[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adenocarcinoma-of-the-stomach\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adenocarcinoma-of-the-stomach":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,46,72,104,129,168,190],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100594039","therapeutic-study-of-177lu-ctr-fapi-in-advanced-metastatic-digestive-malignancies-100594039",false,"NCT07014254","Therapeutic Study of 177Lu-CTR-FAPI in Advanced Metastatic Digestive Malignancies","Therapeutic Study of 177Lu-CTR-FAPI-targeted Nuclear Drugs in Advanced Metastatic Digestive Malignancies","Inclusion Criteria:\n\n* 1\\. voluntary participation in this study and signing of informed consent;\n* 2\\. age 18-75 years (both 18 and 75 years);\n* 3\\. ECOG (Eastern Cooperative Oncology Group) physical status score: 0-1;\n* 4.Advanced metastatic gastrointestinal malignancies with high FAP expression: e.g. neuroendocrine tumours (NET G2, G3), neuroendocrine carcinomas (NEC), pancreatic ductal adenocarcinomas (PDAC), gastric adenocarcinomas, colorectal carcinomas, intrahepatic cholangiocarcinomas (ICC), and squamous carcinomas of the oesophagus. All of the above should be confirmed by 68Ga-FAPI PET\u002FCT with high FAP expression (criterion: more than 50% of lesions with SUVmax ≥10). 5.\n* 5\\. Disease status: locally advanced unresectable or metastatic lesions confirmed by imaging (CT\u002FMRI\u002FPET-CT); at least 1 measurable lesion (RECIST 1.1 criteria).\n* 6\\. good major organ function, i.e. the following criteria are met (no blood components, cell growth factors are allowed within 14 days prior to the first dose)\n\n  1. Creatinine clearance ≥ 50 ml\u002Fmin (calculated according to the Cockcroft-Gault formula) or serum creatinine ≤ 150 μmol\u002FL;\n  2. Urine protein \\\u003C2+; if urine protein ≥2+, then 24-hour urine protein quantification must show \\\u003C2 g of protein;\n  3. White blood cell count ≥ 2 × 109\u002FL;\n  4. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL;\n  5. Platelets ≥ 75 × 109\u002FL;\n  6. Haemoglobin ≥ 8.0 g\u002FdL;\n  7. Serum albumin ≥ 30 g\u002FL.\n  8. Total bilirubin ≤ 3 × ULN;\n* 7\\. Women of childbearing age who undergo a blood pregnancy test within 72 h prior to treatment need to be excluded from pregnancy and must be non-lactating and willing to use a highly effective method of contraception for the duration of the trial and for 6 months after completion of treatment. For men, agreement to use a highly effective method of contraception or to have been surgically sterilised during the study and for 4 months after the end of treatment.\n\nExclusion Criteria:\n\n* 1\\. Disease-related:\n\n  1. Combination of other malignancies (except non-melanoma skin cancer or radical tumours without recurrence within 5 years);\n  2. Presence of central nervous system metastases or carcinomatous meningitis;\n  3. Uncontrolled cancer pain (requiring long-term high-dose opioids) or cachexia (≥20% weight loss in 6 months);\n  4. Diabetes mellitus (fasting blood glucose \\> 2 x ULN) that is not well controlled with optimal medical supportive therapy;\n  5. Accompanied by poorly controlled plasmapheresis, including pleural fluid, ascites, and pericardial effusion; controlled with treatment and stable (asymptomatic, not requiring interventional therapy, and stable on imaging) for ≥2 weeks may be included;\n  6. Severe urinary incontinence, hydronephrosis, severe voiding dysfunction or the need for an indwelling urinary catheter for any reason;\n  7. Subjects with uncontrolled cardiac clinical symptoms or disease, including but not limited to: i) NYHA class 2 or higher heart failure; ii) unstable angina; iii) myocardial infarction within 1 year prior to enrolment; iv) left ventricular ejection fraction (LVEF) \\\u003C50%; v) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;\n  8. Co-occurring active hepatitis B (HBV-DNA testing is required for HBsAg-positive individuals with HBV DNA ≥500 IU\u002FmL or 2500 copies\u002FmL), and hepatitis C (HCV-Ab-positive and above the lower limit of detection of the analytical method);\n  9. Persons known to have acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV) testing positive. Persons with active syphilis infection.\n* 2\\. Treatment related\n\n  1. Radiotherapy within 4 weeks or previous radiotherapy to \\>25% of the bone marrow area;\n  2. Received systemic anti-tumour therapy such as chemotherapy, immunotherapy, targeted therapy within 4 weeks;\n  3. Treatment with surgery (biopsy puncture, non-anti-tumour surgical operations such as ERCP may be excluded), radiofrequency ablation or cryoablation, interferon, transcatheter arterial embolisation (TAE) or transcatheter arterial chemoembolisation (TACE) within 12 weeks;\n  4. Prior FAP-targeted therapy (e.g., FAPI-PRRT, anti-FAP antibody drugs);\n  5. Presence of contraindications to radionuclide therapy (e.g., myelodysplastic syndrome, extensive bone metastases with bone marrow failure).\n\n     Comorbidities and Risks:\n  6. Previous antineoplastic therapy resulting in toxicity that has not recovered to grade ≤1 according to the NCI-CTCAE v5.0 classification (with the exception of lowered lymphocyte counts, alopecia, and the indicators mentioned in the inclusion criteria, and with the exception of partially tolerable chronic grade 2 toxicity, in the judgement of the investigator).\n* 3\\. Other exclusions\n\n  1. History of allergy to peptide radiopharmaceuticals;\n  2. Inability to co-operate with long-term follow-up (e.g., mental illness, geographical constraints, etc.);\n  3. Refusal of contraception by pregnant or lactating women or patients of childbearing age.","ALL","18 Years","80 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","This was a single-centre, single-arm, non-blinded, prospective study using 20 patients with advanced metastatic GI malignancies recruited to treat patients with advanced metastatic GI malignancies with 177Lu-CTR-FAPI to assess the safety of 177Lu-CTR-FAPI in advanced metastatic GI malignancies; this included radiation therapy dosimetry and initial treatment Determination of Effectiveness",[27,28,29,30],"Pancreatic Ductal Adenocarcinoma (PDAC)","Adenocarcinoma of the Stomach","Colorectal Cancer Metastatic","Neuroendocrine Tumor (NET)",[32],"177Lu-CTR-FAPI","NOT_YET_RECRUITING","2025-06-08",{"date":36,"type":37},"2025-06-10","ACTUAL",{"date":39,"type":21},"2025-06-20",{"date":41,"type":21},"2028-04-30",{"name":43,"class":44},"Xijing Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":45},"100565792","early-phase-1-phase-iit-trial-of-sna014-100565792","NCT06646783","Phase IIT Trial of SNA014","Clinical Study of 68GA-labeled Claudin 18.2 Developer Combined with PET\u002FCT for Imaging of Gastric or Gastroesophageal Junction Adenocarcinoma and Pancreatic Cancer","Inclusion Criteria:\n\n* Age range of 18 to 75 years old (including boundary values);\n* Individuals with behavioral capacity who voluntarily participate in this clinical study and sign an informed consent form (ICF);\n* Diagnosed G\u002FGEJ adenocarcinoma and pancreatic cancer;\n* Gastroscopy\u002FCT\u002FMRI\u002FPET-CT examination results within the past month (if any);\n* Pathological test results and Claudin18.2 immunohistochemistry results within the past year (if available).\n\nExclusion Criteria:\n\n* Merge patients with other clearly diagnosed malignant tumors:\n* Uncontrolled severe infections or individuals with other serious illnesses;\n* Those with an expected survival period of less than or equal to three months;\n* Pregnant or lactating patients, as well as reproductive age patients who refuse to take appropriate contraceptive measures during this trial;\n* investigators determine that patients who are not suitable to participate in this study;","75 Years",{"count":55,"type":21},28,[57],"EARLY_PHASE1","68Ga labeled Claudin 18.2 contrast agent combined with PET\u002FCT for gastric or gastroesophageal junction",[28,60,61],"Adenocarcinoma of GE Junction","Pancreatic Cancer Stage","2024-10-15",{"date":64,"type":37},"2024-10-17",{"date":66,"type":21},"2024-10-20",{"date":68,"type":21},"2025-11-20",{"name":70,"class":71},"SmartNuclide Biopharma","INDUSTRY",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100494265","phase-2-perioperative-chemotherapy-plus-trastuzumab-plus-toripalimab-in-her2-positive-locally-advanced-gastric-or-esophagogastric-junction-adenocarcinoma-100494265","NCT05715931","Perioperative Chemotherapy Plus Trastuzumab Plus Toripalimab in HER2 Positive Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma","A Multi-center, Phase II Study to Evaluate Efficacy and Safety of Perioperative Chemotherapy With Fluorouracil, Leucovorin, Oxaliplatin, Docetaxel (FLOT) and Trastuzumab in Combination With Toripalimab in Patients With HER2 Positive Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma","Inclusion Criteria:\n\n* Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF).\n* The gender is not limited. Age: ≥ 18 years and ≤ 80 years old.\n* Gastric or esophagogastric junction adenocarcinoma confirmed by pathology.\n* HER2-positive status defined as either IHC score of 3+ or IHC 2+ with amplification proven by fluorescent in situ hybridization (FISH) based on pretreatment endoscopic biopsies.\n* Clinical stage at presentation: cT2-T4b, N+\u002F-, M0 as determined by AJCC staging system, 8th edition.\n\n  * The definition of metastatic lymph nodes: a lymph node must be ≥ 10mm in short axis when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm) according to the guideline of Response Evaluation Criteria in Solid Tumours (RECIST version 1.1)\n* Participants with a performance status of 0 \\~ 1 on the Eastern Cooperative Oncology Group (ECOG) within 7 days before the first dose of study treatment.\n* Life expectancy ≥ 6 months.\n* Agreement of providing pretreatment endoscopic biopsies specimens and surgical specimens for biomarker analysis, as well as the peripheral blood, feces and urine sample.\n* The functions of the vital organs meet requirements as follow (within 14 days before the first dose of study treatment, participant has not received treatment of recombinant human thrombopoietin or granulocyte stimulating factor):\n\n  1. Hematological function：\n\n     * White blood cell count (WBC): 3.5 × 10 \\^ 9 \u002F L \\~12.0 × 10 \\^ 9 \u002F L；\n     * Absolute neutrophil count (ANC) ≥ 1.5 × 10 \\^ 9 \u002F L；\n     * Platelet count (PLT) ≥ 100 × 10 \\^ 9 \u002F L；\n     * Hemoglobin (Hb) ≥ 90 g \u002F L.\n  2. Hepatic function：\n\n     * Total bilirubin (TBIL) ≤ 1.5 × ULN (upper limit of normal);\n     * Aspartate aminotransferase (AST) ≤ 2.5 × ULN;\n     * Alanine aminotransferase (ALT) ≤ 2.5 × ULN;\n     * Albumin (ALB) ≥ 30 g \u002F L.\n  3. Renal function：\n\n     * Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 60 ml \u002F min for those with creatinine level \\> 1.5 × ULN.\n  4. Coagulation function：\n\n     * International normalized ratio (INR) ≤ 1.5;\n     * Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n  5. Cardiac function:\n\n     * The left ventricular ejection fraction (LVEF) value ≥ 55 %, as assessed by echocardiography\n* Female of childbearing age must meet requirements: urine or serum pregnancy test must be negative within 7 days before the first dose of study treatment, and she must agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of toriplimab, or 210 days after the last dose of trastuzumab, or 180 days after the last dose of chemotherapy, whichever is longer, and should not be breastfeeding. For the male participants must meet requirements: agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of toriplimab, or 210 days after the last dose of trastuzumab, or 180 days after the last dose of chemotherapy, whichever is longer).\n\nExclusion Criteria:\n\n* Prior systemic therapy for treatment of gastric cancer (surgery, chemotherapy, radiotherapy, targeted therapy or immunotherapy).\n* Previous or concurrent have other active malignant tumors within the past 5 years (except for basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate cancer or cervical cancer or breast cancer in situ that has undergone curative therapy).\n* Participants with gastric outlet obstruction, or unable for oral take, or severe gastrointestinal bleeding.\n* Myocardial infarction within 6 months before the first dose of study treatment, uncontrolled angina, arrhythmia which need medical intervention (including but not limited to cardiac pacemaker), congestive heart failure (New York Heart Association (NYHA) class III or IV).\n* Existence of chronic diarrhea (watery diarrhea: ≥ 5 times per day).\n* Participants with active infection within 14 days before the first dose of study treatment which need medical intervention.\n* Participants with active tuberculosis.\n* Previous or concurrent diagnosed with interstitial lung disease by imaging or symptoms.\n* Any of the following test is positive: Human Immunodeficiency Virus (HIV) antibody, Hepatitis B surface Antigen (HBsAg), or Hepatitis C Virus (HCV) antibody.\n* Participants who need long-term systemic steroid therapy (\\> 10 mg\u002Fd prednisone equivalent) or any other form of immunosuppressive therapy within 14 days before the first dose of study treatment or during the study period.\n* Concurrent or previous have severe allergic reaction to any antibody-based drugs.\n* Existence of any concurrent autoimmune disease, excepting participants with diabetes mellitus type I, hypothyroidism requiring only hormone replacement therapy.\n* Receive live vaccines within 28 days before the first dose of study treatment or during the study period, excepting inactivated viral vaccines for seasonal influenza.\n* Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* Existence of systemic disease that is difficult to control despite treatment with several agents, for example, diabetes mellitus, hypertension, etc.\n* Existence of other serious physical or mental diseases or serious laboratory abnormalities that may increase the risk of participating in the study. Participants who were judged unsuitable as subjects of this trial by investigator.",{"count":80,"type":21},30,[82],"PHASE2","This study is a prospective, single arm, multi-center phase II clinical trial designed to evaluate the efficacy and safety of perioperative chemotherapy with FLOT regimen and trastuzumab in combination with toripalimab in participants with resectable HER2 positive locally advanced gastric or esophagogastric junction adenocarcinoma.",[28,85,86],"Adenocarcinoma of Esophagogastric Junction","HER2-positive Gastric Cancer",[88,89,90,91,92],"Gastric Adenocarcinoma","Esophagogastric Junction Adenocarcinoma","Perioperative Chemotherapy","Trastuzumab","Toripalimab","RECRUITING","2024-09-14",{"date":96,"type":37},"2024-09-19",{"date":98,"type":37},"2023-02-28",{"date":100,"type":21},"2028-03-01",{"name":102,"class":44},"Yu jiren",8,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100506307","phase-2-perioperative-chemotherapy-combined-with-serplulimab-or-placebo-for-pmmr-locally-advanced-gastric-adenocarcinoma-focus-05-100506307","NCT05872685","Perioperative Chemotherapy Combined With Serplulimab or Placebo for pMMR Locally Advanced Gastric Adenocarcinoma (FOCUS-05)","Perioperative S-1 Plus Oxaliplatin Combined With Serplulimab or Placebo for Locally Advanced Gastric Adenocarcinoma With Proficient Mismatch Repair: a Prospective, Multi-center, Double-blinded, Randomized Placebo-controlled Study","Inclusion Criteria:\n\n1. Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF).\n2. The gender is not limited. Age: ≥ 18 years and ≤ 80 years old.\n3. Gastric or esophagogastric junction adenocarcinoma confirmed by pathology, and proficient mismatch repair confirmed by immunohistochemistry.\n4. Clinical stage at presentation: cT2-T4b, N+\u002F-, M0 as determined by AJCC staging system, 8th edition.The definition of metastatic lymph nodes: a lymph node must be ≥ 10mm in short axis when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm) according to the guideline of Response Evaluation Criteria in Solid Tumours (RECIST version 1.1)\n5. Participants with a performance status of 0 \\~ 1 on the Eastern Cooperative Oncology Group (ECOG) within 7 days before the first dose of study treatment.\n6. Life expectancy ≥ 6 months.\n7. Agreement of providing pretreatment endoscopic biopsies specimens and surgical specimens for biomarker analysis, as well as the peripheral blood, feces and urine sample.\n8. The functions of the vital organs meet requirements as follow (within 14 days before the first dose of study treatment, participant has not received treatment of recombinant human thrombopoietin or granulocyte stimulating factor):\n\n   8.1 Hematological function： White blood cell count (WBC): 3.5 × 10 \\^ 9 \u002F L \\~12.0 × 10 \\^ 9 \u002F L； Absolute neutrophil count (ANC) ≥ 1.5 × 10 \\^ 9 \u002F L； Platelet count (PLT) ≥ 100 × 10 \\^ 9 \u002F L； Hemoglobin (Hb) ≥ 90 g \u002F L.\n\n   8.2 Hepatic function： Total bilirubin (TBIL) ≤ 1.5 × ULN (upper limit of normal); Aspartate aminotransferase (AST) ≤ 2.5 × ULN; Alanine aminotransferase (ALT) ≤ 2.5 × ULN; Albumin (ALB) ≥ 30 g \u002F L.\n\n   8.3 Renal function： Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 60 ml \u002F min for those with creatinine level \\> 1.5 × ULN.\n\n   8.4 Coagulation function： International normalized ratio (INR) ≤ 1.5; Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n9. Female of childbearing age must meet requirements: urine or serum pregnancy test must be negative within 7 days before the first dose of study treatment, and she must agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of serplulimab, or 180 days after the last dose of chemotherapy, whichever is longer, and should not be breastfeeding.\n10. For the male participants must meet requirements: agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of serplulimab, or 180 days after the last dose of chemotherapy, whichever is longer).\n\nExclusion Criteria:\n\n1. HER2-positive, EBER-positive or dMMR.\n2. Prior systemic therapy for treatment of gastric cancer (surgery, chemotherapy, radiotherapy, targeted therapy or immunotherapy).\n3. Previous or concurrent have other active malignant tumors within the past 5 years (except for basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate cancer or cervical cancer or breast cancer in situ that has undergone curative therapy).\n4. Participants with gastric outlet obstruction, or unable for oral take, or severe gastrointestinal bleeding.\n5. Myocardial infarction within 6 months before the first dose of study treatment, uncontrolled angina, arrhythmia which need medical intervention (including but not limited to cardiac pacemaker), congestive heart failure (New York Heart Association (NYHA) class III or IV).\n6. Existence of chronic diarrhea (watery diarrhea: ≥ 5 times per day).\n7. Participants with active infection within 14 days before the first dose of study treatment which need medical intervention.\n8. Participants with active tuberculosis.\n9. Previous or concurrent diagnosed with interstitial lung disease by imaging or symptoms.\n10. Any of the following test is positive: Human Immunodeficiency Virus (HIV) antibody, Hepatitis B surface Antigen (HBsAg), or Hepatitis C Virus (HCV) antibody.\n11. Participants who need long-term systemic steroid therapy (\\> 10 mg\u002Fd prednisone equivalent) or any other form of immunosuppressive therapy within 14 days before the first dose of study treatment or during the study period.\n12. Concurrent or previous have severe allergic reaction to any antibody-based drugs.\n13. Existence of any concurrent autoimmune disease, excepting participants with diabetes mellitus type I, hypothyroidism requiring only hormone replacement therapy.\n14. Receive live vaccines within 28 days before the first dose of study treatment or during the study period, excepting inactivated viral vaccines for seasonal influenza.\n15. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n16. Existence of systemic disease that is difficult to control despite treatment with several agents, for example, diabetes mellitus, hypertension, etc.\n17. Existence of other serious physical or mental diseases or serious laboratory abnormalities that may increase the risk of participating in the study. Participants who were judged unsuitable as subjects of this trial by investigator.",{"count":112,"type":21},314,[82],"This phase II study is a prospective, multi-center, double-blinded, and randomized trial to compare the efficacy and safety of perioperative SOX plus serplulimab with SOX plus placebo for locally advanced gastric adenocarcinoma with proficient mismatch repair",[28,85,116],"Proficient Mismatch Repair",[88,90,118,119],"Serplulimab","Proficient mismatch repair","2024-01-15",{"date":122,"type":37},"2024-01-17",{"date":124,"type":37},"2023-12-24",{"date":126,"type":21},"2029-04-30",{"name":102,"class":44},5,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":140,"conditions":141,"keywords":150,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":45},"100525435","phase-2-radiotherapy--chemoimmunotherapy-followed-by-surgery-in-patients-with-limited-metastatic-gastric-or-gej-cancer-100525435","NCT06121700","Radiotherapy + Chemoimmunotherapy Followed by Surgery in Patients With Limited Metastatic Gastric or GEJ Cancer","Radiotherapy, Chemotherapy and Anti-PD-1 Immunotherapy Followed by Surgical Resection in Patients With Limited Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Single Arm, Phase II Trial","Miracle-G","Inclusion Criteria:\n\n1. Histopathologically confirmed adenocarcinoma of stomach (G) or gastroesophageal junction (GEJ) (excluding Siewert type I).\n2. Limited metastatic status of disease.\n3. At least one evaluable lesion in CT\u002FMRI according to RESIST 1.1 is required.\n4. The status of HER2 is clear.\n5. pMMR\u002FMSS confirmed by immunohistochemistry or gene test.\n6. Male or female. Patient age ≥ 18 years and ≤ 75 years.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.\n8. Physical state or organ function can tolerate the planned treatment of the study protocol, including systematic chemotherapy, immunotherapy with anti-PD-1 monoclonal antibody (mAb), primary lesion radiotherapy, metastatic lesion radiotherapy, and surgical resection of primary and\u002For metastatic lesions.\n9. No previous surgery or antitumor therapies, including chemotherapy, radiotherapy, or immunotherapy, were administered.\n10. Adequate hematological function: absolute neutrophil count (ANC) ≥ 1.5×109\u002FL; platelet count ≥ 100×109\u002FL; hemoglobin level ≥ 90 g\u002FL.\n11. Adequate hepatic function: total bilirubin ≤ 1.5×upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) \\\u003C 2.5 × ULN in the absence of liver metastases, or \\\u003C 5 × ULN in case of liver metastases; ALP ≤ 2.5×ULN; ALB ≥ 30 g\u002FL.\n12. Adequate renal function: serum creatinine ≤ 1.5×ULN; creatinine clearance rate ≥ 60 ml\u002Fmin.\n13. Adequate coagulation function: INR\u002FPT ≤ 1.5×ULN; APTT ≤ 1.5×ULN.\n14. TSH is within the normal range; if TSH is out of the normal range, FT3 and FT4 should be investigated. If the test results of FT3\u002FFT4 cannot be obtained, T3 and T4 can be accepted. 13. If the level of T3\u002FT4 is normal, the patients can be selected.\n15. Urine test: urine protein\\\u003C2+; if the urine protein≥2+, the 24-hour urine protein quantification must be≤1g.\n16. There is no serious concomitant disease, and the patient's life expectancy is more than 6 months.\n17. Patients agree to sign written informed consent before recruitment.\n18. Patients are willing and able to follow the protocol during the study, including receiving treatment and scheduled follow-up and examination.\n19. Patients are willing to provide samples of blood and tissue.\n20. Female patients should not be pregnant or breast feeding.\n21. Female patients agree to take contraceptive measures during treatment and within 120 days after the last dose of anti-PD-1 mAb or 180 days after the last use of chemotherapy or radiotherapy.\n\nDefinition of the limited metastatic disease:\n\n1. Retroperitoneal lymph node metastases (RPLM) only or at maximum one organ involved with or without RPLM.\n2. There is no peritoneal seeding on diagnostic laparoscopy (P0).\n3. The definition of RPLM includes but is not limited to para-aortal, intra-aorto-caval, parapancreatic or mesenteric lymph nodes. If the duodenum is invaded, retropancreatic nodes are not regarded as M1.\n4. The definition of single organ metastasis in the study is as follows: a) Liver: maximum of 5 metastatic lesions that are potentially resectable and the metastases should be limited to one lobe and not involve important blood vessels or bile ducts. b) Lung: unilateral involvement, potentially resectable. c) Ovary: uni- or bilateral Krukenberg tumors in the absence of macroscopic peritoneal carcinomatosis. d) Adrenal gland: uni- or bilateral metastases. e) Extra-abdominal lymph node metastases, such as supraclavicular or cervical lymph node involvement. f) Bone: localized bone involvement (defined as being within one radiation field).\n5. Other metastatic disease locations are considered, limited by the investigator and confirmed by the multidisciplinary team (MDT).\n\nExclusion Criteria:\n\n1. Patients who have previously received surgery, chemotherapy, radiotherapy or immunotherapy for gastric cancer.\n2. Patients have a history of cancer in the five years before enrollment except for squamous or basal cell carcinoma of the skin that was effectively treated and superficial bladder cancer, cervical carcinoma in situ and breast cancer in situ that was treated by operation.\n3. Pregnant or lactating females or females planning to become pregnant or lactating. Women of childbearing age with a positive pregnancy test or without a pregnancy test in the baseline period. Menopausal women must have stopped menstruating for at least 12 months before being considered to have no chance of pregnancy.\n4. Patients who had sexual activity (with the possibility of childbirth) and were unwilling to use contraception during the study period.\n5. Patients with a history of allergies to any drugs that may be used in this study, including chemotherapy drugs.\n6. History of allogeneic stem cell transplantation or organ transplantation.\n7. Vaccinated with live vaccine within 28 days before recruitment.\n8. Immunotherapy (interleukin, interferon, thymine) or other experimental treatment was given 28 days before enrollment.\n9. History of anti-PD-1, PD-L1, PD-L2 or any other specific T-cell costimulation or checkpoint pathway targeted therapy.\n10. History of using steroids (dose \\> 10 mg\u002Fd prednisone) or other systemic immunosuppressive therapy within 14 days before recruitment, except for patients treated with the following regimen: steroids used for hormone replacement (dose \\> 10 mg\u002Fd prednisone); local application of steroids with little systemic absorption; short-term (≤ 7 days) use of steroids to prevent allergy or vomiting.\n11. Patients with weight loss of more than 20% within 2 months before recruitment.\n12. Uncontrolled systemic diseases, including diabetes, hypertension, etc.\n13. Uncontrollable pleural effusion, pericardial effusion, or ascites occurred within two weeks before recruitment.\n14. Failure of important organs (heart, lung, liver, kidney, etc.).\n15. Moderate or severe renal injury \\[creatinine clearance ≤ 50 ml\u002Fmin (according to Cockcroft \\& Gault equation)\\], or SCR \\> ULN.\n16. Dipyrimidine dehydrogenase (DPD) deficiency.\n17. Patients with central nervous system (CNS) disorders or tumors, including brain metastases, peripheral nervous system disorders or psychiatric diseases.\n18. Cerebrovascular accidents occurred within 6 months before recruitment.\n19. Patients with peripheral neuropathy of NCI-CTCAE grade 1, except for those with disappearance of the deep tendon reflex.\n20. Patients with a known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and hypertension, congestive heart failure, cardiac infarction or cardiac insufficiency within 6 months prior to study recruitment.\n21. Pulmonary embolism occurred within 28 days before enrollment.\n22. Patients who had the following history of pulmonary diseases: interstitial lung disease, noninfectious pneumonia, pulmonary fibrosis, or acute lung disease.\n23. Patients with gastrointestinal bleeding or a high risk of bleeding within the first 2 weeks of enrollment.\n24. Patients who experienced gastrointestinal perforation or fistula within 6 months prior to enrollment.\n25. Upper gastrointestinal obstruction, dysfunction or malabsorption syndrome may affect the absorption of oral chemotherapy drugs.\n26. Patients who cannot swallow or take medication orally.\n27. Patients with a history of active autoimmune disease or refractory autoimmune disease.\n28. Severe chronic or active infections requiring systemic antibiotics, antifungal or antiviral therapy, including tuberculosis and AIDS.\n29. Known history of human immunodeficiency virus (HIV) infection.\n30. Patients with untreated chronic hepatitis B or HBV-DNA exceeding 500 IU\u002Fml or HCV-RNA positive.\n31. Alcohol\u002Fdrug abuse and medical, psychological or social conditions may interfere with patients' participation in the study or have an impact on the evaluation of the study results.",{"count":138,"type":21},55,[82],"The goal of this clinical trial is to evaluate the efficacy and safety of radiotherapy combined with chemotherapy and anti-PD-1 immunotherapy followed by surgery for the primary and metastatic lesions in patients with limited metastatic gastric or gastroesophageal junction adenocarcinoma. The main questions it aims to answer are: 1) If the multimodal treatment which includes anti-PD-1 immunotherapy and local therapies will improve the survival of this group of patients. 2) If the multimodal treatment which includes anti-PD-1 immunotherapy and local therapies can be performed safely in this group of patients.\n\nParticipants will receive short course hypofractionated radiotherapy (HFRT) for the primary lesion, HFRT or stereotactic body radiotherapy (SBRT) for metastatic lesions, combined with systemic chemotherapy and anti-PD-1 immunotherapy. For patients with HER2-positive cancer (defined as IHC 3+ or 2+\u002FISH+), trastuzumab is used along with chemotherapy and anti-PD-1 antibody. Then, surgical resections of primary and metastatic lesions are performed as much as possible. For patients who need a widely invasive surgical approach or are inoperable, local ablative therapies such as radiofrequency ablation (RFA) and microwave ablation (MVA) can be alternatives. For patients undergoing surgical resections, postoperative treatment includes chemotherapy, which is determined by the researcher, and PD-1 antibody, which will be maintained until one year after surgery.",[142,143,144,145,146,147,28,148,149],"Adenocarcinoma","Stomach Neoplasm","Gastroesophageal-junction Cancer","Oligometastatic Disease","Metastatic Cancer","Metastatic Gastric Cancer","Gastroesophageal Junction Adenocarcinoma","Metastatic Adenocarcinoma",[151,152,153,154,155,156,157,158],"gastric cancer","GEJ Cancer","oligometastasis","limited metastatic","hypofractionated radiotherapy","immunotherapy","gastrectomy","metastasectomy","2023-11-07",{"date":161,"type":37},"2023-11-08",{"date":163,"type":37},"2023-01-01",{"date":165,"type":21},"2027-12-31",{"name":167,"class":44},"Fudan University",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":176,"briefSummary":177,"conditions":178,"keywords":180,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":103},"100513834","phase-2-perioperative-chemotherapy-plus-toripalimab-for-epstein-barr-virus-associated-locally-advanced-gastric-or-esophagogastric-junction-adenocarcinoma-100513834","NCT05970627","Perioperative Chemotherapy Plus Toripalimab for Epstein-Barr Virus-associated Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma","Perioperative Chemotherapy Combined With PD-1 Inhibitor (Toripalimab) for Treatment of Epstein-Barr Virus-associated Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma: a Prospective, Multi-center, Phase II Study","Inclusion Criteria:\n\n1. Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF).\n2. Participants were ambulatory male or female. Age: ≥ 18 years and ≤ 80 years old.\n3. Histopathologically confirmed gastric or esophagogastric junction adenocarcinoma.\n4. Epstein-Barr Virus-associated Gastric or Esophagogastric Junction Adenocarcinoma, which was determined by in situ hybridization (ISH) test of endoscopic biopsy specimen.\n5. cT2-4bN+\u002F-, M0 according to the American Joint Committee on Cancer and Union for International Cancer Control (AJCC-UICC) TNM classification for carcinoma of the stomach (8th edition).\n6. Participants had Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1 within 7 days before the first dose of study treatment.\n7. Life expectancy ≥ 6 months.\n8. Agreement of providing baseline and surgical specimens for biomarker analysis.\n9. The functions of the vital organs meet requirements as follows (within 14 days before the first dose of study treatment, meanwhile, participants had not received treatment of recombinant human thrombopoietin or granulocyte stimulating factor):\n\n1). Hematological function\n\n* White blood cell count (WBC): 3.5 × 10\\^9\u002FL \\~12.0 × 10\\^9\u002FL\n* Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL\n* Platelet count (PLT) ≥ 100 × 10\\^9\u002FL\n* Hemoglobin (Hb) ≥ 90g\u002FL. 2). Hepatic function\n\n  * Total bilirubin (TBIL) ≤ 1.5 × ULN (upper limit of normal); -Aspartate aminotransferase (AST) ≤ 2.5 × ULN;\n  * Alanine aminotransferase (ALT) ≤ 2.5 × ULN;\n  * Albumin (ALB) ≥ 30g\u002FL. 3). Renal function\n  * Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 60 ml\u002Fmin for those with creatinine level \\> 1.5 × ULN.\n\n    4). Coagulation function\n  * International normalized ratio (INR) ≤ 1.5;\n  * Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n\n    10\\. Female participants of childbearing age must meet requirements: urine or serum pregnancy test must be negative within 7 days before the first dose of study treatment, and she must agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of toripalimab, or 180 days after the last dose of chemotherapy, whichever is longer, and should not be breastfeeding. Male participants must meet requirements: agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of toripalimab, or 180 days after the last dose of chemotherapy, whichever is longer).\n\nExclusion Criteria:\n\n1. HER2-positive status defined as either IHC score of 3+ or IHC 2+ with amplification proven by fluorescent in situ hybridization (FISH) based on pretreatment endoscopic biopsies.\n2. Prior systemic therapy for treatment of gastric cancer (surgery, chemotherapy, radiotherapy, targeted therapy or immunotherapy).\n3. Previous or concurrent have other active malignant tumors within the past 5 years (except for basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate cancer or cervical cancer or breast cancer in situ that has undergone curative therapy).\n4. Participants with gastric outlet obstruction, or unable to oral take, or severe gastrointestinal bleeding.\n5. Myocardial infarction within 6 months before the first dose of study treatment, uncontrolled angina, arrhythmia which need medical intervention (including but not limited to cardiac pacemaker), congestive heart failure (New York Heart Association (NYHA) class III or IV).\n6. Existence of chronic diarrhea (watery diarrhea: ≥ 5 times per day).\n7. Participants with active infection within 14 days before the first dose of study treatment which need medical intervention.\n8. Participants with active tuberculosis.\n9. Previous or concurrent diagnosed with interstitial lung disease by imaging or symptoms.\n10. Any of the following test is positive: Human Immunodeficiency Virus (HIV) antibody, Hepatitis B surface Antigen (HBsAg), or Hepatitis C Virus (HCV) antibody.\n11. Participants who need long-term systemic steroid therapy (\\> 10 mg\u002Fd prednisone equivalent) or any other form of immunosuppressive therapy within 14 days before the first dose of study treatment or during the study period.\n12. Concurrent or previous have severe allergic reaction to any antibody based drugs.\n13. Existence of any concurrent autoimmune disease, excepting participants with diabetes mellitus type I, hypothyroidism requiring only hormone replacement therapy.\n14. Receive live vaccines within 28 days before the first dose of study treatment or during the study period, excepting inactivated viral vaccines for seasonal influenza.\n15. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n16. Existence of systemic disease that is difficult to control despite treatment with several agents, for example, diabetes mellitus, hypertension, etc.\n17. Existence of other serious physical or mental diseases or serious laboratory abnormalities that may increase the risk of participating in the study. Participants who were judged unsuitable as subjects of this trial by investigator.",{"count":80,"type":21},[82],"This study is a prospective, single arm, multi-center phase II clinical trial designed to evaluate the efficacy and safety of perioperative SOX combined with toripalimab in participants with Epstein-Barr Virus-associated locally advanced gastric or esophagogastric junction adenocarcinoma.",[28,85,179],"Epstein-Barr Virus-Associated Gastric Carcinoma",[88,89,90,92,181],"Epstein-Barr Virus-associated gastric cancer","2023-07-25",{"date":184,"type":37},"2023-08-01",{"date":186,"type":21},"2023-07-28",{"date":188,"type":21},"2029-07-28",{"name":102,"class":44},{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":197,"targetDuration":4,"studyType":22,"phases":199,"briefSummary":200,"conditions":201,"keywords":203,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":103},"100495320","phase-2-perioperative-chemotherapy-plus-toripalimab-for-dmmr-locally-advanced-gastric-or-esophagogastric-junction-adenocarcinoma-100495320","NCT05729646","Perioperative Chemotherapy Plus Toripalimab for dMMR Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma","Perioperative S-1 Plus Oxaliplatin Combined With Toripalimab or Toripalimab Monotherapy Versus S-1 Plus Oxaliplatin for Treatment of dMMR Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma: a Prospective, Multi-center, Randomized Controlled Study","Inclusion Criteria:\n\n1. Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF).\n2. Participants were ambulatory male or female. Age: ≥ 18 years and ≤ 80 years old.\n3. Histopathologically confirmed gastric or esophagogastric junction adenocarcinoma.\n4. Mismatch repair deficient (dMMR) adenocarcinoma, which was determined by immunohistochemistry (ICH) test of endoscopic biopsy specimen. dMMR was defined as loss of nuclear expression of one or more MMR proteins.\n5. cT2-4bN+\u002F-, M0 according to the American Joint Committee on Cancer and Union for International Cancer Control (AJCC-UICC) TNM classification for carcinoma of the stomach (8th edition).\n6. Participants had Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1 within 7 days before the first dose of study treatment.\n7. Life expectancy ≥ 6 months.\n8. Agreement of providing baseline and surgical specimens for biomarker analysis.\n9. The functions of the vital organs meet requirements as follows (within 14 days before the first dose of study treatment, meanwhile, participants had not received treatment of recombinant human thrombopoietin or granulocyte stimulating factor):\n\n1). Hematological function#\n\n-White blood cell count (WBC): 3.5 × 10\\^9\u002FL \\~12.0 × 10\\^9\u002FL\n\n-Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL\n\n-Platelet count (PLT) ≥ 100 × 10\\^9\u002FL\n\n* Hemoglobin (Hb) ≥ 90g\u002FL. 2). Hepatic function\n* Total bilirubin (TBIL) ≤ 1.5 × ULN (upper limit of normal); -Aspartate aminotransferase (AST) ≤ 2.5 × ULN;\n* Alanine aminotransferase (ALT) ≤ 2.5 × ULN;\n* Albumin (ALB) ≥ 30g\u002FL. 3). Renal function\n* Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 60 ml \u002F min for those with creatinine level \\> 1.5 × ULN.\n\n  4). Coagulation function#\n  * International normalized ratio (INR) ≤ 1.5;\n  * Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n\n    10\\. Female participants of childbearing age must meet requirements: urine or serum pregnancy test must be negative within 7 days before the first dose of study treatment, and she must agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of toriplimab, or 180 days after the last dose of chemotherapy, whichever is longer, and should not be breastfeeding. Male participants must meet requirements: agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of toriplimab, or 180 days after the last dose of chemotherapy, whichever is longer).\n\nExclusion Criteria:\n\n1. HER2-positive status defined as either IHC score of 3+ or IHC 2+ with amplification proven by fluorescent in situ hybridization (FISH) based on pretreatment endoscopic biopsies.\n2. Prior systemic therapy for treatment of gastric cancer (surgery, chemotherapy, radiotherapy, targeted therapy or immunotherapy).\n3. Previous or concurrent have other active malignant tumors within the past 5 years (except for basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate cancer or cervical cancer or breast cancer in situ that has undergone curative therapy).\n4. Participants with gastric outlet obstruction, or unable to oral take, or severe gastrointestinal bleeding.\n5. Myocardial infarction within 6 months before the first dose of study treatment, uncontrolled angina, arrhythmia which need medical intervention (including but not limited to cardiac pacemaker), congestive heart failure (New York Heart Association (NYHA) class III or IV).\n6. Existence of chronic diarrhea (watery diarrhea: ≥ 5 times per day).\n7. Participants with active infection within 14 days before the first dose of study treatment which need medical intervention.\n8. Participants with active tuberculosis.\n9. Previous or concurrent diagnosed with interstitial lung disease by imaging or symptoms.\n10. Any of the following test is positive: Human Immunodeficiency Virus (HIV) antibody, Hepatitis B surface Antigen (HBsAg), or Hepatitis C Virus (HCV) antibody.\n11. Participants who need long-term systemic steroid therapy (\\> 10 mg\u002Fd prednisone equivalent) or any other form of immunosuppressive therapy within 14 days before the first dose of study treatment or during the study period.\n12. Concurrent or previous have severe allergic reaction to any antibody- based drugs.\n13. Existence of any concurrent autoimmune disease, excepting participants with diabetes mellitus type I, hypothyroidism requiring only hormone replacement therapy.\n14. Receive live vaccines within 28 days before the first dose of study treatment or during the study period, excepting inactivated viral vaccines for seasonal influenza.\n15. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n16. Existence of systemic disease that is difficult to control despite treatment with several agents, for example, diabetes mellitus, hypertension, etc.\n17. Existence of other serious physical or mental diseases or serious laboratory abnormalities that may increase the risk of participating in the study. Participants who were judged unsuitable as subjects of this trial by investigator.",{"count":198,"type":21},90,[82],"This study is a prospective, multi-center, randomized controlled phase II trial to compare the efficacy of perioperative SOX plus toripalimab, toripalimab monotherapy with SOX regimen in participants with dMMR locally advanced gastric or esophagogastric junction adenocarcinoma",[28,85,202],"Mismatch Repair Deficiency",[88,89,90,92],"2023-07-24",{"date":182,"type":37},{"date":207,"type":37},"2023-05-31",{"date":209,"type":21},"2029-02-28",{"name":102,"class":44}]