[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xiangdong Cheng\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":175},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,41,67,88,112,133,155],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100598209","phase-3-perioperative-tislelizumab-plus-chemotherapy-versus-chemotherapy-alone-in-mhc-ii-positive-gastricgej-cancer-100598209",false,"NCT07068516","Perioperative Tislelizumab Plus Chemotherapy Versus Chemotherapy Alone in MHC-II-Positive Gastric\u002FGEJ Cancer","A Multicenter, Randomized, Double-blind, Phase III Clinical Trial of Tislelizumab Combined With Chemotherapy Versus Placebo Plus Chemotherapy as Perioperative Treatment for MHC Class II-positive Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Willingness to participate and signed informed consent form\n* ≥18 years old\n* Histologically confirmed gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma\n* MHC-II immunohistochemistry (IHC) 2+\u002F3+\n* Locally advanced disease (cT3-4a, N+, M0) confirmed by CT and\u002For diagnostic laparoscopy (AJCC 8th edition)\n* No previous anticancer therapy (surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.)\n* Scheduled to undergo curative resection after neoadjuvant therapy\n* Ability to swallow oral medication\n* ECOG performance status 0-1\n* Estimated survival ≥6 months\n* Hematological (without transfusion\u002FG-CSF support within 14 days):ANC ≥1.5×10⁹\u002F, Platelets ≥80×10⁹\u002FL, Hemoglobin ≥80 g\u002FL. Hepatic\u002FRenal: Total bilirubin \\\u003C1.5×ULN, ALT\u002FAST ≤2.5×ULN, Serum creatinine ≤1.5×ULN or CrCl \\>50 mL\u002Fmin (calculated by Cockcroft-Gault formula: Male: CrCl = \\[(140-age) × weight (kg)\\] \u002F (72 × serum Cr \\[mg\u002FdL\\]), Female: CrCl = \\[(140-age) × weight (kg)\\] \u002F (72 × serum Cr \\[mg\u002FdL\\]) × 0.85.\n* Contraception Requirements: Female participants of childbearing potential: Negative serum pregnancy test within 7 days before enrollment; agreement to use highly effective contraception during treatment and for 120 days after last dose. Female participants of childbearing potential: Negative serum pregnancy test within 7 days before enrollment; agreement to use highly effective contraception during treatment and for 120 days after last dose.\n\nExclusion Criteria:\n\n* Tumors deemed unresectable due to disease extent, surgical contraindications, or patient refusal.\n* Known microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) tumors.\n* History of or concurrent other malignancies (except adequately treated non-melanoma skin cancer or carcinoma in situ).\n* Chronic or clinically significant conditions that may compromise treatment tolerance (e.g., severe cardiac disease, uncontrolled hypertension, significant hepatic\u002Frenal dysfunction).\n* History of gastrointestinal perforation, intra-abdominal abscess, or bowel obstruction within 3 months (or clinical\u002Fradiologic suspicion of obstruction).\n* Presence of active ulcers, non-healing wounds, or fractures.\n* Arterial\u002Fvenous thrombosis within 6 months (e.g., stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism).\n* Urinalysis showing ≥++ protein with confirmed 24-hour urine protein \\>1.0 g.\n* Requiring systemic antibiotics, antivirals, or antifungals.\n* Hepatitis B: HBsAg-positive with HBV DNA ≥500 IU\u002FmL. Hepatitis C: HCV antibody-positive with HCV RNA above ULN.\n* Congenital or acquired (e.g., HIV infection).\n* Active autoimmune disease or history of autoimmune disease with relapse potential.\n* Prior or planned organ\u002Fallogeneic bone marrow transplantation.\n* Interstitial lung disease (ILD), history of steroid-treated ILD, active pneumonia on screening CT, or active tuberculosis.\n* Current or recent use of immunosuppressants or systemic corticosteroids (except physiologic replacement doses).\n* Received live attenuated vaccines within 28 days before treatment or requiring them during\u002Fwithin 60 days post-treatment.\n* Known allergy to any study drug or excipients.\n* Currently breastfeeding.\n* Any condition that, per investigator judgment, may jeopardize patient safety or study completion.","ALL","18 Years","80 Years",{"count":20,"type":21},470,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Investigators has conducted a series of studies on patient selection for perioperative immunotherapy in locally advanced gastric cancer. Results from prospective single-arm trial (NCT05739045) demonstrated that 21.74% of patients achieved pathological complete response (pCR) after receiving neoadjuvant nivolumab combined with SOX regimen. Notably, investigators identified that the sensitive group exhibited upregulated MHC-II expression in malignant cells at baseline, with enriched pathways including interferon-gamma signaling and MHC class II antigen presentation. The pCR rate was significantly higher in MHC-II positive patients compared to MHC-II negative patients (36.84% vs 11.11%, P=0.038). Subsequent retrospective analyses and another prospective single-arm study focusing on MHC-II positive populations consistently showed superior short-term treatment outcomes with immunotherapy plus chemotherapy in this subgroup.\n\nBuilding upon these preliminary findings from small-scale studies and considering current developments in the field, we are now initiating this multicenter, randomized, double-blind, placebo-controlled phase III clinical trial. The study aims to evaluate the efficacy and safety of tislelizumab combined with chemotherapy versus placebo plus chemotherapy as perioperative treatment for MHC-II positive patients with locally advanced gastric or gastroesophageal junction adenocarcinoma.",[27],"Gastric Cancer Stage","NOT_YET_RECRUITING","2025-07-06",{"date":31,"type":32},"2025-07-16","ACTUAL",{"date":34,"type":21},"2025-07-20",{"date":36,"type":21},"2030-06-30",{"name":38,"class":39},"Xiangdong Cheng","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":40},"100574978","phase-1-ql1706-combined-with-sox-used-in-theperioperative-treatment-100574978","NCT06766305","QL1706 Combined With SOX Used in Theperioperative Treatment","Phase Ib\u002FII Clinical Study of QL1706 Combined With SOX Perioperative Treatment for Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Sign a written informed consent to join the study voluntarily;\n2. Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction;\n3. Adenocarcinoma of the stomach or gastroesophageal junction was evaluated by CT\u002FMRI (primary clinical stage ≥T3 or N+, M0, according to AJCC 8th edition staging), including Siewert type II and III tumors\n4. Age 18-75 years old, male or female;\n5. ECOG PS 0-1 ;\n6. Have not received any anti-tumor treatment for gastric or gastroesophageal junction adenocarcinoma, including radiotherapy, chemotherapy, surgery, etc.;\n7. Surgical treatment is planned after the completion of neoadjuvant therapy, and R0 resection is expected;\n8. Expected survival ≥6 months;\n9. Normal functioning of major organs, including:\n\n   1. Blood routine examination (no blood component, cell growth factor are allowed within 7 days before the first use of the study drug) :\n\n      neutrophil count ≥ 1.5×109\u002FL Platelet count ≥ 80×109\u002FL Hemoglobin ≥ 80 g\u002FL\n   2. Blood biochemical examination:\n\n      Total bilirubin ≤ 1.5 x ULN ALT ≤ 2.5 x ULN, AST ≤ 2.5 x ULN, Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 50 mL\u002Fmin (Cocheroft-Gault formula)\n   3. Coagulation function:\n\n   International Standardized ratio (INR) ≤ 1.5 x ULN Activated partial thromboplastin time (APTT) ≤ 1.5 x ULN\n10. Fertile female subjects are required to take a serum or urine pregnancy test that is negative within 72 hours prior to the start of the study drug administration, and to use effective contraception (such as Iuds, contraceptives, or condoms) during the trial period and for at least 120 days after the last dose; For male subjects whose partner is a fertile woman, they should be surgically sterilized or agree to use effective contraception during the trial and for 120 days after the last dose;\n11. The subject have good compliance and cooperated well with the follow-up\n12. Agreed to provide tumor tissue samples\n\nExclusion Criteria:\n\n1. There are unresectable factors, including unresectable tumor causes or unresectable or refused surgery contraindications;\n2. Have received or are receiving any of the following treatment:\n\n   1. any radiation therapy, chemotherapy, or immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.) and other anti-tumor drugs;\n   2. being treated with immunosuppressive drugs or systemic hormones for immunosuppressive purposes within 2 weeks prior to the initial use of the investigational drug (dose \\>10mg\u002F day prednisone or equivalent); In the absence of active autoimmune disease, inhaled or topical steroid use and adrenocortical hormone replacement with doses \\>10mg\u002F day of prednisone or equivalent are permitted;\n   3. Received live attenuated vaccine within 4 weeks prior to the first use of the investigational drug; If enrolled, subjects must not receive live vaccine during the study period or within 120 days after the last administration of QL1706;\n3. Serious infections (CTCAE \\> Grade 2) occurred within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, and infection complications requiring hospitalization; Baseline chest imaging indicated active pulmonary inflammation, signs and symptoms of infection within 14 days prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, except in cases of prophylactic antibiotic use;\n4. Patients with active autoimmune disease requiring systemic treatment within 2 years prior to initial use of the investigational drug or a history of autoimmune disease with recurrence possible \\[including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (which can be controlled by hormone replacement therapy alone) Patients can be enrolled)\\];\n5. A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation;\n6. There are clinical symptoms or diseases of heart that are not well controlled, including but not limited to: (1) NYHA grade II or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) Clinically significant supraventricular or ventricular arrhythmias that are not well controlled without or after clinical intervention; (5) QTc\\> 450ms (male); QTc \\> 470ms (female);\n7. Patients found to have active pulmonary tuberculosis infection through medical history or CT examination, or had a history of active pulmonary tuberculosis infection within 1 year before enrollment, or had a history of active pulmonary tuberculosis infection more than 1 year ago without formal treatment;\n8. There are factors that increase the risk of prolonged QTc and abnormal heart rate, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, sudden unexplained death of immediate family members under 40 years of age, or prolonged QT interval accompanied by medication;\n9. Active hepatitis (Hepatitis B reference: HBsAg positive and HBV DNA≥2000 IU\u002Fml; Hepatitis C reference: HCV antibody positive and HCV copy number \\> upper limit of normal);\n10. Defined as ≥ grade 2 peripheral neuropathy according to NCI-CTCAE v5.0 standards;\n11. Have been diagnosed with other malignancies within 5 years prior to initial dosing, unless malignancies with a low risk of metastasis or death (5-year survival \\> 90%), such as well-treated basal cell or squamous cell skin cancer of the skin or cervical carcinoma in situ may be considered for inclusion;\n12. Known history of severe hypersensitivity to other monoclonal antibodies; Patients with a known history of allergy or hypersensitivity to QL1706, oxaliplatin, and Tigor or any of their components;\n13. Known deficiency of dihydropyrimidine dehydrogenase;\n14. Upper gastrointestinal obstruction or abnormal physiological function or malabsorption syndrome that may affect the absorption of Tegor;\n15. Pregnant or lactating women;\n16. Enrolling in another clinical study at the same time, unless it is an observational, non-interventional clinical study or the follow-up period of an interventional study;\n17. The investigator determined that there were other factors that might have led to the forced termination of the study, such as other serious medical conditions (including mental illness) requiring co-treatment, alcohol, substance abuse, family or social factors, and factors that might have affected the safety or adhere","75 Years",{"count":50,"type":21},54,[52,53],"PHASE1","PHASE2","This is a single-center, single-arm clinical study to evaluate the efficacy and safety of QL1706 combined with SOX for the treatment of resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.\n\nThe study consists of the following two phases:\n\nPhase 1: The safety introduction phase of QL1706 combined with SOX, using a 3+3 design, enrolled about 6 to 12 patients with locally advanced gastric\u002Fgastroesophageal junction adenocarcinoma (primary clinical stage ≥T3 or N+, M0) and underwent 3-week DLT evaluation.\n\nPhase 2: This phase plans to enroll 42 to 45 patients, using investigator-evaluated pCR as the primary endpoint. QL1706 is administered by intravenous infusion of RP2D as defined in Part 1 starting from cycle 1.\n\nPreoperative QL1706 RP2D combined with SOX (3 cycles) → radical surgery (D2) → postoperative QL1706 RP2D combined with SOX (5 cycles) → postoperative maintenance of QL1706 RP2D (up to 1 year before and after surgery); neoadjuvant therapy Surgery should be performed within 3 to 6 weeks after the last dosing, with a minimum interval of 4 weeks after surgery and a maximum interval of 6 weeks recommended for postoperative adjuvant therapy.",[56,57],"Gastric Cancers","Esophagogastric Junction Cancers","RECRUITING","2025-06-12",{"date":61,"type":32},"2025-06-17",{"date":63,"type":32},"2025-03-21",{"date":65,"type":21},"2031-06-30",{"name":38,"class":39},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":40},"100563025","phase-1-study-of-ibi363-in-patients-with-advanced-first-line-gastric-cancer-100563025","NCT06610799","Study of IBI363 in Patients with Advanced First-line Gastric Cancer","Phase Ib Study to Evaluate the Safety, Tolerability and Efficacy of IBI363 in Combination with Oxaliplatin and Capecitabine (XELOX) in First-line Treatment of Unresectable Advanced or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Male or female subjects, ≥ 18 years and ≤75 years.\n2. Subjects with unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma without prior systematic treatment.\n3. Subjects with at least one measurable lesion according to RECIST v1.1.\n4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.\n5. Expected survival time ≥ 3 months.\n\nExclusion Criteria:\n\n1. Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug.\n2. Active uncontrolled bleeding or a known bleeding diathesis.\n3. Subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.",{"count":75,"type":21},40,[52],"This is a phase 1b study designed to evaluate the safety, tolerability and efficacy of IBI363 in combination with oxaliplatin and capecitabine (XELOX) in first-line treatment of unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma.",[79],"IBI363 + Chemotherapy","2024-11-18",{"date":82,"type":32},"2024-11-20",{"date":84,"type":32},"2024-10-15",{"date":86,"type":21},"2026-12-31",{"name":38,"class":39},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":95,"targetDuration":4,"studyType":97,"phases":4,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":40},"100565490","multi-omics-based-prediction-of-treatment-response-to-immunotherapy-combined-with-chemotherapy-in-advanced-gastricgastroesophageal-junction-cancer-100565490","NCT06642857","Multi-omics Based Prediction of Treatment Response to Immunotherapy Combined with Chemotherapy in Advanced Gastric\u002FGastroesophageal Junction Cancer.","Predicting Treatment Response to Immunotherapy Combined with Chemotherapy in Advanced Gastric\u002Fgastroesophageal Junction Cancer Based on the Multi-omics Information During Tumor Evolution.","Inclusion criteria：\n\n* Patients with gastric or gastroesophageal junction adenocarcinoma confirmed by pathology and with advanced or metastatic disease that cannot be resected\n* HER2 negative\n* Not received any anti-tumor treatment before.\n* After evaluation, the treatment plan is chemotherapy combined with immunotherapy.\n* Aged 18 to 75 years old, gender is not limited.\n* Expected survival time is greater than or equal to 3 months. Exclusion criteria：\n* Patients with malignant tumors other than gastric cancer or those with tumors metastasized to the stomach from other sites.\n* Patients who have previously received anti-tumor treatments such as surgery, radiotherapy and chemotherapy, targeted therapy or immunotherapy.\n* Patients with severe infections.\n* Those with a history of mental illness cannot cooperate with the research.\n* Patients with severe heart, liver, kidney and other diseases.\n* Pregnant or lactating patients.\n* HER2 positive.",{"count":96,"type":21},150,"OBSERVATIONAL","In this project, based on the information of advanced gastric\u002Fgastroesophageal junction cancer in evolution under immunotherapy combined with chemotherapy treatment, we will integrate multi-omics dynamic data to identify essential features that correlate to therapeutic effects of immunotherapy therapy, screen potential molecular markers\u002Fdominant microbiota for predicting the efficacy of immunotherapy and establish a multimodal predictive model for patients that benefit from immunotherapy. Our project could provide evidence to predict response to immunotherapy for patients with advanced gastric\u002Fgastroesophageal junction cancer and potentially optimize the clinical decision-making about therapy for advanced gastric\u002Fgastroesophageal junction cancer.",[100,101],"Advanced Gastric Carcinoma","Advanced Gastroesophageal Junction Adenocarcinoma",[100,101,103,104],"Chemotherapy combined with immunotherapy","efficacy prediction","2024-10-14",{"date":84,"type":32},{"date":108,"type":32},"2024-03-25",{"date":110,"type":21},"2026-02-01",{"name":38,"class":39},{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":118,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":119,"targetDuration":4,"studyType":97,"phases":4,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},"100563285","a-pan-cancer-screening-and-diagnosis-model-based-on-abdominal-ct-was-established-100563285","NCT06614179","A Pan-cancer Screening and Diagnosis Model Based on Abdominal CT Was Established","Inclusion Criteria:\n\n* Patients with abdominal tumors:\n* all patients were pathologically diagnosed with abdominal tumors;\n* The clinical case data of all patients were complete, and complete follow-up was obtained, with clear information on medical visits, operation time and survival status within 2 years. If the cause of death is unknown, it will be recorded as censored data;\n* All patients had no history of active abdominal bleeding, no serious infection or other abdominal diseases that affected the observation of CT imaging within 3 months before surgery.\n* Non-tumor population:\n* all patients have complete clinical case data, complete abdominal CT, no history of malignant tumors, no serious infections or other abdominal diseases that affect the diagnosis and observation of CT imaging.\n\nExclusion Criteria:\n\n* Cases in which contrast-enhanced or noncontrast CT images show unclear lesions, with significant noise and artifacts;",true,{"count":120,"type":21},100000,"Abdominal noncontrast scan and contrast-enhanced CT were used to establish a screening and diagnostic model for abdominal tumors",[123],"Abdominal Neoplasm","2024-09-25",{"date":126,"type":32},"2024-09-26",{"date":128,"type":32},"2024-07-01",{"date":130,"type":21},"2029-12-31",{"name":38,"class":39},2,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":40},"100496041","phase-2-nivolumab-combined-with-sox-used-in-the-perioperative-treatment-100496041","NCT05739045","Nivolumab Combined With SOX Used in the Perioperative Treatment","A Multicenter, Prospective, Phase Ⅱ Clinical Study of Nivolumab Combined With SOX in the Perioperative Treatment of Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\nPatients must meet all of the following inclusion criteria to be enrolled in the study:\n\n1\\. Patients voluntarily participate in the study and sign the informed consent form; 2. Age ≥ 18 years and ≤ 75 years; 3. Have pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; 4. Patients with gastric or gastroesophageal junction adenocarcinoma at the clinical staging of cT3-4 or N+, M0 (staging according to AJCC version 8) who could be radically resected as determined by CT and laparoscopy; 5. Have not received anti-tumor therapy (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 6. Planned surgical treatment after completion of neoadjuvant therapy; 7. Able to swallow tablets normally; 8. ECOG score 0-1; 9. Expected survival \\>=12 months; 10. Main organ functions normal, i.e., meeting the criteria below:\n\n1. Blood routine examination criteria shall meet:\n\n   (No blood transfusion or blood products within 14 days, no G-CSF or other hematopoietic stimulating factors are used for correction) Absolute neutrophil count ≥1.5×109\u002FL; Platelet ≥80×109\u002FL; Hemoglobin ≥ 80 g\u002FL\n2. Criteria for biochemical tests:\n\nTotal bilirubin \\\u003C1.5×ULN; ALT and AST≤2.5×ULN;\n\nSerum Cr ≤ 1.5 × ULN or endogenous creatinine clearance \\> 50 ml\u002Fmin (males: Endogenous creatinine clearance rate = ((140-age) × body weight)\u002F(72 × serum Cr); female: endogenous creatinine clearance rate = ((140-age) × body weight)\u002F(72 × serum Cr) × 0.85; body weight unit: kg; serum Cr unit: mg\u002FmL):\n\n11\\. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and be willing to use a highly effective method of contraception during the trial and for 120 days after the last dose. Male subjects with partners of childbearing potential should be surgically sterilized or agree to use highly effective methods of contraception during the trial and for 120 days after the last dose;\n\nExclusion Criteria:\n\nPatients with any of the following are not to be enrolled in the study:\n\n1. Patients with unresectable factors, including unresectable tumor causes or unresectable surgical contraindications or refusal of surgery;\n2. Previous or concurrent other malignancy;\n3. Suffering from any chronic or major illness considered intolerable to treatment (eg, severe cardiac disease, uncontrolled hypertension, some degree of hepatic or renal dysfunction, etc.)\n4. Patients who have previous gastrointestinal perforation, abdominal abscess or recent (within 3 months) intestinal obstruction or imaging and clinical symptoms suggestive of intestinal obstruction;\n5. Patients having clinically significant bleeding symptoms or definite bleeding tendency within 3 months before the first dose of study drug, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or suffering from vasculitis; if stool occult blood is positive at baseline, reexamination may be performed; if stool occult blood remains positive after reexamination, gastroscopy is required (except for patients having gastroscopy within 3 months before enrollment to exclude such condition);\n6. Patients in the active stage of infection requiring treatment (such as antibacterial drugs, antiviral drugs, antifungal drugs);\n7. Active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA ≥ 500 IU\u002Fml; hepatitis C reference: HCV antibody positive and HCV viral copy number \\> upper limit of normal);\n8. Patients with congenital or acquired immunodeficiency (such as HIV infection);\n9. Patients with any active autoimmune disease or history of autoimmune disease with potential relapse;\n10. Planned or previous organ or allogeneic bone marrow transplant;\n11. Patients with current interstitial pneumonia or interstitial lung disease, or previous history of interstitial pneumonia or interstitial lung disease requiring steroids, or subjects with active pneumonia or severe lung function impairment on screening CT; active pulmonary tuberculosis;\n12. Ongoing or recent treatment with immunosuppressive drugs or systemic corticosteroids to achieve immunosuppression;\n13. Patients who have received a live attenuated vaccine within 28 days prior to the first dose of study drug or who require administration of such vaccine during treatment or within 60 days after the last dose;\n14. Patients with known hypersensitivity to any of the study drugs or any of their excipients;\n15. Nursing mothers;\n16. Any factors that, in the judgment of the investigator, could affect patient safety and force the termination of the study",{"count":141,"type":21},46,[53],"To evaluate the pathological complete response rate (pCR) of nivolumab combined with SOX (oxaliplatin + S-1) for neoadjuvant therapy of resectable gastric and gastroesophageal junction adenocarcinoma;",[145,146],"Immune Suppression","Gastric Cancer","2024-07-07",{"date":149,"type":32},"2024-07-09",{"date":151,"type":32},"2022-11-03",{"date":153,"type":21},"2024-12-31",{"name":38,"class":39},{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":40},"100544900","phase-2-tislelizumab-combined-with-neoadjuvant-chemotherapy-used-in-the-perioperative-treatment-100544900","NCT06374901","Tislelizumab Combined With Neoadjuvant Chemotherapy Used in the Perioperative Treatment.","A Multicenter, Prospective Phase II Clinical Study of Tislelizumab in Combination With Chemotherapy for the Perioperative Treatment of Resectable Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* The patient voluntarily joined this study and signed an informed consent form;\n* Age ≥ 18 years old, ≤ 75 years old\n* Pathological diagnosis of gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction\n* Patients must be able to provide fresh slices of tumor tissue (FFPE tissue blocks or approximately 15 slides), unstained FFPE slides, and if clinically feasible, fresh biopsy samples will be preferred. If archived samples cannot be obtained, fresh tumor biopsy specimens must be collected during the baseline period, with the same requirements for glass slides as archived tumor tissue\n* Clinical staging determined by CT and laparoscopy for curative resection is cT3\\~4aN+M0 or cT4bNanyM0 for gastric and gastroesophageal junction adenocarcinoma patients (according to AJCC 8th edition staging)\n* Have not received anti-tumor treatment (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.)\n* Plan to undergo surgical treatment after the completion of neoadjuvant therapy\n* Able to swallow pills normally\n* ECOG score 0-1 points\n* Expected survival time ≥ 12 months\n* Normal function of major organs, i.e. meeting the following criteria:The standard for blood routine examination must comply with: (No blood transfusion or blood products within 14 days, no correction using G-CSF or other hematopoietic stimulating factors)，Neutrophil absolute count ≥ 1.5 × 109\u002FL; Platelets ≥ 80 × 109\u002FL; Hemoglobin ≥ 80g\u002FL\n* Biochemical examination must meet the following standards: Total bilirubin\\\u003C1.5\n\n  * ULN; ALT and AST ≤ 2.5 × ULN; Serum Cr ≤ 1.5 x ULN or endogenous creatinine clearance rate\\>50ml\u002Fmin (male: endogenous creatinine clearance rate=(140 age) x body weight)\u002F(72 x serum Cr); Female: Endogenous creatinine clearance rate=(140 age) x body weight\u002F(72 x serum Cr) x 0.85; Weight unit: kg; Serum Cr unit: mg\u002FmL\n* Female subjects with pregnancy ability must undergo a serum pregnancy test within 7 days before the first medication, and the result is negative. They are willing to use efficient contraception methods during the trial period and 120 days after the last dose. For male subjects whose partners are women of childbearing age, surgical sterilization or agreement to use efficient methods of contraception during the trial period and 120 days after the last dose should be considered\n\nExclusion Criteria:\n\n* There are non resectable factors, including tumor reasons that cannot be resected or surgical contraindications that cannot be resected or those who refuse surgery\n* Previously or currently suffering from other malignant tumors\n* Suffering from any chronic or major illness that is considered intolerable to treatment (such as severe heart disease, uncontrolled hypertension, certain degrees of liver and kidney dysfunction, etc.)\n* Those who have experienced gastrointestinal perforation, abdominal abscess in the past, or recent (within 3 months) intestinal obstruction or imaging and clinical symptoms indicating accompanying intestinal obstruction\n* If there are significant clinically significant bleeding symptoms or clear bleeding tendencies, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis, within the first 3 months prior to the first use of the study drug, and if fecal occult blood is positive during the baseline period, a follow-up examination can be conducted. If the results are still positive after the follow- up examination, a gastroscopy examination is required (excluding those who have undergone gastroscopy examination within 3 months prior to enrollment to exclude such situations)\n* If the patient is in the active infection stage and needs treatment (such as using antibiotics, antiviral drugs, or antifungal drugs)\n* Active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA ≥ 500 IU\u002Fml; hepatitis C reference: HCV antibody positive and HCV copy number\\>upper limit of normal value)\n* Patients with congenital or acquired immune dysfunction (such as HIV infected individuals)\n* Patients with any active autoimmune diseases or a history of autoimmune diseases with the possibility of recurrence\n* Planned or previously received organ or allogeneic bone marrow transplantation\n* Subjects who currently have interstitial pneumonia or interstitial lung disease, or have a history of requiring hormone therapy for interstitial pneumonia or interstitial lung disease, or those whose screening period CT shows active pneumonia or severe lung function impairment; Active pulmonary tuberculosis\n* Current or recent use of immunosuppressive drugs or systemic corticosteroids for the purpose of achieving immunosuppression\n* Patients who have received attenuated live vaccines within 28 days prior to the first use of the study drug, or who need to receive such vaccines during treatment or within 60 days after the last dose\n* Known to be allergic to any investigational drug or excipient\n* Lactating women\n* Any factors determined by the researcher that may affect patient safety and result in the forced termination of this study midway",{"count":163,"type":21},134,[53],"To evaluate the efficacy of Tislelizumab in combination with chemotherapy versus chemotherapy in neoadjuvant treatment of patients with MHC-II positive (IHC≥2+) and locally advanced gastric\u002Fgastroesophageal junction adenocarcinoma by evaluating the main pathologic response rate (MPR).",[146],"2024-04-17",{"date":169,"type":32},"2024-04-19",{"date":171,"type":21},"2024-04-25",{"date":173,"type":21},"2028-03-31",{"name":38,"class":39},""]