[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adenocarcinoma-of-esophagogastric-junction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adenocarcinoma-of-esophagogastric-junction":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,45,74,104,125,150,172,192],{"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":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100624234","phase-1-clinical-study-of-im96-car-t-cell-therapy-in-patients-with-advanced-adenocarcinoma-of-gastricesophagogastric-junction-100624234",false,"NCT07406984","Clinical Study of IM96 CAR-T Cell Therapy in Patients With Advanced Adenocarcinoma of Gastric\u002FEsophagogastric Junction","A Phase I Clinical Study to Evaluate the Safety and Efficacy of IM96 CAR-T Cell Injection in Advanced Adenocarcinoma of Gastric\u002FEsophagogastric Junction","Inclusion Criteria:\n\n1. The age is 18 to 75 years (including boundary values) and the gender is not limited;\n2. Patients with advanced locally inoperable or metastatic adenocarcinoma of the stomach\u002Fgastric esophageal junction diagnosed by pathohistology;\n3. Patients with metastatic stomach\u002Fgastric esophageal junction who have failed or are intolerant to standard therapy;\n\n   Notes:\n   1. The standardized systemic treatment received by the patient must be in accordance with the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Treatment of Gastric Cancer, 2025 Edition;\n   2. The standard prior treatment regimen should incorporate therapeutic strategies guided by relevant molecular biomarkers. Specifically, patients with HER2-positive tumors must have received HER2-targeted therapy;\n   3. Claims of treatment intolerance: Patients who are unable to continue current effective systemic standardized treatment due to toxic side effects such as grade ≥3 vomiting, diarrhea, abdominal pain, bone marrow suppression, etc., and who do not accept refusal for financial and personal reasons;\n4. Presence of at least one measurable lesion that meets RECIST 1.1 criteria;\n5. Patients must provide a tumor sample within 2 years that meets the requirements (paraffin block or number of unstained sections that meet the testing requirements set by the Institute) that is positive for GUCY2C expression by immunohistochemistry;\n6. Eastern cooperative oncology group (ECOG) score of 0-1;\n7. Women of childbearing potential who have a negative blood pregnancy test prior to the start of the trial and who agree to use effective contraception during the trial and up to the last follow-up visit;male patients whose partners are of childbearing potential agree to use effective contraception during the trial and up to the last follow-up visit;\n8. Laboratory tests should meet at least the indicators specified below:\n\n   Hemoglobin (Hb) ≥ 80 g\u002FL; Neutrophil count (Absolute neutrophil count, ANC) ≥ 1.5 x 10\\^9\u002FL; Platelet count (PLT) ≥ 75 x 10\\^9\u002FL; Absolute lymphocyte value ≥ 0.6 x 10\\^9\u002FL; Lymphocytes make up ≥10% of white blood cells; Creatinine clearance ≥60 ml\u002Fmin; Alanine transaminase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 x ULN and total bilirubin (TBL) ≤ 1.5 x ULN (for elevations of ALT and AST that can be explained by hepatic aggression, the high limits for AST and ALT can be adjusted upward to 5-fold, and the high limit for TBL may be adjusted upward to 3-fold; Serum albumin ≥ 3.0 g\u002FdL; Prolongation of prothrombinogen time ≤ 4s;\n9. Left ventricular ejection fraction ≥ 50% with a normal ECG or an abnormal ECG that, in the judgment of the investigator, does not require treatment;\n10. Oxygen saturation \\>92% in non-oxygenated state;\n11. Vascular access is adequate for cell collection, and lines are available for patients with existing central venous catheters;\n12. Those who voluntarily participate in the trial and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Presence of brain metastases;\n2. Patients who have previously received or are awaiting an organ transplant;\n3. Toxicity due to prior therapy not stabilized or recovered to ≤ grade 1 (except in cases judged by the investigator to be not clinically significant);\n4. Plasmapheresis (e.g., pleural effusion, abdominal effusion, pericardial effusion) with symptoms of compression that cannot be controlled with treatment;\n5. Autoimmune disease requiring systemic immunosuppressive therapy (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus) within 2 years prior to the start of screening;\n6. Lung diseases that the inversgaters determined were not suitable for inclusion in the study;\n7. Use of any of the following medications or treatments during the designated time period prior to cell collection:\n\n   1. Therapeutic doses of corticosteroids have been used within 7 days prior to cell collection. However, topical and inhaled steroids are permitted;\n   2. Received chemotherapeutic agents within 1 week prior to cell collection. Enrollment was allowed if the oral chemotherapeutic drug had passed at least 3 half-lives prior to cell collection;\n   3. Those who used drugs to stimulate bone marrow hematopoietic cell production within 5 days prior to cell collection;\n   4. Use of study drug within 4 weeks prior to cell collection.However, enrollment was allowed if the trial treatment was ineffective or the disease progressed during the trial and at least 5 half-lives had elapsed prior to cell collection;\n   5. Received interventional therapy, radiotherapy, ablation, and other localized treatments for the study disease within 4 weeks prior to cell collection;\n   6. Patients who have had major surgery or significant trauma within 4 weeks prior to cell collection or who are expected to require major surgery during the study period;\n   7. Received targeted drug treatment such as apatinib or fuyiquatine within one week prior to cell collection;\n   8. Received immunotherapy drugs such as anti-PD-1\u002FPD-L1 within four weeks prior to cell collection;\n8. Prior treatment with anti-GUCY2C target (unless GUCY2C target test remains positive);\n9. Those who have received other cell therapy or genetically modified cell therapy in the past, such as TCR-T therapy, CAR-T therapy, etc;\n10. Prior or clinically significant CNS disorders at screening, such as epilepsy, epileptic seizures, cerebrovascular disease (ischemia\u002Fhemorrhage\u002Fcerebral infarction), cerebral edema, reversible posterior leukoencephalopathy, paralysis, aphasia, stroke, severe brain injury,dementia, Parkinson's disease, cerebellar disorders, organic brain syndromes, or psychiatric disorders;\n11. Chronic or active infection requiring systemic therapy and history of symptomatic viral infection that has not been completely cured. For example, Hepatitis B: patients who are positive for Hepatitis B surface antigen (HBsAg) and\u002For Hepatitis B core antibody (HBcAb) and whose peripheral blood HBV-DNA test is above the lower limit of detection;patients who are positive for Hepatitis C Virus Antibody (HCVAb) and whose peripheral blood HCV-RNA test is above the lower limit of detection; and patients infected with Human Immunodeficiency Virus (HIV), Syphilis;\n12. Active EBV and cytomegalovirus, defined as patients with IgM antibodypositive or IgM antibody-negative but higher-than-normal EBV-DNA in EBV serum; and cytomegalovirus (CMV) seropositive or IgM antibodynegative but higher-than-normal CMV-DNA in serum;\n13. Vaccination with live vaccine within 6 weeks prior to the start of screening;\n14. Abnormalities of cardiac function include: long QTc syndrome or QTc interval \\>480 ms; complete left bundle branch block, degree II\u002FIII AV block; severe, uncontrolled arrhythmias requiring pharmacologic therapy; history of chronic congestive heart failure with NYHA class ≥3 (refer to Attachment 3) with a cardiac ejection fraction of less than 50% in the 6 months prior to screening; CTC AE ≥3 grade heart valve disease;myocardial infarction, cardiac angioplasty or stenting,unstable angina, history of severe pericardial disease, or other clinically significant cardiac disease within 6 months prior to screening;\n15. Patients requiring anticoagulation therapy;\n16. Requires long-term use of medications that can affect clotting (e.g.,aspirin, warfarin, etc.);\n17. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to initiation of screening;\n18. Other untreated malignant tumors within the previous 5 years or concurrently, except cervical cancer in situ, basal cell carcinoma of the skin, and ductal carcinoma in situ of the breast;\n19. Infections (fungal, bacterial, viral, or other) that require intravenous antimicrobial control or are uncontrollable, for simple urinary tract infections, and for bacterial pharyngitis, may be enrolled if the investigator evaluates that they can be controlled by curative treatment;\n20. Patients with digestive tract obstruction;\n21. The primary lesion exhibits a large ulcer, conferring a high risk of hemorrhage or perforation; alternatively, imaging studies (CT or MRI), with or without adjunctive gastroscopy, demonstrate transmural tumor invasion-i.e., infiltration across the full thickness of the gastric wall-thereby elevating the patient's risk of hemorrhage or perforation;\n22. Patients present with unstable or active peptic ulcers, active gastrointestinal bleeding, or a history of major gastrointestinal bleeding within the preceding three months;\n23. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study;\n24. The presence of any factors affecting compliance with the protocol or the patient's unwillingness or inability to comply with the procedures required in the study protocol, as determined by the investigator.","ALL","18 Years","75 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study, a single-center, open, single-dose clinical study, was designed to evaluate the safety and efficacy of IM96 CAR-T cells in treating patients with advanced adenocarcinoma of gastric\u002Fesophagogastric junction",[27,28],"Adenocarcinoma of Gastric","Adenocarcinoma of Esophagogastric Junction",[30,31],"Advanced adenocarcinoma of gastric IM96 CAR-T","Advanced adenocarcinoma of esophagogastric junction IM96 CAR-T","NOT_YET_RECRUITING","2026-02-11",{"date":35,"type":36},"2026-02-13","ACTUAL",{"date":38,"type":21},"2026-03-05",{"date":40,"type":21},"2027-12-31",{"name":42,"class":43},"Beijing Immunochina Medical Science & Technology Co., Ltd.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":44},"100539210","a-prospective-study-on-esophagogastrostomy-by-an-innovative-surgical-technique-100539210","NCT06300879","A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique","A Prospective Study on the Perioperative Safety and Short-Term Quality of Life in Totally Laparoscopic Proximal Gastrectomy With Esophagogastrostomy by Fissure Technique","Inclusion Criteria:\n\n1. Age between 18 and 75 years old;\n2. Pathologically confirmed as adenocarcinoma;\n3. Primary tumor located in the upper 1\u002F3 of the stomach or the gastroesophageal junction (Siewert II or III);\n4. If it is adenocarcinoma of the upper 1\u002F3 of the stomach, cT1N0M0 should be met.\n5. For gastroesophageal junction adenocarcinoma, cT1-2N0M0 should be met, and clinical judgment should indicate no distant lymph node metastasis around the stomach.\n6. Bilateral resection margins should be greater than 2 cm, and more than half of the residual stomach should be preserved.\n7. No history of upper abdominal surgery (excluding laparoscopic cholecystectomy).\n8. No preoperative comprehensive treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.\n9. Preoperative ECOG (Eastern Cooperative Oncology Group) score of 0\u002F1.\n10. Preoperative ASA (American Society of Anesthesiologists) score I-III.\n11. Good function of important organs.\n12. Signed informed consent.\n\nExclusion Criteria:\n\n1. Preoperative assessment indicating cT4b or Bulky lymph nodes enlargement or distant lymph nodes metastasis;\n2. Pregnant or lactating women;\n3. Patients with severe mental illness;\n4. Preoperative temperature ≥38°C or infectious diseases requiring systemic treatment;\n5. Severe respiratory diseases, with FEV1 \\\u003C 50% of predicted value;\n6. History of other malignant tumors in the past 5 years;\n7. Severe liver or kidney dysfunction;\n8. Unstable angina or myocardial infarction within the last 6 months;\n9. History of stroke or cerebral hemorrhage within the last 6 months (excluding old infarcts);\n10. Systemic use of glucocorticoids within the last 1 month;\n11. Emergency surgery required due to complications of gastric cancer (bleeding, perforation, obstruction);\n12. Patient has participated in or is currently participating in other clinical trials (within the last 6 months).",{"count":53,"type":21},30,[55],"NA","This is a single-center, open-label, Phase Ib\u002FII study aiming to assess the perioperative safety and postoperative outcomes of a novel surgical technique in treating primary adenocarcinoma located in the upper 1\u002F3 of the stomach or gastroesophageal junction (Siewert II or III).\n\nThe study will enroll 30 patients who will undergo totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique. Clinical data will be collected to evaluate perioperative safety. Patients will be followed for at least 3 months, during which endoscopy will be performed to analyze occurrences and reasons for anastomotic-related complications. Additionally, the quality of life after surgery will be evaluated by QLQ-C30 and QLQ-STO22.",[58,28],"Gastric Cancer",[60,61,62],"proximal gastrectomy","totally laparoscopic gastrectomy","fissure technique","RECRUITING","2025-04-29",{"date":66,"type":36},"2025-05-02",{"date":68,"type":36},"2024-01-01",{"date":70,"type":21},"2026-06-30",{"name":72,"class":73},"Huashan Hospital","OTHER",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":5},"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.","80 Years",{"count":53,"type":21},[84],"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.",[87,28,88],"Adenocarcinoma of the Stomach","HER2-positive Gastric Cancer",[90,91,92,93,94],"Gastric Adenocarcinoma","Esophagogastric Junction Adenocarcinoma","Perioperative Chemotherapy","Trastuzumab","Toripalimab","2024-09-14",{"date":97,"type":36},"2024-09-19",{"date":99,"type":36},"2023-02-28",{"date":101,"type":21},"2028-03-01",{"name":103,"class":73},"Yu jiren",{"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":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":44},"100533217","phase-2-anlotinib-tqb2450-pd-l1-inhibitor-and-albumin-bound-paclitaxel-regimens-in-the-treatment-of-gcgeja-100533217","NCT06222944","Anlotinib, TQB2450 (PD-L1 Inhibitor), and Albumin-bound Paclitaxel Regimens in the Treatment of GC\u002FGEJA","A Multi-Center, Multi-Cohort Study of the Efficacy and Safety of Anlotinib, TQB2450, and Albumin-bound Paclitaxel in CLDN18.2-regimen-failed Gastric Cancer or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Voluntarily join this study, sign the informed consent form, and have good compliance;\n* Pathologically (histologically or cytologically) confirmed HER2\u002Fneu-negative (or HER2\u002Fneu status unclear) advanced gastric cancer or gastroesophageal junction adenocarcinoma;\n* Patients who have failed first-line treatment with CLDN18.2-related regimen (CLDN18.2 drugs include CLDN18.2 monotherapy, CLDN18.2 dual therapy, CLDN18.2 ADC or CLDN18.2 CART therapy, treatment regimen includes CLDN18.2 combined with chemotherapy or immunotherapy or other systemic therapy) and the time from the end of the last treatment with CLDN18.2-related drugs is more than two weeks;\n* According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, at least one measurable lesion, which can be accurately measured in at least one direction (the maximum diameter needs to be recorded) by magnetic resonance imaging (MRI) or computed tomography (CT), with the longest diameter at baseline ≥10 mm (if it is a lymph node, the short diameter is required to be ≥15 mm); the measurable lesions should not have received local treatment such as radiotherapy (lesions in the previous radiotherapy area, if confirmed to have progressed and meet the RECIST 1.1 criteria, can also be selected as target lesions);\n* Male or female patients aged ≥18 years and ≤75 years;\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0-1;\n* Expected survival ≥3 months;\n* Adequate organ function, requiring the following laboratory test values at screening:\n\n  * Hemoglobin (HB) ≥80g\u002FL (no blood transfusion within 14 days);\n  * Absolute neutrophil count (ANC) ≥1.5×109\u002FL;\n  * Platelet count (PLT) ≥75×109\u002FL (no use of interleukin 11 or TPO within 14 days);\n  * White blood cell count (WBC) ≥3.0×109\u002FL (no use of granulocyte stimulating factor within 14 days).\n  * Serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN);\n  * ALT and AST ≤2.5 ULN, if there is liver metastasis, then ALT and AST ≤5×ULN;\n  * Creatinine (Cr) ≤1.5 ULN or creatinine clearance rate (CCr) ≥60ml\u002Fmin, (Cockcroft-Gault formula);\n  * Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;\n  * Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%);\n  * Cardiac enzyme spectrum: within normal range;\n* Women of childbearing age must take appropriate contraceptive measures from screening to 3 months after stopping the study treatment and must be non-lactating patients. Serum or urine pregnancy test negative within 7 days before enrollment in the study, or meet one of the following criteria to prove that there is no risk of pregnancy:\n\n  * a) Postmenopausal is defined as age over 50 years and amenorrhea for at least 12 months after stopping all exogenous hormone replacement therapy;\n  * b) Women under 50 years of age, if amenorrhea for 12 months or more after stopping all exogenous hormone therapy, and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the laboratory postmenopausal reference range, can also be considered as postmenopausal;\n  * c) Have undergone irreversible sterilization surgery, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but excluding bilateral tubal ligation; For men, they must agree to use appropriate methods of contraception or have undergone surgical sterilization during the trial and 8 weeks after the last administration of the trial drug;\n\nExclusion Criteria:\n\n* For cohort 1, patients who have previously received anlotinib hydrochloride treatment or other anti-angiogenic small molecule tyrosine kinase inhibitors (TKIs) within 6 months. Patients who have stopped treatment with other anti-angiogenic small molecule TKIs for more than 6 months are allowed to enroll; For cohort 2 and cohort 3, patients who have received PD-L1 immune checkpoint inhibitor treatment in the first line are excluded, but patients who have received PD-1 or CTLA-4 immune checkpoint inhibitor treatment in the first line are allowed, if they have any of the following immune-related medical history and treatment history, they are excluded:\n\n  * Have any active autoimmune disease or history of autoimmune disease (such as but not limited to autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; requiring bronchodilators for medical intervention of asthma); but the following patients are allowed to enroll: vitiligo, psoriasis, alopecia that do not require systemic treatment, type I diabetes that is well controlled, hypothyroidism that has normal thyroid function after replacement therapy;\n  * Diagnosed with immunodeficiency or receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy (dose \\>10mg\u002Fday of prednisone or other equivalent hormones), and continuing to use it within 2 weeks before the first administration;\n  * Received any live vaccine, attenuated vaccine (including anti-infective vaccines, such as influenza vaccine, varicella vaccine, etc.), or inactivated vaccine within 4 weeks before enrollment and plan to receive live vaccine\u002Fattenuated vaccine\u002Finactivated vaccine during the study; used systemic immunostimulants (including but not limited to interferon and IL-2) within 2 weeks before the start of the study treatment;\n\nFor Cohort 3, patients who have previously received anlotinib hydrochloride or other anti-angiogenic small molecule tyrosine kinase inhibitors (TKIs) within 6 months. Patients who have stopped treatment with other anti-angiogenic small molecule TKIs for more than 6 months are allowed to enroll;\n\n* Patients who have received anti-tumor treatment with traditional Chinese medicine within the past two weeks (the traditional Chinese medicine contains the following medicinal materials such as Brucea javanica, Coix seed, Lentinan, Cantharidin, Toad skin, Astragalus, Sophora, Ugonin, Chebula, Icariin, etc.), but patients who have stopped taking anti-tumor treatment with traditional Chinese medicine for more than two weeks are allowed to enroll;\n* Patients who have received ≥1 other systemic systemic anti-tumor treatment (including but not limited to chemotherapy, immunotherapy, targeted therapy, and other systemic treatment regimens) after failing CLDN18.2-related regimen treatment, but palliative local treatment (including radiotherapy and other local treatment regimens) for local lesions (non-target lesions) \\>two weeks later are allowed to enroll;\n* Patients who have previously received allogeneic bone marrow transplantation or organ transplantation;\n* Congenital pulmonary fibrosis, drug-induced pneumonia, organizing pneumonia, or CT-confirmed active pneumonia;\n* Patients with symptomatic central nervous system metastases and\u002For carcinomatous meningitis. Patients with a history of central nervous system metastases or spinal cord compression, if they have received treatment and stopped using anticonvulsants and steroids 4 weeks before the first administration of the study and have clinically stable performance, can enroll in the study;\n* ≥ NCI CTCAE grade 2 peripheral neuropathy;\n* Infection requiring antibiotics within 14 days before the start of the trial;\n* Patients with bone metastases at risk of paraplegia;\n* Patients with any severe and\u002Funcontrolled disease, including:\n\n  * Patients with poor blood pressure control using antihypertensive drugs (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg); patients with grade II or higher myocardial ischemia or myocardial infarction, arrhythmia (including QT interval ≥480ms); patients with III-IV heart failure according to NYHA criteria or cardiac ultrasound examination suggesting left ventricular ejection fraction (LVEF) \\\u003C50%;\n  * Poorly controlled diabetes (fasting blood glucose (FBG) \\>10mmol\u002FL);\n  * Urinalysis suggests urine protein ≥++, and 24-hour urine protein quantification \\>1.0 g is confirmed;\n* Received major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks before the study, or expected to need major surgery during the study treatment, or non-diagnostic surgery within 4 weeks before the start of the trial;\n* History of gastrointestinal perforation and\u002For fistula within 6 months before enrollment; or history of arterial\u002Fvenous thromboembolic events, such as cerebrovascular accident (stable cerebral infarction excluded by researcher evaluation), deep vein thrombosis, and pulmonary embolism;\n* Clinically significant pleural effusion, including any pleural effusion that can be found by physical examination, pleural effusion that has been treated in the past or still needs treatment. Patients with only a small amount of pleural effusion shown by imaging but no symptoms, and who do not need treatment according to the researcher's evaluation, can be enrolled;\n* Body mass index (BMI) \\\u003C17.0 kg\u002Fm² or weight loss of ≥10% within 2 months before screening;\n* Patients with a history of psychotropic drug abuse and unable to quit or have mental disorders;\n* Patients with active hepatitis B or hepatitis C, HIV-positive patients, patients with active tuberculosis;\n* CT suggests definite ulcerative lesions, or occult blood in stool ++ or above;\n* History of abnormal bleeding (except epistaxis) within 1 month before enrollment;\n* History of other primary malignant tumors, except for the following: 1) Malignant tumors that have been completely remitted for at least 2 years before enrollment and do not require other treatment during the study; 2) Non-melanoma skin cancer or malignant melanocytic nevus that have been adequately treated and have no evidence of disease recurrence; 3) In situ carcinoma that has been adequately treated and has no evidence of disease recurrence;\n* Pregnant or lactating female patients;\n* According to the researcher's judgment, patients with severe accompanying diseases that endanger the patient's safety or affect the patient's completion of the study;\n* Participated in other trials within 30 days before the start of the trial, or plan to participate in other trials during the trial.",{"count":112,"type":21},90,[84],"This study aims to assess the efficacy and safety of a combination therapy consisting of Anlotinib, TQB2450 (a PD-L1 inhibitor), and Albumin-bound Paclitaxel regimens in patients with advanced gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJA) who have failed the previous treatment with Claudin18.2 (CLDN18.2)-related regimens.",[58,28],"2024-01-16",{"date":118,"type":36},"2024-01-25",{"date":120,"type":21},"2024-02-25",{"date":122,"type":21},"2026-08-25",{"name":124,"class":73},"Peking University",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":81,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},"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":133,"type":21},314,[84],"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",[87,28,137],"Proficient Mismatch Repair",[90,92,139,140],"Serplulimab","Proficient mismatch repair","2024-01-15",{"date":143,"type":36},"2024-01-17",{"date":145,"type":36},"2023-12-24",{"date":147,"type":21},"2029-04-30",{"name":103,"class":73},5,{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":81,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":5},"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":53,"type":21},[84],"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.",[87,28,161],"Epstein-Barr Virus-Associated Gastric Carcinoma",[90,91,92,94,163],"Epstein-Barr Virus-associated gastric cancer","2023-07-25",{"date":166,"type":36},"2023-08-01",{"date":168,"type":21},"2023-07-28",{"date":170,"type":21},"2029-07-28",{"name":103,"class":73},{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":81,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":5},"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":112,"type":21},[84],"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",[87,28,183],"Mismatch Repair Deficiency",[90,91,92,94],"2023-07-24",{"date":164,"type":36},{"date":188,"type":36},"2023-05-31",{"date":190,"type":21},"2029-02-28",{"name":103,"class":73},{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":203,"conditions":204,"keywords":205,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":44},"100478091","phase-2-neoadjuvant-immunotherapy-and-chemoradiotherapy-for-locally-advanced-esophagogastric-junction-adenocarcinoma-100478091","NCT05505461","Neoadjuvant Immunotherapy and Chemoradiotherapy for Locally Advanced Esophagogastric Junction Adenocarcinoma","Efficacy and Safety of PD-1 Combined With Long-term Concurrent Neoadjuvant Chemoradiotherapy and Chemotherapy in the Treatment of Resectable Locally Advanced Esophagogastric Junction Adenocarcinoma： A Phase II Study","NICLA","Inclusion Criteria:\n\n1. Histologically confirmed adenocarcinoma of esophagogastric junction, and Her-2 negative.\n2. Clinically diagnosed stage T3+orN+M0, according to CT\u002FMRI scan.\n3. No prior anti-tumor treatment, including surgery, chemotherapy, radiotherapy, and targeted therapy.\n4. Eastern Cooperative Oncology Group(ECOG) performance status(PS) 0-1.\n5. At least one evaluable lesion in abdominal CT\u002FMRI according to RESIST 1.1 is required.\n6. Expected survival ≥6 months.\n7. Adequate organ function, Hemoglobin ≥90g\u002FL; White blood cells ≥3.0×109\u002FL; neutrophil count ≥1.5×109\u002FL; Platelets ≥100×109\u002FL; Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance rate ≥ 50ml\u002Fmin (Cockcroft-Gault formula); Total bilirubin (TBIL) ≤ 1.5 times the ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 2.5 times the ULN; Urine protein \\\u003C 2+; if urine protein ≥ 2+, 24-hour urine protein quantification shows that protein must be ≤ 1 g.\n8. Normal coagulation function, no active bleeding and thrombotic diseases: International Standardized Ratio INR≤1.5×ULN; Partial thromboplastin time APTT≤1.5×ULN; Prothrombin time PT≤1.5ULN;\n9. Previous use of anti-tumor Chinese medicines, proprietary Chinese medicines, and immunomodulators (such as thymosin, interleukin, etc.) must be ≥ 2 weeks from the start of the study medication;\n10. Female patients should not be pregnant or breast feeding. Male should contraception.\n11. Able and willing to give informed consent to participate.\n12. Those who are expected to have good compliance.\n\nExclusion Criteria:\n\n1. Existence of other active malignant tumors within 5 years or at the same time.\n2. Already received chemotherapy, radiation therapy, targeted or immunotherapy.\n3. Have any active autoimmune disease or history of autoimmune disease.\n4. Patients with congenital or acquired immunodeficiency.\n5. Use of immunosuppressive drugs within 14 days before the study start.\n6. Administer live attenuated vaccines within 4 weeks before the study start.\n7. Suffering from uncontrolled cardiac clinical symptoms or diseases, such as (1) NYHA II and above heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) poorly controlled arrhythmia.\n8. Patients with past and current interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, etc., and severely impaired lung function.\n9. Suffering from active pulmonary tuberculosis.\n10. Complicated severe infection within 4 weeks before the the study start, or unexplained fever \\>38.5°C during the screening period\u002Fbefore the study start.\n11. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n\n13\\. Allergic to any drug in this study. 14. Combined with other severe, acute and chronic diseases that may increase the risk of participating.\n\n15.Participators who had been recruited by other clinical trial within three months.",{"count":201,"type":21},26,[84],"The purpose of this study was to evaluate the effect and safety of concurrent PD-1 antibody-based long-term radiotherapy followed by 2 cycles SOX with PD-1 in patients with locally advanced adenocarcinoma of esophagogastric junction.",[28],[206],"PD-1, neoadjuvant therapy, radiotherapy","2022-08-15",{"date":209,"type":36},"2022-08-17",{"date":211,"type":21},"2023-01",{"date":213,"type":21},"2027-12",{"name":215,"class":73},"Peking University People's Hospital"]