation of hormonal therapies is allowed.\n* Patients with known active central nervous system (CNS) metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.\n* Uncontrolled intercurrent illness which in the opinion of the investigator poses unacceptably high risk when combined with study treatment, including but not limited to the following:\n\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Severely impaired lung function\n  * Known history of active TB (Bacillus Tuberculosis)\n  * Uncontrolled diabetes as defined by fasting serum glucose \\>1.5 x ULN (NOTE: Optimal glycemic control should be achieved before starting trial therapy.)\n  * Significant underlying liver disease such as severe cirrhosis or hepatic impairment\n  * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Has an active infection requiring systemic therapy prior to therapy initiation and that in the opinion of the investigator poses unacceptably high risk as standard clinical practice when starting study treatment.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.\n* Has known history of or any evidence of active, non-infectious pneumonitis that in the opinion of the investigator poses unacceptably high risk as standard of clinical practice when starting study treatment.\n* Currently uncontrolled hyper\u002Fhypothyroidism or hyper\u002Fhypocortism if in the opinion of the investigator they pose unacceptably high risk when combined with study treatment.\n* Received live vaccine or live attenuated vaccine within 30 days prior to registration. NOTE: Administration of killed vaccines is allowed.\n* Prior toxicity from immune checkpoint inhibitors (eg. pancreatitis, enteritis) that was symptomatic or required medical intervention ≤ 6 months prior to registration, which in the opinion of the investigator poses unacceptably high risk as standard clinical practice when starting study treatment.\n* Pre-existing motor or sensory neurotoxicity grade 3 or higher.\n* Prior solid organ or allogeneic transplant.\n\nEligibility specific to Cohort 1:\n\n* Inclusion: Measurable disease per RECIST v1.1\n* Exclusion: Disease progression according to RECIST v1.1 or irRECIST, or treatment intolerance, during prior therapy with an anti-PD-1, anti-PD-L1, or anti- PD-L2 agent. NOTE: Stable or responsive disease on anti-PD-1\u002FL1-L2 therapy (without concurrent cytotoxic therapy) is allowed.\n* Exclusion: Weight loss ≥ 5% during prior anti-PD-1, anti-PD-L1, or anti- PD-L2-containing therapy (from time of initiation of such therapy to most recent dose).\n\nEligibility specific to Cohort 2:\n\n* Inclusion: Measurable or evaluable disease per RECIST v1.1.\n* Inclusion: Received anti-PD-1 therapy with or without concurrent cytotoxic chemotherapy as preceding therapy.\n* Inclusion: PD-L1 combined positive score (CPS) ≥ 1 or tumor proportion score (TPS) ≥ 1 at any time before registration. NOTE: PD-L1 expression status in tissue samples collected at baseline before receiving any prior systemic anticancer therapy are of highest interest.",{"count":290,"type":20},58,[23],"Cohort 1 \\[CLOSED\\] Study treatment involves two segments: (1) Induction Immunotherapy segment with pembrolizumab monotherapy every 3 weeks until irRECIST PD and (2) Combination Therapy segment. Nab-paclitaxel may be utilized in place of paclitaxel at investigator's discretion for subjects with paclitaxel reactions.\n\nCohort 2 Patients are randomized to Arm A or B. Treatment in both arms includes pembrolizumab + RAM + paclitaxel.",[27,70,294],"Adenocarcinoma","2025-07-29",{"date":297,"type":46},"2025-07-31",{"date":299,"type":46},"2020-12-01",{"date":301,"type":20},"2026-12-10",{"name":303,"class":141},"Harry H Yoon",{"id":305,"slug":306,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":21,"phases":312,"briefSummary":313,"conditions":314,"keywords":316,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":280},"100585785","phase-2-pulso-trial-pulsed-low-dose-rate-pldr-radiation-chemoradiation-crt-vs-standard-crt-for-esophageal-cancer-100585785","NCT06906887","PULSO Trial: Pulsed Low-Dose-Rate (PLDR) Radiation Chemoradiation (CRT) vs. Standard CRT for Esophageal Cancer","Inclusion Criteria:\n\nA potential study subject who meets all of the following inclusion criteria is eligible to participate in the study.\n\n1. Age ≥ 18 years.\n2. Stage II-IVb adenocarcinoma of the esophagus (if IVb, oligometastatic only, felt to be eligible for definitive dose CRT treatment by treating physician).\n3. Currently receiving or have received induction chemotherapy and planned for definitive dose chemoradiation (+\u002F- esophagectomy).\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n5. Adequate hematologic function within 30 days prior to registration defined as follows:\n\n   1. Absolute Neutrophil Count ≥ 1,500\u002Fmcg\n   2. Hemoglobin ≥ 8 gm\u002FdL\n   3. Platelets ≥ 100,000\u002FmcL.\n6. Adequate renal function within 30 days prior to registration, defined as a creatinine clearance of ≥ 50 ml\u002Fmin as calculated by the Cockcroft-Gault equation.\n7. Adequate hepatic function within 30 days prior to registration, defined as total bilirubin ≤ 1.5 x ULN\n\n   a. Note: patients with known Gilbert Syndrome can have a total bilirubin \\\u003C 2.5 x upper limit of normal (ULN).\n8. Female patients \\\u003C65 years of age and of childbearing potential must have a negative serum\u002Furine pregnancy test within 14 days prior to study entry. A female not of childbearing potential is one who has undergone a hysterectomy, bilateral oophorectomy, tubal ligation, or who has had no menses for 12 consecutive months.\n9. Patients of reproductive potential must agree to use effective contraception for the duration of study treatment. Effective contraception includes oral contraceptives, implantable hormonal contraception, double-barrier method, or intrauterine device.\n10. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n11. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\nA potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.\n\n1. Age \\\u003C 18 years.\n2. Extensive distant metastatic cancer, defined as \\>5 metastases.\n3. Recurrent esophageal cancer.\n\n   a. Note: prior or concurrent malignancies are allowed if they do not impact the study's primary endpoint (i.e., treatment-associated toxicity).\n4. Prior non-approved chemotherapy for the treatment of cancer.\n5. Prior radiotherapy to the region of the study cancer that would result in an overlap of radiation therapy fields.\n6. Women must not be pregnant or breast-feeding.",{"count":311,"type":20},50,[23],"This is a prospective, randomized, open-label, two-arm phase 2 trial that will evaluate whether the use of Pulsed Low-Dose-Rate radiation technique, as compared to standard radiation, is associated with reduced rates of clinically significant esophagitis during and following chemoradiation.",[28,315,70],"Oesophageal Cancer",[317,318,319,320,28,315,70,321,322],"Pulsed Low-Dose-Rate Radiation","Chemoradiation","esophagitis","Esophagectomy","Pulsed reduced dose rate radiation","Pulsed radiation","2025-06-25",{"date":325,"type":46},"2025-06-29",{"date":327,"type":46},"2025-06-17",{"date":329,"type":20},"2032-06-01",{"name":331,"class":141},"Medical College of Wisconsin",{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":21,"phases":342,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":180,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":4},"100591256","phase-1-peri-operative-treatment-of-resectable-gastroesophageal-cancer-using-bemarituzumab-bema-plus-perioperative-treatment-100591256","NCT06978062","Peri-operative Treatment of Resectable Gastroesophageal Cancer Using Bemarituzumab (BEMA) Plus Perioperative Treatment","An Open-label, Multi-centre, Phase 1b Safety and Feasibility Study for the Peri-operative Treatment of Resectable Gastroesophageal Cancer Using Bemarituzumab (BEMA) Plus Perioperative Treatment (NeoBEMA)","NeoBEMA","Inclusion Criteria:\n\n* Signed screening informed consent\n* Age ≥ 18 years\n* Availability of a diagnostic tumour sample for central evaluation (FFPE block or minimum 10 slides).\n* Histologically proven, previously untreated, locally advanced, resectable gastric\u002FGEJ adenocarcinoma cT2-cT4, N0, M0 or cTany, N+, M0. Note: if the results of the staging laparoscopy are pending at this stage it is acceptable to include the patients in this step, in the interest of patient time-to-treatment.\n* Planned peri-operative treatment with FLOT chemotherapy and surgically assessed feasible R0 resection\n* Centrally confirmed FGFR2b overexpression as defined by ≥10% tumour cells with 2+\u002F3+ FGFR2b staining by immunohistochemistry (IHC)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Previously untreated, locally advanced, histologically confirmed, resectable gastric\u002FGEJ adenocarcinoma cT2-cT4, N0, M0 or cTany, N+, M0 by radiological and surgical staging\n* Adequate hematologic and organ function\n\nExclusion Criteria:\n\n* Prior anticancer treatment for the disease under investigation\n* History or evidence of systemic disease or ophthalmological disorders requiring chronic use of ophthalmologic corticosteroids\n* Evidence of any ongoing ophthalmologic abnormalities or symptoms that are recent (within 4weeks) or actively progressing\n* Unwillingness to avoid the use of contact lenses during study treatment and follow-up period of at least 100 days after end of treatment.\n* Evidence of, or recent (within 6 months) history of, corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer. Recent (within 6 months) corneal surgery or ophthalmologic laser treatment\n* History of solid organ transplantation\n* History of interstitial lung disease\n* Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study\n* Patients on immunosuppressive therapy or having immune system disorders, including auto-immune diseases. Concurrent steroid use of not more than an equivalent of 10 mg\u002Fday prednisolone is allowed. Inhaled, intranasal, intraocular, and\u002For joint injections of corticosteroids are allowed.",{"count":341,"type":20},27,[66],"This is an open-label,multi-centre, phase 1b safety and feasibility study aiming to assess the safey and feasibility of bemarituzumab plus chemiotherapy (FLOT) for the peri-operative treatment of resectable gastroesophageal cancer. Following this neo-adjuvant part, patients should undergo surgery. Following surgery, patients will receive FLOT chemotherapy in combination with bemarituzumab. Imaging will be performed every 3 months for the first 2 years and thereafter every 6 months as per standard of care.",[70],"2025-06-02",{"date":347,"type":46},"2025-06-05",{"date":349,"type":20},"2026-02-20",{"date":351,"type":20},"2029-09-28",{"name":353,"class":354},"European Organisation for Research and Treatment of Cancer - EORTC","NETWORK",{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":363,"enrollmentInfo":364,"targetDuration":4,"studyType":21,"phases":366,"briefSummary":368,"conditions":369,"keywords":384,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":166},"100518299","phase-2-total-neoadjuvant-flot-chemotherapy-in-locally-advanced-gastric-and-gastroesophageal-junction-cancer-100518299","NCT06028737","Total Neoadjuvant FLOT Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer","Total Neoadjuvant Chemotherapy With 5-fluoruracil, Leucovorin, Oxaliplatin, and Docetaxel in Locally Advanced Gastric and Gastroesophageal Junction Cancer (OCTASUR): Randomized, Multi-center, Open-label Trial, Phase 2\u002F3","OCTASUR","Inclusion Criteria:\n\n* Tumor spread according to TNM: ≥cT3 and\u002For ≥cN0 and M0 (except of invasion of the common hepatic artery, celiac trunk, proximal part of the splenic artery, aorta, head of the pancreas);\n* Performance status by Eastern Cooperative Oncology Group (ECOG): 0 - 1;\n* Histologically confirmed gastric adenocarcinoma or gastroesophageal junction (Siewert type 2\u002F3) adenocarcinoma.\n* Differentiation grade: G0 - G4;\n* Tumor localization: cardio-esophageal junction (Siewert 2, 3), cardiac part of the stomach, body of the stomach, antral part of the stomach, pyloric part of the stomach;\n* Tumor extension: esophagus, diaphragm, liver, body and tail of the pancreas, anterior abdominal wall, small and large intestine, distal part of the splenic artery, spleen;\n* Patient agrees to participate in this biomedical study.\n\nExclusion Criteria:\n\n* Presence of another oncological disease at a different site if less than 5 years have passed since radical treatment.\n* Comorbidities or patient conditions that preclude the administration of chemotherapy.","80 Years",{"count":365,"type":20},150,[23,367],"PHASE3","The main goal of this study is to investigate the proportion of participants with locally advanced gastric and gastroesophageal adenocarcinoma without previous treatment during the last 5 years who can tolerate all planned cycles of chemotherapy and radical surgical treatment who will be prospectively randomized into two groups to undergo one of two chemotherapy regimens, followed by surgery:\n\n1. 8 cycles of Total Neoadjuvant ChemoTherapy (TNT) with 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin, and Docetaxel (FLOT) followed by surgery.\n2. 4 cycles of Neoadjuvant FLOT chemotherapy scheme preoperatively and 4 adjuvant FLOT cycles postoperatively.",[27,370,70,371,372,373,374,375,376,377,378,379,380,381,382,383],"Stomach Cancer","Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","Advanced Gastric Adenocarcinoma","Gastric Neoplasm","Stomach Neoplasm","Gastrointestinal Cancer","Advanced Gastroesophageal Junction Adenocarcinoma","Advanced Gastric Carcinoma","Chemotherapy","Gastrectomy","Gastrectomy for Gastric Cancer","Gastric Resection","Gastric (Cardia, Body) Cancer",[385,386,387,380,388,389,390,391,231],"Total neoadjuvant chemotherapy","FLOT","Fluoruracil","Perioperative chemotherapy","Docetaxel","Leucovorin","Gastric resection","2025-04-30",{"date":394,"type":46},"2025-05-06",{"date":396,"type":46},"2025-03-25",{"date":398,"type":20},"2032-12-31",{"name":400,"class":141},"Ukrainian Society of Clinical Oncology",{"id":402,"slug":403,"hasResults":11,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":16,"minAge":409,"maxAge":410,"enrollmentInfo":411,"targetDuration":4,"studyType":21,"phases":413,"briefSummary":414,"conditions":415,"keywords":418,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":280},"100548546","phase-2-a-value-driven-study-on-reducing-immune-checkpoint-inhibitor-dosing-frequency-in-advanced-cancers-100548546","NCT06422403","A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers","A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers: Phase 2 Randomized Trial (VALUE-CHECK)","VALUE-CHECK","Inclusion Criteria:\n\n1. Provision of informed consent prior to any study-specific procedure\n2. Patients with one of the following:\n\n   * Cohort A: Previously untreated locally advanced\u002Fmetastatic HER2 -ve gastric\u002Fgastroesophageal junction\u002Fesophageal (PDL1 CPS ≥5% adenocarcinomas not amenable to curative surgery or radiotherapy who are above to begin platinum double and nivolumab.\n   * Cohort B: Previously untreated locally advanced\u002Fmetastatic Child's A hepatocellular carcinoma not amenable to curative surgery or radiotherapy who are above to begin atezolizumab and bevacizumab.\n   * Cohort C: Previously untreated locally advanced\u002Fmetastatic lung adenocarcinoma (PDL1 TPS≥50%, EGFR\u002FALK wildtype) not amenable to curative surgery or radiotherapy who are above to begin pembrolizumab monotherapy\n3. Measurable disease per RECIST 1.1 criteria\n4. ECOG Performance status is 0-2\n5. Normal organ and bone marrow function measured within 28 days before the study as defined below:\n\n   * Haemoglobin ≥ 8.0 g\u002FdL and no blood transfusions in the 28 days prior to entry\n   * Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL\n   * No features suggestive of MDS\u002FAML on peripheral blood smear\n   * White blood cells (WBC) \\> 3x10\\^9\u002FL\n   * Platelet count ≥ 100 x 10\\^9\u002FL\n   * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\n   * AST (SGOT)\u002FALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN\n   * Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN)\n6. A life expectancy ≥ 12 weeks in all patients.\n7. Females in childbearing age should be using adequate contraceptive measures, should not be breastfeeding and their pregnancy test prior to the start of treatment must be negative. Evidence of non-child-bearing potential is fulfilled by one of the following criteria at screening:\n8. The post-menopausal period defined as age ≥50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments\n9. Women \\\u003C50 years old they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range.\n10. Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not a tubal ligatio\n11. Male patients should be willing to use barrier contraception\n12. The patient is willing to comply with the protocol during the study including undergoing treatment and scheduled visits and examinations including follow up.\n13. At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is considered suitable for accurate repeated measurements\n\nExclusion Criteria:\n\n1. Patients who have previously received immune checkpoint inhibitors or investigational monoclonal antibody therapy.\n2. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years\n3. Unstable spinal cord compression\u002Fbrain metastases unless asymptomatic and not requiring steroids for at least 2 weeks prior to the start of study treatment. For patients with brain metastases, gamma knife or stereotactic brain surgery is allowed prior to study treatment.\n4. Major surgery within 4 weeks of starting study treatment and patients must have recovered from any effects of any major surgery. Minor surgery is allowed.\n5. Severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which based on investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or having active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.\n6. Autoimmune disorders\n7. Males and females of reproductive potential who are not using an effective method of contraception and females who are pregnant or breastfeeding or have a positive serum pregnancy test prior to study entry\n8. Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements\n9. Previous allogeneic bone marrow transplant.","21 Years","99 Years",{"count":412,"type":20},360,[23],"This study is a prospective, open label, multi-centre phase 2 trial which assesses the efficacy and safety of standard dosing compared to extended dosing interval of nivolumab, atezolizumab or pembrolizumab in advanced\u002Funresectable gastric\u002Fgastroesophageal junction\u002Foesphageal adenocarcinomas with PDL1 CPS ≥5%, hepatocellular carcinoma andnon-small cell lung cancer with PDL1 TPS≥50% with no prior treatment. The investigators hypothesize that nivolumab, pembrolizumab and atezolizumab can be used efficiently at extended dosing intervals, compared to their approved labels with comparable clinical outcome.",[416,371,70,315,32,417],"Carcinoma, Hepatocellular","Head and Neck Squamous Cell Carcinoma",[419,420,421,422],"Nivolumab","Atezolizumab","Pembrolizumab","Extended dosing interval","2025-01-08",{"date":425,"type":46},"2025-01-10",{"date":427,"type":46},"2024-11-25",{"date":429,"type":20},"2029-12-31",{"name":431,"class":141},"National University Hospital, Singapore",{"id":433,"slug":434,"hasResults":11,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":440,"enrollmentInfo":441,"targetDuration":4,"studyType":21,"phases":443,"briefSummary":444,"conditions":445,"keywords":447,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":280},"100472427","anti-migration-system-for-anti-reflux-oeso-gastric-stent-antimig-100472427","NCT05431738","Anti-Migration System for Anti-reflux Oeso-gastric Stent (ANTIMIG)","Esophageal Stent With or Without Anti-migration Device for Tumors of the Gastroesophageal Junction: Multicenter Randomized Controlled Study. ANTIMIG Study","ANTIMIG","Inclusion Criteria:\n\n1. Patient of both sexes aged 18 or over.\n2. Patient admitted to one of the investigation centers for dysphagia due to tumoral stenosis of the gastroesophageal junction, locally advanced or metastatic.\n3. Patient ASA 1, ASA 2, ASA 3\n4. Absence of participation in another clinical study\n5. Signed Informed Consent\n6. Patients benefiting from the social security system.\n\nExclusion Criteria:\n\n1. Patient referred for stenosis by extrinsic compression by an extra digestive mass\n2. Patients with contraindications relating to the procedures essential for the introduction of a stent\n3. Mediastinal radiotherapy or esophageal surgery history\n4. Patient under 18 or over 90\n5. Patient ASA 4, ASA 5\n6. Pregnant Woman\n7. Patient unable to give personal consent\n8. Absence of signed informed consent","91 Years",{"count":442,"type":20},180,[121],"The aim of this prospective, controlled, randomized, multicentre, single-blind study is to compare the rate of intragastric migration of 2 types of esophageal stents with and without an anti-migration device placed for locally advanced or metastatic malignant stenosis of the gastroesophageal junction.",[446,70],"Stent Migration",[446,70,448,449,450],"Esophageal Stenosis","Esophageal cancer","Endoscopy","2024-07-27",{"date":453,"type":46},"2024-07-30",{"date":455,"type":46},"2022-09-01",{"date":457,"type":20},"2025-09-01",{"name":459,"class":141},"Société Française d'Endoscopie Digestive",{"id":461,"slug":462,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":363,"enrollmentInfo":467,"targetDuration":4,"studyType":21,"phases":469,"briefSummary":470,"conditions":471,"keywords":4,"overallStatus":180,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":280},"100534641","phase-2-efficacy-and-safety-of-sintilimab-combined-with-nab-paclitaxel-and-tegio-ats-as-first-line-treatment-of-unresectable-locally-advanced-recurrent-or-metastatic-adenocarcinoma-of-gastric-and-gastroesophageal-junctiona-phase-ii-clinical-study-100534641","NCT06241469","Efficacy and Safety of Sintilimab Combined With Nab-paclitaxel and Tegio (aTS) as First-line Treatment of Unresectable Locally Advanced, Recurrent or Metastatic Adenocarcinoma of Gastric and Gastroesophageal Junction，a Phase II Clinical Study","Efficacy and Safety of Sintilimab Combined With Nab-paclitaxel and Tegio (aTS) as First-line Treatment of Unresectable Locally Advanced, Recurrent or Metastatic Adenocarcinoma of Gastric and Gastroesophageal Junction (CZTU-1)：a Phase II Clinical Study","Inclusion Criteria:\n\n1. Non resectable locally advanced, recurrent, or metastatic adenocarcinoma at the junction of the stomach and esophagus (including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma) confirmed by histopathological examination.\n2. Age ≥ 18 years old.\n3. The ECOG PS score is 0 or 1.\n4. The time from the end of previous (new) adjuvant chemotherapy\u002Fradiotherapy to disease recurrence is greater than 6 months.\n5. Palliative treatment for local lesions (non target lesions) should last for more than 2 weeks until randomization.\n6. According to RECIST v1.1, there should be at least one measurable or evaluable lesion.\n7. Can provide archived or fresh pathological tissues within 6 months from the signing of the informed consent document for PD-L1 testing and obtain test results.\n8. Having sufficient organ and bone marrow functions, defined as follows:\n\n1\\) Blood routine: Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL; Platelet count (PLT)≥ 100 × 109\u002FL; Hemoglobin content (HGB) ≥ 8.0 g\u002FdL. No G-CSF, GM-CSF, Meg CSF, TPO, EPO, red blood cell transfusions or platelet transfusions were not used within the first 7 days of the examination.\n\n2\\) Liver function: Patients without liver metastasis require serum total bilirubin (TBIL) ≤ 1.5 × Normal upper limit (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN. Patients with liver metastasis require serum total bilirubin (TBIL) ≤ 1.5 × Normal upper limit (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN.\n\n3\\) Renal function: Glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin(Calculate using the CKD-EPI formula) 4) Adequate coagulation function is defined as an international standardized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 × ULN; If the subject is receiving anticoagulant treatment, as long as the PT is within the range of anticoagulant drugs prescribed; 5) Urinary routine: Urinary protein\\\u003C2+; If the urine protein is ≥ 2+, the 24-hour urine protein quantification needs to be\\\u003C1.0 g.\n\n9\\. Expected survival time ≥ 24 weeks. 10. Female participants of childbearing age or male participants whose sexual partners are female participants of childbearing age are required to take effective contraceptive measures throughout the entire treatment period and 6 months after the treatment period.\n\n11\\. Sign a written informed consent form and be able to comply with the visitation and related procedures stipulated in the plan.\n\nExclusion Criteria:\n\n1. Known signs of active bleeding in the lesion (excluding positive fecal occult blood).\n2. Obstruction of the cardia and pylorus can affect the patient's eating and gastric emptying, or hinder the swallowing of medication.\n3. Diagnosed as HER2 positive adenocarcinoma at the junction of the stomach and esophagus.\n4. Previously received systematic treatment for advanced or metastatic adenocarcinoma at the junction of the stomach and esophagus.\n5. Peripheral neurotoxicity has not recovered to level 1 after previous treatment.\n6. It is known that dihydropyrimidine dehydrogenase (DPD) is deficient (or has experienced mucosal toxicity of grade 3 or higher in previous fluorouracil containing treatments).\n7. Known to be allergic to any monoclonal antibody or chemotherapy drug (tigio, albumin bound paclitaxel) formulation component (having experienced grade 3 or above allergic reactions).\n8. Previously exposed to any anti-PD-1 or anti-PD-L1, PD-L2, CD137, CTLA-4 antibody therapy, or any other antibody or drug targeting T cell co stimulation or checkpoint pathways.\n9. Participate in another intervention clinical study at the same time, unless participating in an observational (non intervention) clinical study or in the follow-up stage of an intervention study.\n10. Within 2 weeks before the first administration, systemic systemic treatment with Chinese herbal medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) with anti-tumor indications has been received;\n11. Within 4 weeks prior to the first dose of study treatment, immunosuppressive drugs were used, excluding local corticosteroids administered through nasal spray, inhalation, or other routes, or systemic corticosteroids administered at physiological doses (i.e. no more than 10 mg\u002Fday of prednisone or equivalent doses of other corticosteroids), or steroids were used to prevent contrast agent allergies.\n12. Within 4 weeks prior to the first dose of study treatment or planned to receive attenuated live vaccines during the study period.\n\n    Note: It is allowed to receive inactivated viral vaccines for seasonal influenza within 4 weeks before the first administration; But it is not allowed to receive attenuated live influenza vaccines;\n13. Have undergone major surgical procedures (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment, or are expected to require major surgery during the study treatment period; Laparoscopic exploration surgery was performed within 2 weeks prior to the first dose of study treatment.\n14. Toxicity (excluding hair loss, non clinically significant, and asymptomatic laboratory abnormalities) at level 0 or 1 of the National Cancer Institute Common Standard Terminology 5.0 (NCI CTCAE v5.0) caused by previous anti-tumor treatments prior to the initial study treatment.\n15. It is known that there are symptomatic central nervous system metastases and\u002For cancerous meningitis. For subjects with brain metastases who have received previous treatment, if their condition is stable (no evidence of imaging progression at least 4 weeks prior to the first administration of the trial treatment, and repeated imaging examinations confirm no evidence of new or enlarged brain metastases), and they do not require steroid treatment for at least 14 days prior to the first administration of the trial treatment, they can participate in the trial. This exception does not include cancerous meningitis, which should be excluded regardless of its stable clinical condition.\n16. Any ascites that can be detected during physical examination, ascites that have been previously treated or still require treatment, with only a small amount of ascites shown on imaging but no symptoms, can be selected.\n17. Patients with equal amount of fluid accumulation in both sides of the chest cavity, or a large amount of fluid accumulation in one side of the chest cavity, or those who have caused respiratory dysfunction and require drainage.\n18. Patients with bone metastases who are at risk of paralysis.\n19. Known or suspected autoimmune disease or medical history of the disease in the past two years (vitiligo, psoriasis, alopecia or Grave's disease that does not need systematic treatment in the past two years, hypothyroidism that only needs thyroid hormone replacement therapy and type I diabetes patients that only need insulin replacement therapy can be included in the group).\n20. Known history of primary immunodeficiency.\n21. Known to have active pulmonary tuberculosis.\n22. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n23. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV antibody positive).\n24. Severe infections that are active or poorly controlled clinically.\n25. Symptomatic congestive heart failure (New York Heart Association classification II-IV) or symptomatic or poorly controlled arrhythmia.\n26. Uncontrolled arterial hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg) even after receiving standardized treatment.\n27. Have experienced any arterial thromboembolism events, including myocardial infarction, unstable angina, cerebrovascular accidents, or transient ischemic attacks, within the 6 months prior to enrollment for treatment.\n28. Significant malnutrition (a weight loss of 5% within 1 month of signing the informed consent form, a weight loss of\\>15% within 3 months, or a decrease of 1\u002F2 or more in food intake within 1 week), except for malnutrition correction of more than 4 weeks before the first dose of study drug administration.\n29. A history of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within the 3 months prior to enrollment (implantable venous infusion port or catheter-related thrombosis, or superficial venous thrombosis is not considered \"severe\" thromboembolism).\n30. Uncontrolled metabolic disorders or other non malignant organ or systemic diseases or secondary reactions to cancer, which can lead to higher medical risk and\u002For uncertainty in survival evaluation.\n31. Hepatoencephalopathy, hepatorenal syndrome, or Child Pugh B grade or more severe cirrhosis.\n32. History of tumor related intestinal obstruction (within 3 months prior to the signing of informed consent) or the following diseases: inflammatory bowel disease or extensive bowel resection (partial or extensive bowel resection with concurrent chronic diarrhea), Crohn's disease, ulcerative colitis.\n33. Known to have acute or chronic active hepatitis B virus (HBsAg positive and HBV DNA viral load ≥ 200 IU\u002FmL or ≥ 103 copy number\u002FmL) or acute or chronic active hepatitis C virus (HCV antibody positive and HCV RNA positive).\n34. Active syphilis infected individuals who require treatment.\n35. There is a history of gastrointestinal perforation and\u002For fistula within the 6 months prior to enrollment in the study, except for patients with gastric cancer perforation who have undergone surgical resection of the primary lesion of gastric cancer.\n36. Suffering from interstitial lung disease that requires steroid hormone treatment.\n37. History of other primary malignant tumors, excluding:\n\n    * Complete remission (CR) of malignant tumors for at least 2 years prior to enrollment and no additional treatment required during the study period;\n    * Non melanoma skin cancer or malignant freckle like nevi that have been adequately treated and have no evidence of disease recurrence;\n    * In situ cancer with sufficient treatment and no evidence of disease recurrence.\n38. Pregnant or breastfeeding female patients.\n39. Other acute or chronic diseases, mental illnesses, or abnormal laboratory test values that may lead to increased risk of study participation or drug administration, or interference with the interpretation of study results, and the inclusion of patients as ineligible to participate in this study based on the researcher's judgment.",{"count":468,"type":20},40,[23],"The goal of this clinical trial is to find better protocal for adenocarcinoma of the gastric and gastroesophageal juncion.\n\nThe main question is aim to answer is:\n\n1\\. The efficacy and safety of PD-1 monoclonal antibody (Sintilimab) combined with nab-paclitaxel and S-1 in the first-line treatment of advanced gastric and gastroesophageal junction adenocarcinoma.\n\nParticipants will be given PD-1 monoclonal antibody, nab-paclitaxel and tegio.",[27,70,294],"2024-01-28",{"date":474,"type":46},"2024-02-05",{"date":476,"type":20},"2024-02-03",{"date":478,"type":20},"2027-02-02",{"name":480,"class":141},"Wu Jun",{"id":482,"slug":483,"hasResults":11,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":198,"phases":4,"briefSummary":490,"conditions":491,"keywords":492,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":280},"100488770","gastroesophageal-tumor-immune-microenvionnment-gotim-100488770","NCT05644431","GastrOesophageal Tumor, Immune Microenvionnment (GOTIM)","A Prospective Clinicobiological Cohort Study Aiming to Decipher Tumor Immune Microenvironment Evolution Under Standard Chemotherapy in Localized and Resectable Gastric and Gastroesophageal Junctional Adenocarcinomas","GOTIM","Inclusion Criteria:\n\n* Male or female patient \\> 18 years of age on day of signing informed consent.\n* Histologically proven non-metastatic resectable gastric and gastroesophageal junction adenocarcinoma, Stage IB to III to be treated with standard neoadjuvant treatment.\n* Surgery of primary tumor to be done at Centre Léon Bérard.\n* Availability of archival FFPE tumor block from initial diagnosis with at least 20% of tumor cells.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2.\n* Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.\n* Patients must be covered by a medical insurance.\n\nExclusion Criteria:\n\n* Any condition contraindicated with blood sampling procedures required by the protocol.\n* Known additional malignancy that is progressing or requires active treatment. Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer\n* Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.\n* Pregnant or breast-feeding woman.",{"count":311,"type":20},"This trial is a prospective, monocentric, non-therapeutic, interventional cohort study aiming to decipher the immune TME through standard neoadjuvant CT in resectable G\u002FGEJ adenocarcinomas. This study will also longitudinally monitor MRD during neoadjuvant and adjuvant therapy.",[70],[493,494],"junctional adenocarcinomas","immune microenvironment","2023-08-29",{"date":497,"type":46},"2023-08-30",{"date":499,"type":46},"2023-07-19",{"date":501,"type":20},"2028-01-15",{"name":503,"class":141},"Centre Leon Berard",{"id":505,"slug":506,"hasResults":11,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":11,"sex":16,"minAge":511,"maxAge":363,"enrollmentInfo":512,"targetDuration":4,"studyType":21,"phases":513,"briefSummary":514,"conditions":515,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":524,"locationsCount":280},"100415374","ajuvant-chemotherapy-and-immunotherapy-in-patients-with-esophageal-esophageal--gastric-junction-cancer-100415374","NCT04688801","Ajuvant Chemotherapy and Immunotherapy in Patients With Esophageal, Esophageal- Gastric Junction Cancer","Ajuvant Chemotherapy and Immunotherapy in Patients With Esophageal, Esophageal- Gastric Junction Cancer With or Without Preoperative Chemotherapy With High Risk for Recurrence (N+ and\u002F or R1)","Inclusion Criteria:\n\nHistologically proven esophageal or EG-junction carcinoma (Siewert I-II). The heart and lung function can tolerate surgery. The cancer is resectable and incurable therapy will be perfomed.\n\nExclusion Criteria:\n\nEG-junction carcinoma (Siewert III). M1 stage according to the current (8th) version of TNMclassification system. The heart and lung function can't tolerate surgery. R2 Resection Status.","25 Years",{"count":19,"type":20},[121],"Surgery with or without neoadjuvant therapy is usually used as the treatment for resectable esophageal cancer or esophageal- gastric junction cancer. Patients who have a poor response to neoadjuvant therapy and have an incomplete (R1) resection or have metastatic lymph nodes in the resection specimen (N+) are especially at risk of recurrence, to continue with the chemotherapy± radiotherapy is often used in these cases. However, the overall survival is still poor. We designed a prospective randomized controlled tial to study whether immunotherapy could be used with chemotherapy after surgery to improve overall survival. The primary endpoint ofthe study is disease free survival, with secondary endpoints of overall survival, safety and toxicity, and quality of life.",[28,29,516,517],"Immunotherapy","Adjuvant","2022-11-14",{"date":520,"type":46},"2022-11-16",{"date":522,"type":46},"2020-07-01",{"date":50,"type":20},{"name":525,"class":141},"The Second Hospital of Shandong University"]