[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastric-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastric-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,374,0,25,[9,48,91,125,153,183,251,282,307,338,366,391,416,435,465,488,516,552,580,610,654,678,698,726,751],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053266","combination-of-ct-and-ultrasound-radiomics-combined-with-liquid-biopsy-to-predict-neoadjuvant-chemotherapy-response-in-patients-with-locally-advanced-gastric-cancer-100053266",false,"NCT07697079","Combination of CT and Ultrasound Radiomics Combined With Liquid Biopsy to Predict Neoadjuvant Chemotherapy Response in Patients With Locally Advanced Gastric Cancer","Combination of CT and Ultrasound Radiomics Combined With Liquid Biopsy to Predict Neoadjuvant Chemotherapy Response in Patients With Locally Advanced Gastric Cancer: A Prospective Study","Inclusion Criteria:\n\n1. Capable of understanding the study and voluntarily signing the written informed consent form (ICF) prior to any study-specified research procedures.\n2. Aged ≥18 and ≤80 years old at the time of ICF signing.\n3. Pathologically confirmed locally advanced gastric cancer (LAGC, cT2NxM0-cT4NxM0) with clinical indications for neoadjuvant chemotherapy.\n4. Completion of gastrointestinal contrast-enhanced ultrasound and contrast-enhanced abdominal CT before neoadjuvant chemotherapy.\n5. Provision of peripheral blood samples before chemotherapy (for genetic and protein detection).\n6. Availability of postoperative pathological specimens for TRG grading after standardized neoadjuvant chemotherapy.\n7. Willing and able to comply with all study protocol requirements.\n\nExclusion Criteria:\n\n1. Diagnosis of non-primary gastric cancer.\n2. Incomplete imaging data, failure to collect peripheral blood samples, or substandard sample quality.\n3. Discontinued chemotherapy, modified treatment regimen, or lack of complete postoperative pathological assessment.\n4. Unavailable follow-up data precluding evaluation of chemotherapy response.\n5. Concurrent participation in another clinical trial; or any other conditions judged by investigators to warrant subject withdrawal, including severe comorbidities requiring simultaneous treatment (psychiatric disorders included), alcohol dependence, substance abuse, or familial\u002Fsocial factors that may compromise subject safety or treatment compliance.","ALL","18 Years","80 Years",{"count":21,"type":22},300,"ESTIMATED","OBSERVATIONAL","This prospective cohort study aims to construct an artificial intelligence (AI)-derived predictive model for neoadjuvant chemotherapy response prediction in patients with locally advanced gastric cancer based on preoperative ultrasound (US), computed tomography (CT) images and liquid biopsy. Additionally, we explore the potential biological mechanisms behind this model.",[26],"Gastric Cancer",[28,29,30,31,32,33,34],"locally advanced gastric cancer","ultrasound","CT","liquid biopsies","radiomics","neoadjuvant chemotherapy","Pathological response","NOT_YET_RECRUITING","2026-07-09",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":22},"2027-02-01",{"date":43,"type":22},"2030-12-31",{"name":45,"class":46},"Liu Yang","OTHER",1,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"100597545","distance-based-exercise-to-preserve-function-and-prevent-disability-100597545","NCT07059884","Distance-Based Exercise to Preserve Function and Prevent Disability","DEFEND","Inclusion Criteria:\n\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must have histologically confirmed diagnosis of one of the following cancers: anus, bladder, breast, cervix, colon\u002Frectum, endometrium, esophagus, gallbladder, head\u002Fneck, kidney, liver, lung, ovary, pancreas, prostate, sarcoma, stomach\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must be initiating outpatient cytotoxic chemotherapy for curative intent of at least 10 weeks duration (with or without concurrent radiation, immunotherapy, or other targeted therapy). Patients must be enrolled and baseline measures collected on or before administration of their second cycle of cytotoxic therapy. Patients receiving outpatient cytotoxic chemotherapy for curative intent in the neoadjuvant or adjuvant setting are eligible. Patients receiving definitive chemoradiation for the tumors listed above, are also eligible. Regimens of immunotherapy or monoclonal antibodies ONLY are not eligible\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age 18-64 years\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have metastatic cancer\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot be pregnant, because this study involves remotely delivered exercise, and cannot be breast-feeding as patients must be receiving cytotoxic chemotherapy, during which breast-feeding is contraindicated\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of current alcohol, substance abuse, or dementia\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Engaged in full time gainful employment of at least 30 hours per week at the time of cancer diagnosis\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Currently no self-report of engagement in competitive sports (e.g. not training for running races, triathlons, etc.) AND no self-report of twice weekly progressive resistance exercise training for at least 3 consecutive months within the past year\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Self-reported ability to walk for 6 minutes (use of assistive devices will be allowed)\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not participating in another weight loss, physical activity, or dietary intervention clinical trial\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Predicted 6MWT distance of 550 meters or less\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Concurrent enrollment in treatment or supportive care trials (other than those focused on weight loss or exercise) is allowed with the permission of the Alliance Executive Officer and both studies' study chairs\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eligibility is restricted to individuals who can comprehend and read English given that participation in the study will require the ability to read intervention materials and work with a coach through telehealth sessions\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): The trial is unable to accommodate the needs of deaf or blind participants as the study relies on language and visualization of exercise through telehealth sessions\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Clinicians and research staff from enrolling sites who meet following criterion will be deemed eligible to participate as a clinical stakeholder:\n\n  \\* Providing clinical care for participating patients on this study\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Ability to speak and understand English\n\nExclusion Criteria:\n\n\\-",{"count":56,"type":22},104,"INTERVENTIONAL",[59],"NA","This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home. Treatments for cancer can cause side effects such as fatigue and loss of strength. These side effects can make it difficult to work, take care of family, and do other things the patient wants to do. Preliminary research shows that exercise can help prevent some of these side effects, but it can be more difficult to start an exercise program when a patient is receiving cancer treatment. The exercise program in this study is delivered through telehealth (TH) video calls. The TH sessions are delivered by trained staff that supervise resistance exercises. The trained staff also provide guidance to the patient on completing unsupervised aerobic sessions on their own. This may be a successful way to deliver an exercise program and make it easier for cancer patients to exercise in their own home during treatment.",[62,63,64,65,66,67,68,69,70,26,71,72,73,74,75,76,77,78,79],"Localized Malignant Solid Neoplasm","Anal Cancer","Bladder (Urothelial, Transitional Cell) Cancer","Breast Cancer","Cervical Cancer","Colon Cancer","Endometrial Cancer","Esophageal Cancer","Gall Bladder Cancer","Kidney Cancer","Liver Cancer","Lung Cancer","Head and Neck Cancer","Ovarian Cancer","Pancreatic Cancer","Prostate Cancer","Rectal Cancer","Sarcoma","RECRUITING","2026-07-01",{"date":83,"type":39},"2026-07-02",{"date":85,"type":39},"2026-02-11",{"date":87,"type":22},"2027-08-31",{"name":89,"class":46},"Alliance for Clinical Trials in Oncology",18,{"id":92,"slug":93,"hasResults":12,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":57,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":124},"100626103","phase-3-sonesitatug-vedotin-in-combination-with-capecitabine-with-or-without-rilvegostomig-in-participants-with-advanced-or-metastatic-gastric-gastroesophageal-junction-or-esophageal-adenocarcinoma-expressing-claudin182-100626103","NCT07431281","Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2","A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced\u002FMetastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)","Inclusion Criteria:\n\n* Capable of giving signed informed consent\n* Participant must be 18 years or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent.\n* Previously untreated histologically documented unresectable, locally advanced, or metastatic gastric, GEJ, or distal esophagus (distal third of the esophagus) adenocarcinoma\n* Positive CLDN18.2 expression, as determined prospectively by central IHC testing\n* Confirmed PD-L1 CPS status by central IHC testing and ICI eligibility per investigator judgement is required to determine cohort eligibility as described below:\n\n  1. Cohort 1: PD-L1 positive as determined by central IHC testing and the participant is deemed ICI eligible per investigator judgement.\n  2. Cohort 2: PD-L1 negative as determined by central IHC testing OR the participant is ICI ineligible\n* ECOG performance status of 0 or 1 with no deterioration to \\> 1 over the previous 2 weeks prior to baseline at screening and prior to randomisation.\n* Minimum life expectancy of ≥ 12 weeks.\n* At least one lesion (measurable and\u002For non-measurable) that can be accurately assessed by the investigator based on RECIST 1.1.\n* Adequate organ and bone marrow function as specified in the protocol\n* Body weight ≥ 35 kg.\n* Sex and contraceptive requirements\n\nExclusion Criteria:\n\n* Known HER2-positive status\n* Significant or unstable gastric bleeding and\u002For untreated gastric ulcers.\n* Active or history of autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment or assessed by investigator as not appropriate to participate due to undue risk are excluded.\n* CNS pathology\n* Clinically significant pleural effusions or ascites and\u002For pleural effusions or ascites that require drainage, peritoneal shunt, or indwelling catheter\u002Fdrain.\n* Require parenteral nutrition support due to gastric or gastrointestinal obstruction.\n* Peripheral neuropathy, sensory or motor, ≥ CTCAE Grade 2 at screening.\n* Persistent toxicities caused by previous anticancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline.\n* Cardiac abnormalities as outlined in the protocol\n* Uncontrolled diabetes or diabetic neuropathy within 3 months prior to randomisation.\n* Infectious disease including active hepatitis A infection; uncontrolled hepatitis B and\u002For chronic or active hepatitis B with HBV DNA ≥ 100 IU\u002FmL; Known chronic, active, or uncontrolled hepatitis C; HIV infection that is not well controlled\n* Known partial or total DPD enzyme deficiency",{"count":99,"type":22},2130,[101],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in first-line (1L) Claudin18.2 (CLDN18.2)-positive, human epidermal growth factor receptor 2 (HER2)-negative, gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.",[26,104,69],"Gastroesophageal Junction Adenocarcinoma",[106,107,108,109,110,111,112,113,114],"Advanced Gastroesophageal Junction (GEJ) Adenocarcinoma,","Advanced Gastric Adenocarcinoma,","Advanced Esophageal Adenocarcinoma,","Metastatic Gastric Adenocarcinoma,","Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma,","Metastatic Esophageal Adenocarcinoma,","Claudin 18.2,","PD-L1,","Human epidermal growth factor receptor 2 (HER2) Negative","2026-06-30",{"date":81,"type":39},{"date":118,"type":39},"2026-02-03",{"date":120,"type":22},"2031-10-27",{"name":122,"class":123},"AstraZeneca","INDUSTRY",286,{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":57,"phases":134,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"100572300","phase-3-study-of-tdxd-chemotherapy-pembrolizumab-and-trastuzumab-in-first-line-metastatic-her2-positive-gastric-or-gastroesophageal-junction-cancer-100572300","NCT06731478","Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer","A Multicenter, Randomized, Open-Label, Phase 3 Trial of Trastuzumab Deruxtecan (Enhertu®) Plus Chemotherapy Plus or Minus Pembrolizumab Versus Chemotherapy Plus Trastuzumab Plus or Minus Pembrolizumab as First-Line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Gastric Or Gastroesophageal Junction (GEJ) Cancer (Destiny-Gastric05)","Inclusion Criteria\n\n1. Sign and date the Tissue Prescreening ICF, prior to central HER2 and PD-L1 CPS testing. Sign and date the Main Screening ICF, prior to the start of any trial-specific qualification procedures. Sign and date the Optional PGx ICF (included in the Main Screening ICF) prior to any PGx procedure.\n2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old.\n3. Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma histologically confirmed by pathology report. Prior treatment in the perioperative and\u002For adjuvant setting is permissible, provided there is \\>6 months between the end of perioperative or neoadjuvant treatment and the diagnosis of recurrent disease.\n\n   Note: Prior use of IO (ie, anti-PD-1\u002FPD-L1) therapy in the (neo)adjuvant setting is allowed as long as there is \\>6 months between the end of IO therapy and the diagnosis of recurrent disease.\n4. Centrally determined HER2-positive (IHC 3+ or IHC 2+\u002FISH-positive) gastric or GEJ cancer as classified by the American Society of Clinical Oncology-College of American Pathologists for GC on a tumor biopsy as detected by prospective central test on new (core, incisional, excisional biopsy) or existing tumor tissue taken at the time of diagnosis of locally advanced or metastatic disease.\n\n   Note: Archival samples taken from a previous diagnostic or surgical biopsy not previously irradiated can be accepted. Details pertaining to tumor tissue submission can be found in the Study Laboratory Manual.\n5. Centrally determined tumor PD-L1 CPS using the PD-L1 assay:\n\n   * For the Main Cohort: PD-L1 CPS ≥1\n   * For the Exploratory Cohort: PD-L1 CPS \\\u003C1\n6. All participants must provide a tumor sample for tissue-based IHC staining to centrally determine HER2 expression, PD-L1 CPS, and other correlatives. The mandatory FFPE or new biopsy tumor sample can be from either the primary tumor or metastatic biopsy. Specimens with limited tumor content (as centrally determined) and cytology samples are inadequate for defining tumor HER2 and PD-L1 status.\n7. At least 1 target measurable lesion on CT or MRI, assessed by the investigator based on RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.\n8. LVEF ≥50% within 28 days before randomization.\n\nExclusion Criteria\n\n1. Prior exposure to other HER2-targeting therapies (including ADCs).\n2. Lack of physiological integrity of the upper gastrointestinal tract (ie, severe Crohn disease that results in malabsorption) or malabsorption syndrome that would preclude feasibility of oral chemotherapy for participants planned to be offered capecitabine as part of the study treatment.\n3. Known total or partial DPD enzyme deficiency. Note: Screening for DPD enzyme deficiency is required only in regions\u002Fcountries where DPD testing is SoC and with unknown DPD status. For regions\u002Fcountries where DPD testing is not SoC, local practice should be followed. In Spain and Italy, screening for DPD enzyme deficiency is mandatory for all participants with unknown DPD status.\n4. Contraindications to trastuzumab, 5-FU, capecitabine, cisplatin, or oxaliplatin treatment as per local label.\n5. Medical history of myocardial infarction within 6 months before randomization or symptomatic CHF (New York Heart Association Class II to IV). Participants with troponin levels above ULN at Screening (as defined by the manufacturer) and without any myocardial infarction -related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction.\n6. Has a corrected QT interval (QTcF) prolongation to \\>470 ms (females) or \\>450 ms (males) based on the average of the screening triplicate 12-lead ECG.\n7. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening\n8. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc).",{"count":133,"type":22},726,[101],"This clinical trial is designed to assess the efficacy and safety of the triplet combination of trastuzumab deruxtecan (ENHERTU, T-DXd, DS-8201a) plus a fluoropyrimidine plus pembrolizumab versus standard of care (SoC) chemotherapy plus trastuzumab plus pembrolizumab as first-line therapy in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS ≥1 gastric or GEJ cancer in the Main Cohort. An Exploratory Cohort will also be evaluated to assess the efficacy and safety of T-DXd plus a fluoropyrimidine versus SoC chemotherapy plus trastuzumab in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS \\\u003C1 gastric or GEJ cancer.",[26,137],"Gastroesophageal Junction Cancer",[139,140,141,142,143],"Enhertu","Trastuzumab Deruxtecan","Chemotherapy","DS-8201a","HER2 positive","2026-06-29",{"date":81,"type":39},{"date":147,"type":39},"2025-02-27",{"date":149,"type":22},"2030-02-01",{"name":151,"class":123},"Daiichi Sankyo",250,{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":57,"phases":163,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":47},"100644605","comprehensive-perioperative-program-based-on-prehabilitation-nutritional-intervention-and-psychological-support-for-patients-with-locally-advanced-operable-oesophagogastric-cancer-100644605","NCT07671625","Comprehensive Perioperative Program Based on Prehabilitation, Nutritional Intervention and Psychological Support for Patients With Locally Advanced Operable Oesophagogastric Cancer","A Comprehensive Preoperative and Postoperative Program Consisting Of Active Physical Therapy, A Comprehensive Nutritional Plan, And Psychological Support For Patients With Locally Advanced, Resectable Cancer Of The Esophagus, Gastroesophageal Junction, and Stomach","OESOFIT","Inclusion Criteria:\n\n* Consent to participate in the study\n* Age ≥ 18 years\n* Patients with locally advanced esophageal or gastric cancer indicated for comprehensive perioperative treatment\n* Resectable disease\n* ECOG performance status 0-2\n* Ability to participate in a fitness program\n* Willingness to follow a nutritional plan and recommendations\n\nExclusion Criteria:\n\n* Disseminated disease",{"count":162,"type":22},60,[59],"Perioperative chemotherapy (CHT) or CHT\u002FRT combined with surgery is the standard therapeutic approach for the treatment of locally advanced cancer of the esophagus, gastroesophageal junction (GEJ), and stomach. Comprehensive cancer treatment is associated with high perioperative morbidity and mortality. Serious postoperative complications occur in up to 20-80% of patients undergoing esophagectomy. The impact of nutritional status and overall physical condition on surgical outcomes and overall treatment has been demonstrated many times. The concept of pre-rehabilitation\u002Fpre-optimization, which involves establishing an individualized nutritional plan, monitoring and managing physical activity, and providing comprehensive supportive oncological and psychological care as early as during neoadjuvant CHT or CHT\u002FRT, is a prerequisite for improving perioperative and 30-day postoperative morbidity and mortality.",[166,137,26],"Locally Advanced Esophageal Cancer",[168,169,170,171,172,173],"autonomic nervous system","physiotherapy","gastric cancer","nutritional intervention","psychologic support","esophageal cancer","2026-06-25",{"date":176,"type":39},"2026-06-26",{"date":178,"type":39},"2023-05-02",{"date":180,"type":22},"2026-12-31",{"name":182,"class":46},"Masaryk Memorial Cancer Institute",{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":190,"sex":17,"minAge":191,"maxAge":192,"enrollmentInfo":193,"targetDuration":19,"studyType":23,"phases":4,"briefSummary":195,"conditions":196,"keywords":233,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":250},"100210159","integrated-cancer-repository-for-cancer-research-100210159","NCT02012699","Integrated Cancer Repository for Cancer Research","iCaRe2","Inclusion Criteria\n\n* Diagnosis\u002Fhistory of cancer\n* Risk for developing cancer or suspicious clinical findings\n* No history of cancer (normal control registry)\n* Able to provide informed consent\n* 19 years of age or older\n* English or Spanish speaking individuals\n\nExclusion Criteria\n\n* Unable to provide informed consent because of cognitive impairment\n* Non-English or non-Spanish speaking individuals",true,"19 Years","110 Years",{"count":194,"type":22},999999,"The iCaRe2 is a multi-institutional resource created and maintained by the Fred \\& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.",[76,197,73,69,198,67,78,199,63,200,201,202,26,72,203,204,205,206,207,71,208,77,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,65,225,226,79,227,228,75,68,229,230,231,232],"Thyroid Cancer","Thymus Cancer","Gastrointestinal Stromal Tumors","Bile Duct Cancer","Duodenal Cancer","Gallbladder Cancer","Small Intestine Cancer","Peritoneal Surface Malignancies","Familial Adenomatous Polyposis","Lynch Syndrome","Bladder Cancer","Penile Cancer","Testicular Cancer","Ureter Cancer","Urethral Cancer","Hypopharyngeal Cancer","Laryngeal Cancer","Lip Cancer","Oral Cavity Cancer","Nasopharyngeal Cancer","Oropharyngeal Cancer","Paranasal Sinus Cancer","Nasal Cavity Cancer","Salivary Gland Cancer","Skin Cancer","Central Nervous System Tumor","Central Nervous System Cancer","Mesothelioma","Leukemia","Melanoma","Unknown Primary Tumor","Multiple Myeloma","Vaginal Cancer","Neuroendocrine Tumors","Plasma Cell Dyscrasia","Healthy Control",[76,197,234,235,236,237,238,239,240,241,65,242,231,232],"Esophageal cancer","Thymus cancer","Pancreatic tumor","Esophageal tumor","Thymus tumor","Thyroid Tumor","Thyroid Nodule","Lung Tumor","Neuroendocrine tumor",{"date":144,"type":39},{"date":245,"type":39},"2013-11-01",{"date":247,"type":22},"2099-12",{"name":249,"class":46},"University of Nebraska",42,{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":190,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":261,"conditions":262,"keywords":265,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":47},"100644983","oral-fecal-and-intratumoral-microbiome-atlas-in-colombian-patients-with-advanced-solid-tumors-receiving-first-line-immunotherapy-100644983","NCT07676461","Oral, Fecal and Intratumoral Microbiome Atlas in Colombian Patients With Advanced Solid Tumors Receiving First-Line Immunotherapy","Atlas of the Oral, Fecal and Intratumoral Microbiome of Colombian Patients With Advanced Solid Tumors Candidates for First-Line Immunotherapy - Initial Phase of a Project With Latin American Projection","ATLAS","Inclusion Criteria:\n\n* Age 18 years or older.\n* Histologically confirmed advanced (stage III unresectable or IV) gastric, colorectal, breast, cervical or head-and-neck cancer.\n* Candidate for first-line immunotherapy per current clinical guidelines.\n* Available FFPE tumor block in institutional or reference pathology archive.\n* Able to provide saliva and stool samples at V0 and follow-up.\n* ECOG performance status within protocol limits; life expectancy over 3 months.\n* Cognitive capacity to give informed consent; signed EVA-BIOBANCO and Atlas consents.\n\nInclusion Criteria (healthy controls)\n\n* No prior cancer diagnosis.\n* No active autoimmune disease; no inflammatory bowel disease.\n* No antibiotics, invasive dental treatment, immunosuppressants or corticosteroids in the prior 3 months; no severe active periodontal disease.\n\nExclusion Criteria:\n\n* Systemic antibiotics within 3 months (except short course under 5 days for uncomplicated infection).\n* Probiotics or prebiotics within 30 days.\n* Chronic proton-pump inhibitors for more than 3 continuous months.\n* Inflammatory bowel disease (Crohn, ulcerative colitis) or extensive bowel resection.\n* Pregnancy or lactation.\n* BMI under 18.5 or over 40 kg\u002Fm².\n* Uncontrolled diabetes (HbA1c at or above 9% in prior 3 months).\n* Invasive dental treatment within 3 months.\n* Patients: simultaneous randomized trial of a non-INVIMA-approved experimental immunotherapy; or no evaluable FFPE block meeting quality thresholds.\n* Inability to ensure 12-month clinical follow-up.",{"count":260,"type":22},150,"This is a prospective observational cohort study conducted at Fundación CTIC in Bogotá, Colombia. It characterizes the oral, fecal and intratumoral microbiome of Colombian adults with advanced solid tumors (gastric, colorectal, breast, cervical and head-and-neck cancer) who receive first-line immunotherapy as standard of care, and compares them with healthy volunteers. Using multi-omics (HiFi metagenomics, 16S, tumor RNA-Seq and untargeted metabolomics), the study aims to identify microbial signatures associated with treatment response and survival, building the initial Colombian cohort of a Cancer Microbiome Atlas with Latin American projection.",[26,263,65,66,264],"Colorectal Cancer","Head and Neck Cancer (H&N)",[266,267,268,269,270,271,272,273],"Microbiome","Cancer","Immunotherapy","Tumor microenvironment","Biomarkers","Metagenomics","Transcriptomics","Metabolomics","2026-06-24",{"date":115,"type":39},{"date":277,"type":39},"2026-06-11",{"date":279,"type":22},"2029-08-30",{"name":281,"class":46},"Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo",{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":57,"phases":292,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":306},"100542694","phase-3-combination-of-immune-checkpoint-in-locally-advanced-or-metastatic-msidmmr-esogastric-adenocarcinomas-100542694","NCT06346197","Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI\u002FdMMR Esogastric Adenocarcinomas","A Multicenter, Randomised, Comparative, Open-label Phase III Aiming to Compare the Survival of Patients With Locally Advanced or Metastatic MSI\u002FdMMR Esogastric Adenocarcinomas Treated by a Combination of Immune Checkpoint Inhibitors (Botensilimab + Balstilimab) Versus the Standard of Care (FOLFOX\u002FXELOX + Nivolumab)","CIME","Inclusion Criteria:\n\n* Male or female patient ≥18 years of age at time of informed consent form signature.\n* Patient with MSI-H\u002FdMMR, HER2 negativeadvanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5. Note :The claudin 18.2 status must be known and documented before inclusion.\n* Patient to be treated with a first line therapy for locally advanced\u002Fmetastatic disease.\n* No prior treatment with chemotherapy for locally advanced\u002Fmetastatic disease.\n\n  o Note - adjuvant or neoadjuvant chemotherapy is allowed providing that 6 months have relapsed between completion of adjuvant chemotherapy and recurrence.\n* Measurable disease (outside any previous irradiated field within the past 6 months) defined as at least one unidimensional lesion that can be accurately measured as ≥ 10 mm with CT scan according to RECIST V1.1 (Appendix 01).\n\n  * Note: Lesions intended to be biopsied should not be defined as target lesions.\n  * Note: previously irradiated lesions can be selected as target lesion only if recurrence\u002FPD is documented after RT.\n* Patient with PS ECOG 0 or 1 (Appendix 02).\n* Adequate hematologic and end-organ function, defined by the following laboratory test results:\n\nAbsolute neutrophil count ≥ 1.5 109\u002FL (without growth factor support within 14 d) Platelets ≥ 100 109\u002FL (without transfusion for platelets within 7 d) Hemoglobin ≥ 9 g\u002FdL (without transfusion within 7 d) Creatinine clearance according to CKD-EPI ≥ 30 mL\u002Fmin\u002F1.73 m2 Serum total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert disease for whom a total serum bilirubin ≤ 3 x ULN is acceptable) ASAT and ALAT ≤ 3 x ULN (or up to 5 x ULN in case of liver metastasis or hepatic infiltration)\n\n* Availability of a representative formalin-fixed paraffin-embedded (FFPE) sample of the primary or metastatic tumor tissue (resection or biopsy) with an associated pathology report must be available. This tumor sample must meet the following quality\u002Fquantity control criteria: ≥30 % of tumor cells and a tumor surface area ≥ 5mm2 or biopsiable disease (see next inclusion criteria).\n* Tumor lesion visible by medical imaging and accessible to repeatable percutaneous or endoscopic sampling that permits core needle biopsy without unacceptable risk of a significant procedural complications, and suitable for retrieval of a minimum of 4 cores with a needle minimum diameter :16-gauge.\n\n  * Note 1: Fine needle aspirates, bone biopsies do not satisfy the requirement for tumor tissue.\n  * Note 2: Tumor lesions used for biopsy should not be lesions used as RECIST 1.1 target lesions unless there are no other lesions suitable for biopsy. If a RECIST target lesion is used for biopsy, the lesion must be ≥ 2 cm in longest diameter.\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at the Screening Visit (within 72 hours of first dose of study drugs) and must agree to use highly effective contraceptive measures starting with the Screening Visit through\n\n  * 9 months after the end of the treatment with oxaliplatin\n  * 6 months after the end of the treatment with fluorouracil\n  * 5 months after the end of the treatment with nivolumab or botensilimab or Balstilimab\n  * 6 months for capecitabine\n\n    * Highly effective contraception is defined in Appendix 03.\n\nNote Non-childbearing potential is defined as:\n\n1. ≥ 50 years of age and has not had menses for greater than 1 year.\n2. Amenorrheic for ≥ 2 years without a hysterectomy and bilateral oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation.\n3. Status is post-hysterectomy, bilateral oophorectomy, or tubal ligation.\n\n   * Male patients with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the screening visit through 6 months after the end of the treatment with oxaliplatine or 3 months after the last dose for other study treatments is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.\n   * Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed and 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* Oesogastric cancer eligible to treatment with curative intent\n* Patients previously treated by anti-PD-1, anti-PD-L1, or anti-CTLA-4 or any other immunotherapy\n* Patients with surgery or radiotherapy within less than 4 weeks before C1D1\n* Patients with persistent AE Grade \\>1 related to previous anti-cancer treatment, except alopecia (all grades), laboratory value according to criteria I7.\n* Patients with: hypokalemia, hypomagnesemia, hypocalcemia less than normal\n* Patients with known prolongation QT\u002FQTc interval i.e. QT\u002FQTc interval longer than 450 msec for men and longer than 470 msec for women according to the inclusion ECG.\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.\n\nNote: Asymptomatic patients with treated CNS lesions are eligible, provided that all of the following criteria are met:\n\n* Measurable disease, per RECIST v1.1, must be present outside the CNS.\n* The patient has no history of intracranial hemorrhage or spinal cord hemorrhage.\n* Metastases are limited to the cerebellum or the supratentorial region (i.e., no metastases to the midbrain, pons, medulla, or spinal cord).\n* There is no evidence of interim progression between completion of CNS-directed therapy and initiation of study treatment.\n* The patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, neurosurgical resection within 21 days prior to initiation of study treatment.\n* The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anticonvulsant therapy at a stable dose is permitted. A minimal wash-out period of 10days for corticosteroids is required.\n\n  * Patients with other malignancy unless this malignancy is not expected to interfere with the evaluation of study endpoints (basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, localized prostate cancer), or with no evidence of disease for ≥ 2 years.\n  * Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n  * of ILD or non-infectious pneumonitis requiring glucocorticoids.\n  * History of allogeneic organ transplant.\n  * Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n  * Patient with peripheral sensory neuropathy with functional impairment.\n  * Patients with clinically significant active heart disease or myocardial infarction within 6 months, history of uncontrolled or symptomatic cardiac disease.\n  * Patient with recent (within 7d before C1D1) or concomitant treatment with brivudine.\n  * Patient with complete absence of dihydropyrimidine dehydrogenase (DPD) activity (blood uracil level ≥ 150 ng\u002FmL) or partial deficit in DPD (i.e. blood uracil level between ≥ 16 ng\u002Fml and \\\u003C 150 ng\u002FmL)\n  * Patients with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses (≤ 10 mg daily prednisone equivalent) are permitted in the absence of active autoimmune disease.\n  * Patient with Live vaccines injection within 4 weeks before C1D1. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever and BCG. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines, and are not allowed.\n  * Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years of the start of study treatment (i.e., with use of disease-modifying agents or immunosuppressive drugs).\n  * History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.\n  * Patients with documented:\n* Active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test at screening) unless their HBV is stably controlled on nucleoside analogs (eg entecavir or tenofovir) which will be continued for the duration of the study. Note: Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. HBV DNA test must be performed in these patients prior to C1D1.\n* Active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA, or\n* HIV infection\n\n  * Prior organ or bone marrow transplant.\n  * Pregnant or lactating women.",{"count":291,"type":22},132,[101],"CIME is a multicenter, randomised, comparative, open-label phase III study aiming to compare the survival of patients suffering from MSI-H\u002FdMMR locally advanced or metastatic oeasogastric adenocarcinoma treated by a bi-immunotherapy (experimental arm) versus standard current treatment (FOLFOX\u002FXELOX + nivolumab : standard arm).",[26,295,296,297],"MSI-H","Metastatic Cancer","Advanced Cancer","2026-06-23",{"date":174,"type":39},{"date":301,"type":39},"2025-12-08",{"date":303,"type":22},"2028-05-15",{"name":305,"class":46},"Centre Leon Berard",7,{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":17,"minAge":314,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":317,"conditions":318,"keywords":323,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":330,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":47},"100405330","surgery-in-gastrointestinal-stromal-tumors-gists-for-treatment-tumor-modeling-and-genomic-analysis-100405330","NCT04557969","Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis","Prospective Study of Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis","* INCLUSION CRITERIA:\n* Histological confirmation or clinical presentation suspicious of GIST; histological confirmation will be preferably by review of archival tissue if available, fresh biopsy will not be required if inadequate tissue sample.\n* Age \\>= 6 years\n* ECOG performance status \\\u003C= 2 (Karnofsky or Lansky \\>= 60%)\n* Ability of participant or parent\u002Fguardian to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n\\- Non-modifiable medical comorbidities that would preclude cytoreductive surgery.","6 Years",{"count":316,"type":22},400,"Objective:\n\nTo follow people with GISTs and collect tumor tissue so that it can be studied in the lab.\n\nEligibility:\n\nPeople age 6 and older who have a GIST.\n\nDesign:\n\nParticipants will be screened with a review of their medical records and samples.\n\nParticipants will enroll in 1 other NIH study, and may be asked to enroll in 2 other optional NIH studies.\n\nParticipants will have a medical history and physical exam. Data about how they function in their daily activities will be obtained.\n\nParticipants may speak with a genetic counselor. They may have genetic testing.\n\nParticipants will give blood samples. They may have a cheek swab. For this, small brush will be rubbed against the inside of the cheek.\n\nParticipants may have a computed tomography (CT) scan of the chest, abdomen, and pelvis. Or they may have a CT scan of the chest and magnetic resonance imaging (MRI) of the abdomen and pelvis.\n\nParticipants will be monitored every 6-12 months at the NIH Clinical Center, for up to 10 years before having surgery. If they need surgery, it will be performed at the NIH. Then, they will be monitored every 6-12 months, for up to 5 years after surgery.\n\nIf a participant has surgery, tumor tissue samples and research specimen will be taken.\n\nIf a participant does not need surgery, their participation will end after 10 years. If they have surgery, the 5-year monitoring period will restart after each surgery.",[26,319,320,321,322],"Gastric Neoplasm","Gastrointestinal Stromal Sarcoma","Gastrointestinal Stromal Neoplasm","Gastrointestinal Stromal Tumor (GIST)",[324,325,326,327,328,329],"Tyrosine Kinase Inhibitor (TKI) Therapy","Wild-Type GISTs (WT GISTs)","PDGFRA Mutation","KIT Mutation","SDH Mutation","Natural History",{"date":274,"type":39},{"date":332,"type":39},"2020-12-18",{"date":334,"type":22},"2040-12-30",{"name":336,"class":337},"National Cancer Institute (NCI)","NIH",{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":345,"targetDuration":4,"studyType":57,"phases":347,"briefSummary":350,"conditions":351,"keywords":355,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":47},"100626207","phase-1-18ffpyqcp-pet-imaging-of-fibroblast-activation-protein-in-selected-oncology-indications-100626207","NCT07432633","[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications","A Phase 1\u002F2 Study of [18F]FPyQCP for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications","Inclusion Criteria:\n\n1. Participants provide informed consent and confirm that they are able and willing to comply with all protocol requirements.\n2. Participants must be ≥ 18 years and \\\u003C 80 years of age and competent to give informed consent.\n3. Eastern Cooperative Oncology Group performance status ≤ 2.\n4. Diagnosis of either CRC (confirmed by histopathology), GC (confirmed by histopathology), PDAC (confirmed by cytology or histopathology), ILC (confirmed by histopathology), or EOC (suspected or confirmed by cytology or histopathology).\n5. Women of childbearing potential (WOCBP) should have a negative serum test at screening (Visit 1) and a negative urine pregnancy test at the PET\u002FCT imaging visit (Visit 2) prior to \\[18F\\]FPyQCP administration.\n6. WOCBP, and men who are sexually active with WOCBP, must agree to use a highly effective method(s) of contraception for the duration of the study\n7. Cohort A specific: Participants with stage I-III (see Appendix 3) CRC, GC, PDAC, ILC, or EOC (stage IV disease is allowed in the setting of oligometastatic disease \\[5 or fewer known metastases) as assessed by conventional imaging within 8 weeks of \\[18F\\]FPyQCP administration.\n8. Cohort B specific: Conventional imaging performed within 8 weeks of screening and no later than 24 hours before \\[18F\\]FPyQCP administration and available for upload to the central imaging vendor, including, at a minimum, a contrast-enhanced CT that includes the abdomen and pelvis.\n9. Either:\n\n   1. Treatment-naïve with at least stage IIB disease. Available biopsy sample or scheduled biopsy or surgical resection no later than Day 42.\n   2. Following neoadjuvant therapy (with at least stage IIB disease at initial presentation) with scheduled biopsy or surgical resection no later than Day 42. \\[18F\\]FPyQCP PET\u002FCT imaging should be performed as close to scheduled procedure as clinically feasible.\n   3. Suspected recurrence after definitive therapy\n\nExclusion Criteria:\n\n1. Participants administered any radioisotope within 5 physical half-lives prior to \\[18F\\]FPyQCP administration.\n2. Participants administered any other IMP within 2 weeks or 5 half-lives, whichever is longest, prior to \\[18F\\]FPyQCP administration.\n3. Participants who have recently received any other contrast agent (\\\u003C 24 hours for intravenous agents and \\\u003C 5 days for oral agents) before the day of \\[18F\\]FPyQCP administration.\n4. Participants with a history of severe claustrophobia or panic attacks when in confined spaces.\n5. Known hypersensitivity to \\[18F\\]FPyQCP or any of its constituents.\n6. Participants with any medical condition or other circumstances at screening or in their past medical history that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or study completion.\n7. Known diagnosis of an autoimmune or inflammatory disorder that is expected to confound image interpretation per investigator judgment, excluding disorders directly related to the index cancer (e.g. tumor-associated pancreatitis or biliary stasis for PDAC).\n8. Medical history of abdomino-pelvic or breast irradiation in the last 3 months.\n9. Presence of any current implanted foreign material (e.g. stents, surgical clips) that may confound image interpretation per investigator judgment.\n10. Significant renal or hepatic impairment.\n11. Female participants who are breastfeeding, unless the participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the \\[18F\\]FPyQCP administration.\n12. Cohort A Specific Exclusion Criteria: 12. No prior history of any other cancer, unless treated with curative-intent and disease-free for at least 5 years before Visit 1 (at least 1 year before Visit 1 for basal cell carcinoma, localized squamous cell carcinoma of the skin and in situ carcinoma of cervix).",{"count":346,"type":22},71,[348,349],"PHASE1","PHASE2","This is a multi-center, open-label, single-arm, Phase 1\u002F2 study designed to evaluate the safety, radiation dosimetry, and preliminary diagnostic performance of \\[18F\\]FPyQCP in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).",[263,352,26,353,354],"Epithelial Ovarian Cancer","Invasive Lobular Breast Carcinoma","Pancreatic Ductal Adenocarcinoma",[356,357],"Positron emission tomography","Fibroblast activation protein","2026-06-22",{"date":298,"type":39},{"date":361,"type":39},"2026-02-19",{"date":363,"type":22},"2028-01-31",{"name":365,"class":123},"Blue Earth Diagnostics",{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":57,"phases":376,"briefSummary":377,"conditions":378,"keywords":380,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":390,"locationsCount":47},"100641907","determining-minimal-residual-disease-using-ctdna-deep-sequencing-100641907","NCT07660627","Determining Minimal Residual Disease Using ctDNA Deep Sequencing","Determination of Minimal Residual Disease by Deep ctDNA Sequencing.","CIT-SEQ","Inclusion Criteria:\n\n* Consent to participate in the study\n* Patients with esophageal, gastric, or pancreatic cancer, stage 0-2\n* Patients with locally advanced, potentially operable disease treated with systemic perioperative chemotherapy or chemoradiotherapy\n* Patients with metastatic disease treated with first- to third-line palliative systemic therapy\n\nExclusion Criteria:\n\n* not specified",{"count":375,"type":22},34,[59],"Preoperative neoadjuvant chemotherapy is the standard treatment for locally advanced gastrointestinal tumours. However, not all patients respond to preoperative treatment. Early identification of progression during neoadjuvant chemotherapy or diagnosis of early disease relapse during adjuvant treatment is essential to modify the treatment strategy. The aim of this project is to validate ctDNA as a biomarker of molecular relapse\u002Fprogression of disease.",[379,26,76],"Esophageal Adenocarcinoma",[381,382,383,384],"Minimal residual disease","NGS sequencing","gastrointestinal tumors","Preoperative neoadjuvant chemotherapy","2026-06-19",{"date":274,"type":39},{"date":388,"type":39},"2022-08-22",{"date":180,"type":22},{"name":182,"class":46},{"id":392,"slug":393,"hasResults":12,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":57,"phases":400,"briefSummary":401,"conditions":402,"keywords":404,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":413,"locationsCount":415},"100519056","phase-2-a-study-of-trk-950-when-used-in-combination-with-ramucirumab-and-paclitaxel-in-patients-with-gastric-cancer-100519056","NCT06038578","A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer","A Randomized, Multicenter, Open-Label, Phase 2 Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed metastatic, or locally advanced and unresectable gastric or GEJ adenocarcinoma.\n* The patient is eligible to receive Ramucirumab + Paclitaxel.\n* Documented objective radiographic or clinical disease progression (e.g., any new or worsening malignant effusion documented by ultrasound examination) which may be confirmed by pathologic criteria (histology and\u002For cytology) if appropriate, during or after treatment. The prior treatment must meet one of the following criteria with the following treatment history:\n\n  1. First treatment for metastatic disease or locally advanced disease without experiencing adjuvant \u002F neo-adjuvant treatment, which progressed during treatment or within 4 months after the last dose of treatment\n  2. Adjuvant \u002F neo-adjuvant treatment which progressed more than 6 months after the last dose of treatment and first treatment for metastatic disease or locally advanced disease, which progressed during the treatment or within 4 months after the last dose of treatment\n  3. Adjuvant \u002F neo-adjuvant treatment which progressed during treatment or within 6 months after the last dose of treatment\n  4. Adjuvant \u002F neo-adjuvant treatment which progressed during treatment or within 6 months after the last dose of treatment and first treatment for metastatic disease or locally advanced disease, which progressed during treatment or within 4 months after the last dose of treatment\n* Presence of primary or metastatic disease, measurable per RECIST v1.1 on CT scan.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Life expectancy of at least 3 months.\n* Age ≥ 18 years in the US and Japan, and ≥ 19 years of age in Korea.\n* Signed, written IRB-approved informed consent.\n* Adequate organ function from specimens collected within 14 days prior to Day 1.\n* For men and women of child-producing potential, the use of effective contraceptive methods during the study and for 6 months after the last dose of TRK-950.\n* All patients must sign a pre-screening consent to assess tumor tissue to determine eligibility. Tumor tissue must be evaluable for CAPRIN-1 staining at a CLIA certified laboratory and meet or exceed the cutoff value (30% at ≥ 2+ staining) as defined in the expression level requirements.\n\nExclusion Criteria:\n\n* Prior history of treatment with ramucirumab or paclitaxel.\n* HER2 positive gastric or GEJ adenocarcinoma.\n* Major surgery within 28 days prior to randomization.\n* Baseline corrected QT (QTc) interval of \\> 470 msec for females and \\> 450 msec for males calculated using Fridericia's formula.\n* New York Heart Association (NYHA) Class II - IV symptomatic congestive heart failure, or symptomatic or poorly controlled cardiac arrhythmia.\n* The patient has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 3 months prior to randomization.\n* The patient has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n* Clinically symptomatic venous thromboembolism or current treatment with anti-coagulants. (Patients receiving prophylactic and low-dose anticoagulation therapy are eligible provided that the coagulation parameter defined in the Inclusion Criterion 9 is met.)\n* Uncontrolled arterial hypertension ≥ 150 mmHg (systolic) or ≥ 90 mmHg (diastolic) despite standard medical management.\n* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.\n* Pregnant or nursing women.\n* Treatment with radiation therapy within 2 weeks, or treatment with chemotherapy, immunotherapy, targeted therapy, or investigational therapy within 4 weeks prior to randomization (within 2 weeks for Oral FU (S1 and capecitabine)).\n* The patient has significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 3 months prior to randomization.\n* Clinically significant ascites, paracentesis in the last 3 months, or undergoes regular paracentesis procedures.\n* History of gastrointestinal perforation and\u002For fistulae within 6 months prior to randomization.\n* The patient has a serious or non-healing wound, peptic ulcer, or bone fracture within 28 days prior to randomization.\n* The patient has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (e.g., hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.\n* Known active infection with HIV, hepatitis B or hepatitis C. Patients with a history of hepatitis B or C are allowed if HBV DNA or Hep C RNA are undetectable.\n* The patient is currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Patients who have recently discontinued dosing of study drug are eligible to participate as long as the final dose of study drug was ≥ 28 days from randomization for participation in this study. Patients participating in surveys or observational studies are eligible to participate in this study.",{"count":399,"type":22},146,[349],"This study will assess the efficacy, safety, optimal dose and ADA and NAbs development of TRK-950 at two separate dose levels in combination with ramucirumab and paclitaxel (RAM+PTX) as compared with RAM + PTX treatment alone in participants with gastric or gastro-esophageal junction (GEJ) adenocarcinoma.",[403,26,104],"Gastric Adenocarcinoma",[405,104,406,407],"Gastric Cancer, Adenocarcinoma","TRK-950","CAPRIN-1","2026-06-18",{"date":298,"type":39},{"date":411,"type":39},"2023-10-04",{"date":115,"type":22},{"name":414,"class":123},"Toray Industries, Inc",27,{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":422,"targetDuration":4,"studyType":57,"phases":424,"briefSummary":425,"conditions":426,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":47},"100641343","phase-2-gi-05-the-impact-of-olanzapine-among-patients-receiving-neoadjuvant-chemotherapy-for-gastric-cancer-100641343","NCT07581405","GI-05: The Impact of Olanzapine Among Patients Receiving Neoadjuvant Chemotherapy for Gastric Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years of age at time of consent\n* Eastern Cooperative Oncology Group (ECOG) score of 0-2\n* Histologically confirmed gastric adenocarcinoma, documented by biopsy.\n* Planned to receive neoadjuvant chemotherapy followed by surgical resection, as determined by the treating oncologist.\n* Demonstrates adequate organ function. All screening labs are to be obtained within 30 days prior to registration.\n* Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board informed consent form and HIPAA authorization. If a subject is unable to consent, a Legally Authorized Representative (LAR) may provide consent on their behalf.\n* Women of childbearing potential must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.\n* As determined at the discretion of the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study\n\nExclusion Criteria:\n\n* Active infection requiring systemic therapy\n* Uncontrolled HIV\u002FAIDS or active viral hepatitis\n* Pregnant or nursing\n* Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.\n* Patients with a feeding tube (e.g., gastrostomy or jejunostomy) receive their primary source of nutritional intake via enteral tube feeding at the time of enrollment.\n* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.\n* Other major comorbidity, as determined by the study PI",{"count":423,"type":22},26,[349],"This is a single-center, randomized, open-label clinical trial designed to evaluate the impact of low-dose olanzapine on weight loss, appetite, and nutritional outcomes in patients with gastric cancer receiving neoadjuvant chemotherapy. Eligible patients will be randomized to receive olanzapine 2.5 mg orally once daily (QD) in addition to standard neoadjuvant chemotherapy, beginning prior to initiation of chemotherapy and continuing until surgical resection. Patients will otherwise receive standard-of-care (SOC) oncologic treatment, with no alterations to chemotherapy regimens or surgical management. The study is designed to prospectively assess whether olanzapine improves appetite, mitigates weight loss, and enhances nutritional status and quality of life (QoL) during neoadjuvant therapy. This study will be conducted at the University of Illinois Cancer Center (UICC) as a single-site investigator-initiated trial, with an anticipated accrual of 26 participants over 2 years.",[403,26],"2026-06-16",{"date":408,"type":39},{"date":430,"type":22},"2026-07",{"date":432,"type":22},"2030-07",{"name":434,"class":46},"University of Illinois at Chicago",{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":442,"enrollmentInfo":443,"targetDuration":4,"studyType":57,"phases":445,"briefSummary":446,"conditions":447,"keywords":451,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":464},"100476843","phase-2-study-of-dato-dxd-as-monotherapy-and-in-combination-with-anti-cancer-agents-in-patients-with-advanced-solid-tumours-tropion-pantumor03-100476843","NCT05489211","Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)","A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced\u002FMetastatic Solid Tumours","Key Inclusion Criteria: There are additional substudy requirements not reflected here. This list is based solely on the master CSP\n\n* Male and female, ≥ 18 years\n* Documented advanced or metastatic malignancy\n* Eastern Cooperative Oncology Group performance status of 0 or 1 with no deterioration over the 2 weeks prior to baseline or day of first dosing\n* All participants must provide a tumour sample for tissue-based analysis\n* At least 1 measurable lesion not previously irradiated, except Substudy 3 (Prostate Cancer) which allows participants with non measurable bone metastatic disease\n* Adequate bone marrow reserve and organ function\n* Minimum life expectancy of 12 weeks\n* At the time of screening, contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n* All women of childbearing potential must have a negative serum pregnancy test documented during screening\n* Female participants must be 1 year post-menopausal, surgically sterile, or using 1 highly effective form of birth control. Female participants must not donate, or retrieve for their own use, ova at any time during this study\n* Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile, avoid intercourse, or use a highly effective method of contraception. Male participants must not freeze or donate sperm at any time during this study.\n* Capable of giving signed informed consent\n* Provision of signed and dated written optional genetic research informed consent prior to collection of samples for optional genetic research that supports the Genomic Initiative\n\nKey Exclusion Criteria:\n\n* Any evidence of diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol\n* History of another primary malignancy except for adequately resected basal cell carcinoma or in situ squamous cell carcinoma of the skin, or other solid malignancy treated with curative intent\n* Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved\n* Irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the investigator, for example hearing loss\n* Spinal cord compression or brain metastases unless treated\n* Leptomeningeal carcinomatosis\n* Clinically significant corneal disease\n* Active hepatitis or uncontrolled hepatitis B or C virus infection\n* Uncontrolled infection requiring IV antibiotics, antivirals or antifungals, for example prodromal symptoms\n* Known HIV infection that is not well controlled\n* Known active tuberculosis infection\n* Mean resting corrected QTcF \\> 470 ms\n* In the judgement of the investigator, history of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause TdP\n* In the judgement of the investigator, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives\n* Uncontrolled or significant cardiac diseases\n* History of non-infectious Interstitial lung disease (ILD)\u002Fpneumonitis, including radiation pneumonitis that required steroids\n* Has severe pulmonary function compromise\n* Prior exposure to chloroquine\u002Fhydroxychloroquine without an adequate treatment washout period\n* Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention\n* Prior exposure to anticancer therapies without an adequate treatment washout period prior to enrolment or any concurrent anticancer treatment\n* Palliative radiotherapy with a limited field of radiation within ≤ 2 weeks or to more than 30% of the bone marrow within ≤ 4 weeks before the first dose of study intervention\n* Major surgical procedure or significant traumatic injury within ≤ 3 weeks of the first dose of study intervention or an anticipated need for major surgery during the study\n* Prior treatment with TROP2-directed therapies or other antibody-drug conjugate (ADCs) with deruxtecan payload\n* Herbal or natural products intended as treatment or prophylaxis for any type of cancer that may interfere with the activity of the study intervention\n* Previous treatment in the present study\n* Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 4 weeks prior to first dose of study intervention or concurrent enrolment in another clinical study\n* Severe hypersensitivity to Dato-DXd or any of the excipients, including but not limited to polysorbate 80 or other monoclonal antibodies\n* Involvement in the planning and\u002For conduct of the study\n* Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements\n* Females that are pregnant, breastfeeding, or planning to become pregnant\n* Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of Dato-DXd","130 Years",{"count":444,"type":22},454,[349],"TROPION-PanTumor03 will investigate the safety, tolerability, and anti-tumour activity of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced\u002FMetastatic Solid Tumours.",[68,26,448,75,263,449,450],"Metastatic Castration-resistant Prostate Cancer","Urothelial Cancer","Biliary Tract Cancer",[452,453,454,455,456],"TROPION-PanTumor03","Datopotamab Deruxtecan (Dato-DXd)","Solid Tumours","Antibody-drug conjugate (ADC)","Trophoblast cell surface protein 2 (TROP2)",{"date":458,"type":39},"2026-06-17",{"date":460,"type":39},"2022-09-06",{"date":462,"type":22},"2027-10-01",{"name":122,"class":123},96,{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":442,"enrollmentInfo":472,"targetDuration":4,"studyType":57,"phases":474,"briefSummary":475,"conditions":476,"keywords":477,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":90},"100586941","phase-1-study-for-azd4360-in-participants-with-advanced-solid-tumours-100586941","NCT06921928","Study for AZD4360 in Participants With Advanced Solid Tumours","A Phase I\u002FII Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD4360 in Adult Participants With Advanced Solid Tumours","Inclusion Criteria:\n\n1. Participant must be ≥ 18 at the time of signing the ICF.\n2. Eastern cooperative oncology group performance status of 0-1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.\n3. Minimum life expectancy of 12 weeks in the opinion of the Investigator.\n\n4 Adequate organ and marrow function, as defined by protocol.\n\n5\\. Contraceptive use by men or women should be consistent with local regulations, as defined by protocol.\n\n6\\. Histologically confirmed advanced or metastatic Pancreatic ductal adenocarcinoma (PDAC), Gastric or Gastroesophageal junction cancer (G\u002FGEJC), and Biliary tract cancer (BTC) with documented positive CLDN18.2 expression.\n\n7\\. Participants must have received at least one prior line of systemic therapy in the advanced\u002Fmetastatic disease.\n\n8\\. At least one measurable lesion according to RECIST v1.1.\n\nExclusion Criteria:\n\n1. Human Epidermal Growth Factor Receptor 2 (HER2) positive (3+ by IHC or 2+ by IHC and positive by in situ hybridisation) or indeterminate G\u002FGEJC participants.\n2. Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.\n3. Participants with clinically significant ascites that require drainage.\n4. Central nervous system (CNS) metastases or CNS pathology, as defined by protocol.\n5. With spinal cord compression or with high risk of paralysis.\n6. History of non-infectious interstitial lung disease\u002Fpneumonitis.\n7. Participant has cardiac abnormalities, as defined by protocol.\n8. History of another primary malignancy within 2 years prior to screening.\n9. Known serologic status reflecting active hepatitis B or hepatitis C.\n10. Known HIV infection that is not well controlled.\n11. Active tuberculosis infection.",{"count":473,"type":22},117,[348,349],"The purpose of this study is to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD4360 in adult participants with locally advanced or metastatic solid tumours selected for expression of CLDN18.2.",[26,137,450,354],[26,137,450,354,478,479,480],"Advanced Solid Tumours","AZD4360","Claudin 18.2","2026-06-15",{"date":427,"type":39},{"date":484,"type":39},"2025-04-29",{"date":486,"type":22},"2027-12-16",{"name":122,"class":123},{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":4,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":57,"phases":497,"briefSummary":498,"conditions":499,"keywords":503,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":508,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":515},"100498336","phase-1-bal0891-in-patients-with-advanced-solid-tumors-or-relapsed-or-refractory-acute-myeloid-leukemia-100498336","NCT05768932","BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia","A Phase 1 Study of BAL0891 as Monotherapy and in Combination With Chemotherapy or Tislelizumab in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia","1.1. Inclusion criteria: Substudy 1, 2, 3 and Dose expansion Each patient must meet all the following inclusion criteria.\n\n1. Informed consent signed by the patient prior to any study-related procedure indicating that they understand the purpose of, and procedures required for, the study, and are willing to participate in the study.\n2. Male or female aged ≥18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening.\n3. Patients with incurable advanced\u002Fmetastatic solid tumor disease refractory to or intolerant of existing therapy known to provide clinical benefit for their condition.\n\n   Note: Patients with non-CNS tumors participating during dose escalation may have inactive CNS metastasis, defined as 4 weeks after either brain metastasis resection or radiation, and a) all residual neurological symptoms resolved to grade ≤ 2; b) on stable doses of dexamethasone, if applicable; and c) follow-up imaging shows no new lesions appearing.\n4. Patients enrolled in Dose Expansion only\n\n   • TNBC cohorts i. Must have histologically confirmed breast adenocarcinoma that is unresectable, loco-regional, or metastatic.\n\n   ii. Must have source data documented pathologically confirmed triple negative breast cancer, defined as both of the following.\n   1. Estrogen receptor (ER) and progesterone receptor (PgR) negative: \\\u003C1% of tumor cell nuclei are immunoreactive in the presence of evidence that the sample can express ER or PgR (positive intrinsic controls)\n   2. Human epidermal growth factor receptor 2 (HER2) negative as per American Society of Clinical Oncology\u002FCollege of American Pathologists guidelines\n\n      * IHC 0 or 1 fluorescence in situ hybridization (FISH) negative (or equivalent negative test)\n      * Patients with IHC 2 must have a negative by FISH (or equivalent negative test) iii. Patients with a history of different breast cancer phenotypes (i.e., ER\u002FPgR\u002FHER2 Positive) must obtain pathological confirmation of triple-negative disease in at least one of the current sites of metastasis.\n\n   iv. Must have progression on or after therapy containing anthracycline and\u002For a taxane. Subjects must have received anthracycline and\u002For a taxane based regimen or other chemotherapy \u002F targeted therapy regimen if anthracycline or taxane was contraindicated or another available approved targeted agent was contraindicated. At time of enrolment, patients must have progressed on, be intolerant of, or be ineligible for, all available standard of care therapies with proven benefit.\n\n   • GC cohort i. Must have a histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.\n\n   ii. Must have progression on or after therapy containing platinum\u002Ffluoropyrimidine. Subjects must have received platinum-based chemotherapy or other chemotherapy regimen if platinum-based chemotherapy was contraindicated or another available approved targeted agent unless the targeted agent was contraindicated. At time of enrolment, patients must have progressed on, be intolerant of, or be ineligible for, all available standard of care therapies with proven benefit.\n\n   iii. Documentation of HER2\u002Fneu status. Patients who are HER2\u002Fneu-positive must be treated with a HER2\u002Fneu inhibitor, and subjects should have progressed on or be intolerant to the targeted therapy or subjects must have received other chemotherapy regimen if HER2\u002Fneu inhibitor was contraindicated or another available approved targeted agent unless the targeted agent was contraindicated. At time of enrolment, patients must have progressed on, be intolerant of, or be ineligible for, all available standard of care therapies with proven benefit.\n\n   iv. Subjects must\u002Fshould have received no more than 3 lines of prior therapy for the advanced disease (if a subject progressed within 6 months of completing adjuvant therapy, this would count as a prior line of therapy).\n5. For patients enrolled in Substudy 3 or cohort 3 and 4, if a taxane (i.e., paclitaxel or docetaxel) was administered as part of the previous regimen, PD must have occurred \\> 12 months from the end of the previous treatment. (Patients who received a taxane in previous treatments without reaching PD may enroll without the 12-month waiting period.)\n6. Patients enrolled in Dose Expansion only, patient must have undergone a minimum of 1 prior systemic regimen for advanced or metastatic disease. (Korea only, patients must have received the second line standard of care treatment as per the regulations of the respective country. Patients who are unsuitable to receive the standard of care second line treatment will be eligible for enrollment)\n7. Eastern Cooperative Oncology Group performance status (ECOG PS) 0or-1\n8. For patients enrolled from DL1.4 of Substudy 1 onwards and for all patients in Substudies 2 and 3 and all four dose expansion cohorts, measurable tumor disease per Response Evaluation Criteria in Solid Tumors 1.1 criteria (RECIST 1.1), i.e., a minimum of one target lesion.\n9. Adequate organ functions as indicated by the following Screening visit local laboratory values:\n\n   1. Hemoglobin ≥ 9 g\u002FdL (criterion must be met without erythropoietin dependency and without packed red blood cell transfusion within the last 4 weeks)\n   2. ANC ≥ 2.0 × 109\u002FL; criterion must be met without growth factor (e.g., G-CSF, GM CSF, etc.) administration within the last 2 weeks\n   3. Platelets ≥ 100 × 109\u002FL\n   4. Total bilirubin ≤ 1.5 × ULN\n   5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) baseline levels ≤ 1.5 × ULN, with the option for AST\u002FALT ≤ 3.0 × ULN, or ≤ 5.0 × ULN for patients with liver metastasis, upon accumulating evidence for the absence of liver toxicity in biologically active DLs\n   6. Albumin ≥ 2.8 g\u002FdL\n   7. CLCR ≥ 50 mL\u002Fmin (as calculated by the Cockcroft-Gault formula), or eGFR ≥ 50 mL\u002Fmin\u002F1.73 m² (MDRD equation or CKD-EPI equation)\n   8. For women of childbearing potential, negative serum human chorionic gonadotropin (hCG)\n10. Men\u002Fwomen of child-producing\u002Fbearing potential must agree to: avoid impregnating a partner or becoming pregnant, respectively, during the study, and for at least 6 months after the last dose of either investigational drug, and comply with the contraception requirements.\n\n1.2. Inclusion criteria: Substudy 4 Each patient must meet all the following inclusion criteria.\n\n1. Informed consent signed by the patient prior to any study-related procedure indicating that they understand the purpose of, and procedures required for, the study, and are willing to participate in the study.\n2. Male or female aged ≥18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening.\n3. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.\n4. Estimated life expectancy of at least 8 weeks\n5. AML either de novo or secondary as any subtype diagnosed according to the WHO 2022 classification system \\[except acute promyelocytic leukemia (APL)\\] who either:\n\n   Relapse\u002Frefractory (R\u002FR) acute myeloid leukemia (AML) defined as those who have also failed or are not appropriate for any approved standard-of-care (SOC) therapies, or hematopoietic stem cell transplant (HSCT) with reappearance of ≥ 5% blasts in the bone marrow.\n6. Relapsed AML is defined as having 5% or more leukemic blasts in the bone marrow, reappearance of leukemic blasts in peripheral blood (in at least two peripheral blood samples taken at least one week apart), or the development of new extramedullary disease.\n7. WBC, peripheral blood leukocyte count≤ 25,000\u002FµL and blast count ≤ 25,000\u002FµL prior to initiation of therapy\n\n   1. Hydroxyurea is allowed during screening and prior to day 1 of study treatment to keep the blast count ≤25,000\u002FµL; hydroxyurea is to be ceased 24 hours prior to study therapy.\n   2. Hydroxyurea may be used for up to 28 days in the initial treatment cycle if needed, to keep the white blood cell (WBC) count ≤25,000\u002FµL. However, no other anti-leukemic treatments, apart from the study drug, are allowed during this period.\n   3. Leukapheresis is allowed to maintain blast count ≤25,000\u002FµL\n8. Adequate organ functions as indicated by the following Screening visit local laboratory values:\n\n   1. CLCR ≥ 60 mL\u002Fmin (as calculated by the Cockcroft-Gault formula), or eGFR ≥ 60 mL\u002Fmin\u002F1.73 m² (MDRD equation or CKD-EPI equation)\n   2. Total bilirubin ≤ 1.5 × ULN (unless considered due to leukemic organ involvement), or, Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN\n   3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) baseline levels ≤ 3.0 × ULN\n   4. Albumin ≥ 2.5 g\u002FdL\n   5. International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n   6. Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n9. Men\u002Fwomen of child-producing\u002Fbearing potential must agree to: avoid impregnating a partner or becoming pregnant, respectively, during the study, and for at least 6 months after the last dose of either investigational drug, and comply with the contraception requirements.",{"count":496,"type":22},260,[348],"This study is a multiple cohort, multicenter, open-label Phase 1 study with dose-escalation substudies investigating intravenous (IV) BAL0891 as monotherapy, and in combination with tislelizumab or paclitaxel, to determine the safety and tolerability of increasing doses of BAL0891 in patients with advanced solid tumors or relapsed or refractory acute myeloid leukemia. An adaptive model-based design will be used to guide the dose escalation. Subject assignment to Substudy 1, 2, 3 and 4 will be finalized following approval from the investigator and sponsor.\n\nThe dose-expansion stage will be conducted with the RP2D to further evaluate the preliminary anti-tumor activity, safety, and tolerability in metastatic TNBC and GC.",[500,501,26,502],"Advanced Solid Tumor","TNBC - Triple-Negative Breast Cancer","Leukemia Acute Myeloid Leukemia (AML)",[504,505,506,507],"carcinoma","paclitaxel","BAL0891","tislelizumab",{"date":481,"type":39},{"date":510,"type":39},"2022-12-14",{"date":512,"type":22},"2026-12-24",{"name":514,"class":123},"SillaJen, Inc.",17,{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":57,"phases":525,"briefSummary":526,"conditions":527,"keywords":528,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":551},"100476404","phase-1-kk-lc-1-tcr-t-cell-therapy-for-gastric-breast-cervical-and-lung-cancer-100476404","NCT05483491","KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer","T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung, and Other KK-LC-1 Positive Cancers","Inclusion Criteria: Subjects must meet all the following criteria to participate in this study.\n\n1. Signed, written informed consent obtained prior to any study procedures.\n2. Age ≥ 18 years at the time of informed consent.\n3. Metastatic solid tumor with ≥ 10% of tumor cells positive for KK-LC-1 by IHC assay. Due to the low frequency of KK-LC-1 expression in most cancers, screening will focus on gastric, NSCLC, TNBC, and cervix cancers. The IHC test will be performed by the Rutgers Cancer Institute, Department of Biorepository Services.\n4. HLA-A\\*01:01 allele by HLA haplotype test.\n5. Measurable disease per RECIST Criteria Version 1.1 at time of enrollment.\n6. Prior treatment with cancer type-specific standard of care systemic cancer therapy is required. Standard treatment options must be considered and declined. Documentation of rationale is required if a subject is deemed unsuitable for standard therapy.\n7. Subjects with ≤ 3 brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment. Patients with surgically resected brain metastases are eligible.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.\n9. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy test is not required for women who have had a bilateral oophorectomy or hysterectomy.\n10. Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal\u002Fbarrier method of birth control, abstinence, tubal ligation, or vasectomy) prior to study entry and for 12 months after treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n11. Participants must have organ and marrow function as defined below:\n\n    1. Leukocytes \\> 3,000\u002FmcL\n    2. Absolute neutrophil count \\> 1,500\u002FmcL\n    3. Platelets \\> 100,000\u002FmcL\n    4. Hemoglobin \\> 9.0 g\u002FdL\n    5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin \\\u003C 3.0 mg\u002FdL.\n    6. Serum AST (SGOT)\u002FALT (SGPT) \\\u003C 2.5 x ULN\n    7. Calculated creatinine clearance (CrCl) \\> 50 mL\u002Fmin\u002F1.73 m² for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).\n    8. INR or aPTT ≤ 1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or PTT within therapeutic range and no history of severe hemorrhage.\n12. Serology:\n\n    * HIV antibody negative\n    * Hepatitis B antigen negative\n    * Hepatitis C antibody negative or HCV RNA negative (i.e., no current HCV infection)\n13. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the KK-LC-1 TCR-T cells. Adverse events from prior therapy must have resolved to ≤ grade 1 according to CTCAE Version 5.0 or have demonstrated clinical stability and meet the eligibility criteria for the protocol.\n14. Participants must agree to participate in Rutgers protocol 192103 (Pro2021002307) for gene therapy long term follow up and in Rutgers protocol 192002 (Pro2021000281) or NIH protocol 16C0061 (Rutgers 192202) for biospecimen collection study.\n\nNote: Patients may have undergone minor surgical procedures within the past three weeks, as long as all toxicities have recovered to Grade 1 or less.\n\nExclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation in this study:\n\n1. Current treatment with another investigational agent.\n2. History of severe allergic reactions to compounds of similar chemical or biologic composition to agents used in study.\n3. History of coronary revascularization or ischemic symptoms unless patient has a normal cardiac stress test.\n4. Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations:\n\n   1. Clinically significant atrial and\u002For ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or\n   2. Age greater than or equal to 50 years old\n5. Participants with baseline screening pulse oxygen level of less than or equal to 92% on room air will not be eligible. If the underlying cause of hypoxia improves, then they may be reevaluated.\n6. Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations at the time of treatment that would limit compliance with study requirements.\n7. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with KK-LC-1 TCR-T cells, breastfeeding should be discontinued if the mother is treated with KK-LC-1 TCR cells. The potential risks may also apply to other agents used in this study.\n8. Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment.\n9. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications).\n10. Subjects with HLA-A\\*01:01 damaging mutation or allele loss or other molecular resistance detected by clinical or research genomic profiling will not be eligible.\n11. Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not eligible. Prior history of potentially severe autoimmune diseases without a current, active diagnosis is not exclusionary. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible.\n12. Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to:\n\n    1. Carcinoma in situ\n    2. Cutaneous skin cancers requiring only local excision\n    3. Low grade non-muscle invasive bladder cancer\n    4. Low grade prostate cancer Participants with prior or concurrent malignancy that do not meet the above criteria are excluded.\n13. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible.\n14. Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.",{"count":524,"type":22},30,[348],"This is a phase I clinical trial to determine the maximum tolerated dose (MTD) of KK-LC-1 TCR-T cells for the treatment of metastatic cancers that express KK-LC-1. Participants will receive a conditioning regimen, KK-LC-1 TCR-T cells, and aldesleukin. The safety profile and clinical response to treatment will be determined.",[26,65,66,73],[529,530,531,532,533,534,535,536,537,538,539,540,541],"CAR-T","immunotherapy","TIL","stomach cancer","lung cancer","breast cancer","triple negative","cervical cancer","cell therapy","gene therapy","tumor infiltrating lymphocytes","T cells","immune","2026-06-10",{"date":544,"type":39},"2026-06-12",{"date":546,"type":39},"2022-09-26",{"date":548,"type":22},"2028-12-31",{"name":550,"class":46},"Christian Hinrichs",2,{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":558,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":442,"enrollmentInfo":560,"targetDuration":4,"studyType":57,"phases":562,"briefSummary":563,"conditions":564,"keywords":565,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":573,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":579},"100391639","phase-2-ph1b2-study-of-the-safety-and-efficacy-of-t-dxd-combinations-in-advanced-her2-expressing-gastric-cancer-destiny-gastric03-100391639","NCT04379596","Ph1b\u002F2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)","A Phase 1b\u002F2 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants With HER2-expressing Gastric Cancer (DESTINY-Gastric-03)","DG-03","Inclusion criteria:\n\n1. Male and female participants must be at least 18 years of age. Other age restrictions may apply as per local regulations\n2. Disease Characteristics:\n\n   1. Locally advanced, unresectable, or metastatic disease based on most recent imaging\n   2. For Part 1, 2, 3a, 4a pathologically documented adenocarcinoma of the stomach\u002FGEJ\u002Fesophagus, HER2-positive (IHC 3+ or IHC 2+\u002FISH+) based on local tissue testing results\n   3. For Part 3b,4b and Part 5, pathologically documented adenocarcinoma of the stomach\u002FGEJ\u002Fesophagus, HER2-low (IHC 2+\u002FISH-negative or IHC 1+) based on local tissue testing results\n3. For Part 1, progression on or after at least one prior trastuzumabcontaining regimen For Part 2, Part 3, Part 4 and Part 5, previously untreated for unresectable or metastatic adenocarcinoma of the stomach\u002FGEJ\u002F esophagus with with HER2-positive (Part 2 and Part 3 \\[Arm 3A\\] and Part 4 \\[Arm 4A\\]) or HER2-low (Part 3 \\[Arm 3B\\], Part 4 \\[Arm 4B\\] and Part 5)) status\n4. Has measurable target disease assessed by the Investigator based on RECIST version 1.1\n5. Has protocol defined adequate bone marrow and organ function including cardiac, renal and hepatic function\n6. If of reproductive potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study.\n\nExclusion criteria:\n\n1. Part 1 to 4: History of active primary immunodeficiency, known HIV, active chronic, or past hepatitis B infection, or hepatitis C infection. Part 5: evidence of active, uncontroled HIV, HBV or HCV infection.\n2. Uncontrolled intercurrent illness.\n3. History of non-infectious pneumonitis\u002FILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening.\n4. Lung-specific intercurrent clinically significant severe illnesses.\n5. Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.\n6. Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).\n7. Has spinal cord compression or clinically active central nervous system metastases.",{"count":561,"type":22},450,[349],"DESTINY-Gastric03 will investigate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of trastuzumab deruxtecan (T-DXd) alone or in combination with chemotherapy and\u002For immunotherapy in HER2-expressing advanced\u002Fmetastatic gastric\u002Fgastroesophageal junction (GEJ) and esophageal adenocarcinoma patients.\n\nStudy hypotheses: Combination of T-DXd with cytotoxic chemotherapy and\u002For immunotherapy administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and preliminary anti-tumor efficacy so as to permit further clinical testing. T-DXd in combination with cytotoxic chemotherapy or immune checkpoint inhibitor administered to HER2-expressing gastric, GEJ and esophageal cancer patients who have not received prior treatment for advanced\u002Fmetastatic disease will show preliminary evidence of anti-tumour activity and the potential to become a therapeutic option for this patient population.",[26],[26,69,566,567,568,569,570,142,571,572],"Carcinoma","HER2","Trastuzumab","Deruxtecan","T-DXd","Gastroesophageal Cancer","Adenocarcinoma",{"date":277,"type":39},{"date":575,"type":39},"2020-06-03",{"date":577,"type":22},"2027-06-01",{"name":122,"class":123},100,{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":4,"eligibilityCriteria":586,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":57,"phases":589,"briefSummary":590,"conditions":591,"keywords":594,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":605,"completionDateStruct":606,"leadSponsor":608,"locationsCount":4},"100643245","prehabilitation-in-high-risk-oncologic-surgery-100643245","NCT07638410","Prehabilitation in High-risk Oncologic Surgery","SURG-236: Prehabilitation in High-risk Oncologic Surgery: A Prospective Cohort Study","Inclusion Criteria:\n\n* Evidence of probable or confirmed primary or recurrent malignant neoplasm of any stage\n* Planned to undergo neoadjuvant chemotherapy or chemoradiation\n* Eligible surgical candidate for one of the following procedures: pancreatectomy, gastrectomy, esophagectomy, cystectomy, low anterior resection, abdominoperineal resection, or cytoreductive surgery with heated intraperitoneal chemotherapy\n* Age greater than 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Ability to understand and willingness to sign a written informed consent form and Health Insurance Portability and Accountability Act (HIPAA) authorization document\n\nExclusion Criteria:\n\n* Unable to complete study requirements, such as attending a minimum of two visits for each specialty referral. This will be assessed at the final preoperative visit, at which time the participant may be discontinued from the study and replaced. Participants will not be excluded due to lack of insurance coverage for health psychology visits.\n* Does not proceed to surgery at an affiliated institution\n* Pregnant or breastfeeding",{"count":588,"type":22},180,[59],"The goal of this clinical study is to learn whether a prehabilitation program can improve recovery after major abdominal surgery in adults with cancer who are receiving treatment before surgery. Prehabilitation is supportive care given before surgery to help patients prepare physically, nutritionally, and emotionally.\n\nThe main questions this study aims to answer are:\n\n1. Does prehabilitation reduce the number of participants who die or have serious complications within 30 days after surgery?\n2. Does prehabilitation improve physical strength and fitness, nutritional status, emotional well-being, and quality of life before surgery?\n3. Does prehabilitation affect the length of the hospital stay after surgery, the time it takes to start additional cancer treatment after surgery, or the ability to complete recommended additional treatment?\n\nParticipants will take part in a prehabilitation program during their treatment period before surgery. The program includes visits with physical therapy, nutrition, and health psychology. Participants will meet with each specialty at least twice before surgery. They will also complete questionnaires and tests that measure physical function, diet and weight, emotional well-being, and quality of life. After surgery, information about recovery and additional cancer treatment will be collected from medical records for up to 120 days.\n\nResearchers will compare the outcomes of participants who receive the prehabilitation program with outcomes from similar patients who previously received care at Fox Chase Cancer Center but did not participate in this study.",[76,592,26,69,207,75,593],"Colo-rectal Cancer","Abdominal Surgery Complications",[595,596,597,598,599,600,601,602],"Prehabilitation","Preoperative Rehabilitation","Multimodal Prehabilitation","Major Abdominal Surgery","Oncologic Surgery","Neoadjuvant Therapy","Postoperative Complications","Cancer Surgery","2026-06-09",{"date":277,"type":39},{"date":481,"type":22},{"date":607,"type":22},"2030-03-15",{"name":609,"class":46},"Fox Chase Cancer Center",{"id":611,"slug":612,"hasResults":12,"nctId":613,"briefTitle":614,"officialTitle":615,"acronym":4,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":617,"targetDuration":4,"studyType":57,"phases":619,"briefSummary":620,"conditions":621,"keywords":631,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":646,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":651,"locationsCount":653},"100632708","phase-1-dose-determining-study-of-exs74539-rec-4539-in-participants-with-select-solid-tumors-100632708","NCT07517198","Dose Determining Study of EXS74539 (REC-4539) in Participants With Select Solid Tumors","A Phase 1, Multicenter, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability, and Efficacy of EXS74539 as Monotherapy in Participants With Select Solid Tumors","Key Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Histologically confirmed diagnosis of the following solid tumors:\n\n  * SCLC\n  * High grade neuroendocrine or small cell carcinomas of non-lung origin\n  * Non-small cell lung cancer \\[NSCLC\\]\n  * Prostate cancer\n  * Ovarian cancer\n  * Renal carcinoma \\[clear and non-clear cell\\]\n  * Head and neck squamous cell carcinoma\n  * Hepatic cancer\n  * Gastric cancer\n  * Triple-negative breast cancer \\[TNBC\\]\n* Participant disease should have progressed, relapsed or the participants should have been intolerant to at least one prior standard systemic therapy for their respective underlying malignancy.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n\nKey Exclusion Criteria:\n\n* Any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's safety or ability to participate in the study.\n* Symptomatic brain metastases, leptomeningeal metastases, or spinal cord compression due to disease. Participants with brain metastases must be clinically stable and off corticosteroids and anticonvulsants for ≥1 month prior to study treatment and not require any specific intervention for brain metastases.\n* Active and clinically significant infection requiring systemic antibacterial, antiviral, or antifungal therapy \\\u003C7 days of the first scheduled dose of the study treatment.\n* Significant cardiac abnormalities.\n* Major surgery within 28 days prior to the start of study treatment.\n\nNote: Other protocol-defined inclusion and exclusion criteria may apply.",{"count":618,"type":22},40,[348],"The primary purpose of this study is to determine the safety, tolerability, and maximum tolerated dose (MTD) of EXS74539 (REC-4539) in participants with select solid tumors.",[622,623,624,625,626,77,75,627,628,629,26,630],"Solid Tumor","Small Cell Lung Cancer (SCLC)","High Grade Neuroendocrine Cancer","Small Cell Carcinomas of Non-lung Origin","Non-small Cell Lung Cancer (NSCLC)","Renal Carcinoma (Clear and Non-clear Cell)","Head and Neck Squamous Cell Carcinoma (HNSCC)","Hepatic Cancer","Triple-negative Breast Cancer (TNBC)",[632,623,633,634,635,636,637,638,639,640,641,642,643,644,645],"Solid Tumors","High grade neuroendocrine cancer","Small cell carcinomas of non-lung origin","Non-small cell lung cancer (NSCLC)","Prostate cancer","Ovarian cancer","Renal carcinoma (clear and non-clear cell)","Head and neck squamous cell carcinoma (HNSCC)","Hepatic cancer","Gastric cancer","Triple-negative breast cancer (TNBC)","LSD1 inhibitor","EXS74539","REC-4539",{"date":542,"type":39},{"date":648,"type":39},"2026-04-13",{"date":650,"type":22},"2029-03",{"name":652,"class":123},"Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.",3,{"id":655,"slug":656,"hasResults":12,"nctId":657,"briefTitle":658,"officialTitle":659,"acronym":4,"eligibilityCriteria":660,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":661,"enrollmentInfo":662,"targetDuration":4,"studyType":57,"phases":663,"briefSummary":664,"conditions":665,"keywords":666,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":669,"lastUpdatePostDateStruct":670,"startDateStruct":671,"completionDateStruct":673,"leadSponsor":675,"locationsCount":677},"100525939","clinical-study-of-taurine-combined-with-neoadjuvant-chemo-immunotherapy-for-treatment-of-locally-advanced-gastric-cancer-100525939","NCT06128252","Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer","A Prospective, Multicentre, Double-blind Randomized Controlled Clinical Study of the Efficacy and Safety of Taurine Combined With Serplulimab and Chemotherapy Versus Serplulimab Combined With Chemotherapy for Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Age 18-75 years old, no gender limitation;\n2. Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma with cTNM stage II\u002FIII，T≥3, N ≥0, M=0；\n3. Expected survival of ≥ 3 months;\n4. The tumor specimens were PD-L1 positive (CPS ≥ 1)；\n5. There is a measurable lesion with the possibility of radical R0 resection after evaluation by doctors；\n6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n7. Patients informed about the purpose and course of the study and provided a written consent to participate.\n\nExclusion Criteria:\n\n1. Use of taurine agent within 1 month prior to the first dose of study treatment and throughout the study;\n2. Patients with positive HER-2；\n3. Patients with gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia;\n4. Patients with severe heart, lung, liver, kidney, endocrine, hematopoietic system or psychiatric diseases were considered not suitable for the study group;\n5. Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS) or autoimmune disease or immunosuppressant use；\n6. There are patients who may increase the risk of participating in the study and study medication, or other severe, acute and chronic diseases, and are not suitable for participating in the clinical study according to the judgment of the investigator.","75 Years",{"count":464,"type":22},[59],"This project aims to evaluate the efficacy and safety of oral taurine supplementation combined with PD-1 inhibitor (serplulimab) and chemotherapy in inducing systemic CD8+ T cell responses and achieving improved gastric cancer patient outcomes than with serplulimab and chemotherapy alone.",[26],[667,668],"Taurine","neoadjuvant immunotherapy and chemotherapy","2026-06-08",{"date":603,"type":39},{"date":672,"type":39},"2024-09-01",{"date":674,"type":22},"2027-06-30",{"name":676,"class":46},"Tang-Du Hospital",15,{"id":679,"slug":680,"hasResults":12,"nctId":681,"briefTitle":682,"officialTitle":683,"acronym":4,"eligibilityCriteria":684,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":685,"targetDuration":4,"studyType":57,"phases":687,"briefSummary":688,"conditions":689,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":669,"lastUpdatePostDateStruct":691,"startDateStruct":692,"completionDateStruct":694,"leadSponsor":696,"locationsCount":47},"100370724","phase-2-phase-ii-study-of-the-effects-of-laparoscopic-hyperthermic-intraperitoneal-chemotherapy-hipec-in-patients-with-advanced-gastric-cancer-100370724","NCT04107077","Phase II Study of the Effects of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Gastric Cancer","A Phase IIa Study of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and PD-L1 Expression in Gastric Cancer With Peritoneal Metastases","Inclusion Criteria:\n\n* Patients with histologically confirmed GC\u002FPM only and\u002For positive peritoneal cytology, who have completed prior systemic chemotherapy for a minimum of 2 to 4 months duration.\n* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of HIPEC for GC\u002FPM in patients under 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).\n* Patients must have adequate organ and marrow function as defined below:\n\n  * leukocytes ≥3,000\u002FmcL\n  * absolute neutrophil count ≥1,500\u002FmcL\n  * platelets ≥100,000\u002FmcL\n  * total bilirubin ≤ institutional upper limit of normal (ULN)\n  * AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN\n  * creatinine ≤ institutional ULN OR\n  * glomerular filtration rate (GFR) ≥50 mL\u002Fmin\u002F1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\u002F1.73 m2 (see Appendix B).\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* 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.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n* Expected survival greater than 3 months.\n* Because cisplatin and Mitomycin C are pregnancy category D and potentially teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of the study.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients with coexistence of another untreated malignant neoplasm other than basal cell carcinoma of the skin within the last five years.\n* Sites of metastases other than loco-regional lymph nodes and peritoneum (ex. Visceral metastases such as liver, lungs, bone, brain).\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia.\n* Patients who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin and Mitomycin C.\n* Patients with uncontrolled intercurrent illness.\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because cisplatin and Mitomycin C are class D agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cisplatin and Mitomycin C, breastfeeding should be discontinued if the mother is treated with cisplatin and Mitomycin C.",{"count":686,"type":22},21,[349],"To assess if PD-L1 expression can be upregulated in peritoneal metastases from gastric cancer after the administration of HIPEC with greater frequency compared to systemic chemotherapy alone",[26,690],"Peritoneal Carcinomatosis",{"date":277,"type":39},{"date":693,"type":39},"2025-09-09",{"date":695,"type":22},"2030-06-01",{"name":697,"class":46},"University of Chicago",{"id":699,"slug":700,"hasResults":12,"nctId":701,"briefTitle":702,"officialTitle":703,"acronym":4,"eligibilityCriteria":704,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":705,"targetDuration":4,"studyType":57,"phases":707,"briefSummary":708,"conditions":709,"keywords":713,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":717,"lastUpdatePostDateStruct":718,"startDateStruct":719,"completionDateStruct":721,"leadSponsor":723,"locationsCount":725},"100569561","phase-2-a-phase-2-study-of-zanidatamab-in-patients-with-her2-expressing-tumors-100569561","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.",{"count":706,"type":22},200,[349],"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.",[65,26,69,571,263,68,710,75,711,220,76,712],"Non-small Cell Lung Cancer","Urothelial Carcinoma","HER-2 Protein Overexpression",[714,715,716],"JZP598","ZW25","HER2 IHC 3+ Overexpression Solid Tumors","2026-06-05",{"date":603,"type":39},{"date":720,"type":39},"2025-01-14",{"date":722,"type":22},"2027-12-31",{"name":724,"class":123},"Jazz Pharmaceuticals",28,{"id":727,"slug":728,"hasResults":12,"nctId":729,"briefTitle":730,"officialTitle":731,"acronym":4,"eligibilityCriteria":732,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":733,"targetDuration":4,"studyType":57,"phases":734,"briefSummary":735,"conditions":736,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":717,"lastUpdatePostDateStruct":743,"startDateStruct":744,"completionDateStruct":746,"leadSponsor":748,"locationsCount":750},"100483897","phase-1-a-study-to-evaluate-the-safety-pharmacokinetics-and-activity-of-enzelkitug-as-a-single-agent-and-in-combination-with-checkpoint-inhibitor-in-participants-with-locally-advanced-or-metastatic-solid-tumors-100483897","NCT05581004","A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors","A Phase Ia\u002FIb, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Life expectancy of at least 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)\n* Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy\n* Tumor specimen availability\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding or intention of becoming pregnant during the study or within 4 months after the final dose of enzelkitug, or 4 months after the final dose of pembrolizumab, or 5 months after the final dose of atezolizumab\n* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and\u002For radiotherapy, within 3 weeks prior to initiation of study treatment\n* Active hepatitis B (HBV) or hepatitis C (HCV) or tuberculosis\n* Positive test for human immunodeficiency virus (HIV) infection\n* Acute or chronic active Epstein-Barr virus (EBV) infection at screening\n* Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first enzelkitug infusion\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases\n* Active or history of autoimmune disease\n* Prior allogeneic stem cell or organ transplantation",{"count":561,"type":22},[348],"This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of enzelkitug when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.",[737,738,739,226,740,69,26,66,263,711,741,742],"Locally Advanced or Metastatic Solid Tumors","NSCLC","HNSCC","TNBC","Clear Cell RCC","HCC",{"date":603,"type":39},{"date":745,"type":39},"2022-10-20",{"date":747,"type":22},"2028-07-31",{"name":749,"class":123},"Genentech, Inc.",41,{"id":752,"slug":753,"hasResults":12,"nctId":754,"briefTitle":755,"officialTitle":756,"acronym":4,"eligibilityCriteria":757,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":661,"enrollmentInfo":758,"targetDuration":4,"studyType":57,"phases":760,"briefSummary":761,"conditions":762,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":763,"lastUpdatePostDateStruct":764,"startDateStruct":766,"completionDateStruct":768,"leadSponsor":770,"locationsCount":47},"100632781","phase-3-a-study-comparing-bl-m05d1-with-the-investigators-choice-of-treatment-regimen-in-patients-with-claudin-cldn182-positive-advanced-gastric-cancer-or-gastroesophageal-junction-adenocarcinoma-gcgejc-who-have-received-prior-first-line-treatment-100632781","NCT07518147","A Study Comparing BL-M05D1 With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN)18.2-Positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC\u002FGEJC) Who Have Received Prior First-Line Treatment","A Randomized Controlled Phase III Clinical Study Comparing BL-M05D1 for Injection With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN) 18.2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC\u002FGEJC) Who Have Received Prior First-line Treatment","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restrictions;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Pathologically confirmed locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma;\n6. Patients who have failed prior first-line standard therapy must have evidence of radiographic clear progression;\n7. Ability to provide archived or fresh tumor tissue;\n8. Must have at least one measurable lesion as defined by RECIST v1.1;\n9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n10. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n11. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;\n12. Organ function levels must meet the requirements;\n13. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × upper limit of normal (ULN);\n14. Urine protein ≤2+ or \\\u003C1000 mg\u002F24h;\n15. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with serum pregnancy test negative, and must be non-lactating; all enrolled patients (regardless of male or female) must take adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after treatment completion.\n\nExclusion Criteria:\n\n1. Prior anti-tumor treatment;\n2. Positive HER2 expression in tumor tissue;\n3. History of severe cardiovascular or cerebrovascular disease;\n4. Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;\n5. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening;\n6. Active autoimmune diseases and inflammatory diseases;\n7. Diagnosis of another malignancy within 3 years prior to the first dose;\n8. Hypertension poorly controlled by two antihypertensive medications;\n9. History of interstitial lung disease (ILD) requiring hormone therapy, etc.;\n10. Concurrent pulmonary disease resulting in clinically severe respiratory impairment;\n11. Infection requiring clinical intervention within 2 weeks prior to randomization;\n12. Patients with poorly controlled blood glucose levels;\n13. Patients with active central nervous system metastases;\n14. Patients with large serous cavity effusions, symptomatic serous cavity effusions, or poorly controlled serous cavity effusions;\n15. Imaging findings indicating tumor invasion or encasement of major blood vessels such as those in the chest, neck, or pharynx;\n16. History of allergic reactions to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of BL-M05D1;\n17. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;\n18. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n19. Active infection requiring systemic treatment;\n20. Pregnant or breastfeeding women;\n21. Esophageal or gastric varices requiring intervention within the past three months, etc.;\n22. History of intestinal obstruction, inflammatory bowel disease, or extensive bowel resection, etc.;\n23. Presence of other serious physical or laboratory abnormalities, or poor compliance, which may increase the risk of participating in the study, interfere with study results, or make the patient unsuitable for participation in the study as judged by the investigator.",{"count":759,"type":22},438,[101],"This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M05D1 in patients with Claudin (CLDN) 18.2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC\u002FGEJC) who have received prior first-line treatment.",[26,104],"2026-06-03",{"date":765,"type":39},"2026-06-04",{"date":767,"type":39},"2026-05-15",{"date":769,"type":22},"2029-12",{"name":771,"class":123},"Sichuan Baili Pharmaceutical Co., Ltd."]