[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613395":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":41,"locations":27,"responsibleParty":47,"collaborators":27,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":27,"enrollmentInfo":60,"targetDuration":27,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":27,"overallStatus":72,"whyStopped":27,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":27},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1","EXPERIMENTAL","Participants assigned to arm 1 will receive neoadjuvant adebrelimab 1200 mg intravenously on day 1 combined with XELOX (capecitabine 1000 mg\u002Fm² orally twice daily on days 1-14 plus oxaliplatin 130 mg\u002Fm² intravenously on day 1) for one cycle, followed by adebrelimab monotherapy at the same dose and schedule for three additional cycles. Within 4-6 weeks after completion of the fourth cycle, curative-intent D2 radical gastrectomy will be performed. Post-operative adjuvant systemic therapy-regimen, duration, and number of cycles-will be left to the discretion of the treating investigator, guided by institutional standards and the patient's pathological and clinical status.",[13,14,15],"Drug: Adebrelimab","Drug: XELOX","Procedure: D2 radical gastrectomy",{"label":17,"type":10,"description":18,"interventionNames":19},"Arm 2","Participants in arm 2 will receive neoadjuvant adebrelimab 1200 mg plus SHR-8068 280 mg administered intravenously on day 1 of a 21-day cycle for one cycle, followed by adebrelimab 1200 mg monotherapy on day 1 every 3 weeks for three additional cycles. Curative-intent D2 radical gastrectomy is scheduled 4-6 weeks after completion of the fourth cycle. Any post-operative adjuvant systemic treatment-including regimen, duration, and number of cycles-will be determined at the investigator's discretion according to institutional guidelines and the patient's pathological and clinical status.",[13,20,15],"Drug: SHR-8068",[22,28,32,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Adebrelimab","Participants in both arms will receive neoadjuvant adebrelimab 1200mg intravenously on day 1 of a 21-day cycle for four cycles.",[9,17],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"XELOX","Participants assigned to arm 1 will receive neoadjuvant XELOX (capecitabine 1000 mg\u002Fm² orally twice daily on days 1-14 plus oxaliplatin 130 mg\u002Fm² intravenously on day 1) for one cycle.",[9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"SHR-8068","Participants assigned to arm 2 will receive SHR-8068 280 mg administered intravenously on day 1 for one cycle.",[17],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":27},"PROCEDURE","D2 radical gastrectomy","Curative-intent D2 radical gastrectomy is scheduled 4-6 weeks after completion of the fourth cycle.",[9,17],[42],{"name":43,"role":44,"phone":45,"phoneExt":27,"email":46},"Zhaoqing Tang, PhD, MD","CONTACT","021-64041990","tang.zhaoqing@zs-hospital.sh.cn",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Xuefei.Wang","Chief of Department of Gastrointestinal Surgery","100613395","phase-2-adebrelimab-combined-with-induction-chemotherapy-or-shr-8068-for-mismatch-repair-deficientmicrosatellite-instability-high-dmmrmsi-h-locally-advanced-gastricgastroesophageal-junction-adenocarcinomaa-randomized-non-comparative-phase-2-study-100613395",false,"NCT07266025","Adebrelimab Combined With Induction Chemotherapy or SHR-8068 for Mismatch Repair-Deficient\u002FMicrosatellite Instability-High (dMMR\u002FMSI-H) Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma：A Randomized, Non-comparative Phase 2 Study","CATALIS","Inclusion Criteria:\n\n* Male or female, age ≥ 18 years\n* Pathologically confirmed gastric or gastro-oesophageal-junction adenocarcinoma (Siewert II and III only)\n* dMMR confirmed by IHC or MSI-H confirmed by PCR\n* Investigator-assessed potentially curative resection feasible before study entry\n* CT or MRI clinical stage cT ≥ 2 N any M0 per AJCC 8th edition; laparoscopy with peritoneal washing cytology (and peritoneal biopsy if indicated) recommended to exclude peritoneal metastasis\n* ECOG performance status 0-2\n* Able to swallow tablets\n* Expected survival ≥ 6 months\n* Laboratory values within 7 days before randomisation:\n\nANC \\> 1.5 × 10⁹\u002FL, Hb ≥ 80 g\u002FL, PLT ≥ 75 × 10⁹\u002FL Serum creatinine ≤ 1.5 × ULN or eGFR ≥ 60 mL\u002Fmin\u002F1.73 m² ALT and AST ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN (or TBIL \\> 1.5 × ULN with direct bilirubin ≤ ULN); albumin ≥ 25 g\u002FL INR or PT ≤ 1.5 × ULN and aPTT ≤ 1.5 × ULN (or on anticoagulation within therapeutic range)\n\n* Signed written informed consent; able to comply with protocol visits, treatment, labs, biospecimen collection\n* WOCBP must have negative serum pregnancy test within 72 h before randomisation, not breastfeeding, and use highly effective contraception from screening until 2 months after last adebrelimab\u002FSHR-8068 or 6 months after last chemotherapy, whichever is longer\n* Men with pregnant partners or WOCBP partners must be surgically sterile or use highly effective contraception during study and for same post-treatment periods; no sperm donation allowed\n\nExclusion Criteria:\n\n* Tumour histology squamous-cell, neuro-endocrine, or other non-adenocarcinoma types\n* Unresectable disease (tumour-related or surgical contraindication) or subject refuses surgery\n* Tumour requiring transthoracic surgical approach\n* CNS metastases and\u002For carcinomatous meningitis\n* Prior anti-gastric-cancer therapy (surgery, radiotherapy, chemotherapy, targeted, immunotherapy) except bypass for obstruction\n* Previous malignancy or concurrent malignancy except completely excised basal\u002Fsquamous skin cancer, superficial bladder cancer, or in-situ prostate\u002Fcervix\u002Fbreast cancer disease-free ≥ 5 years\n* Cardiac conditions:\n\nNYHA class \\> II or LVEF \\\u003C 50 % on echo Unstable angina MI within 1 year Resting QTc \\> 450 ms (M) or \\> 470 ms (F) Clinically significant ECG abnormalities, complete LBBB, 3rd-degree AV block, 2nd-degree AV block, PR \\> 250 ms Risk factors for QT prolongation (HF, hypokalaemia, congenital long-QT syndrome, family history of long QT or sudden death \\\u003C 40 y, concomitant QT-prolonging drugs)\n\n* History of GI perforation, intra-abdominal abscess, or bowel obstruction within 3 months or imaging\u002Fclinical signs of obstruction\n* Clinically significant bleeding or bleeding diathesis within 3 months (e.g. GI bleeding, haemorrhagic gastritis, vasculitis); positive faecal occult blood must be endoscopically cleared if still positive on repeat testing (unless gastroscopy within 3 months shows no lesion)\n* Arterial or venous thrombo-embolic event within 6 months (stroke, TIA, intracranial haemorrhage, cerebral infarction)\n* Hypersensitivity to any study-drug component\n* Severe hypersensitivity history to any monoclonal antibody\n* Pregnant or lactating women\n* Positive HIV antibody\n* Active hepatitis (HBsAg positive with HBV DNA ≥ 500 IU\u002FmL; HCV antibody positive with HCV RNA \\> ULN)\n* Prior therapy targeting CTLA-4\u002FPD-1\u002FPD-L1 or other T-cell co-stimulatory\u002Fimmune-checkpoint pathways (including therapeutic vaccines)\n* Active autoimmune disease or autoimmune disease with relapse risk within 2 years (except stable hypothyroidism on replacement or well-controlled type 1 diabetes on insulin)\n* History of idiopathic pulmonary fibrosis, drug-related pneumonia, organising pneumonia (BOOP\u002FCOP), or CT evidence of active pneumonia at screening\n* Live attenuated vaccine within 4 weeks before first study dose or expected need during study\n* Immunodeficiency disorder or chronic systemic corticosteroids or other immunosuppressive therapy within 7 days before first dose (includes prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-TNF agents)\n* Any condition that, in the investigator's opinion, increases study risk, interferes with protocol conduct, or compromises informed consent or compliance","ALL","18 Years",{"count":61,"type":62},30,"ESTIMATED","INTERVENTIONAL",[65],"PHASE2","This is a randomized, non-comparative, open-label, two-arm phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant therapy with adebrelimab plus induction chemotherapy versus adebrelimab plus SHR-8086 in patients with dMMR\u002FMSI-H gastric or gastroesophageal junction adenocarcinoma.",[68,69,70,71],"Gastric Adenocarcinoma","Gastroesophageal Adenocarcinoma","Mismatch Repair Deficient or MSI-High Solid Tumors","Immunotherapy","NOT_YET_RECRUITING","2026-01-24",{"date":75,"type":76},"2026-01-27","ACTUAL",{"date":78,"type":62},"2026-01-30",{"date":80,"type":62},"2030-06-30",{"name":5,"class":6}]