[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586385":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":24,"locations":24,"responsibleParty":41,"collaborators":24,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":24,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":24,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":69,"whyStopped":24,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":24},{"fullName":5,"class":6},"Fudan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Tislelizumab plus SOX and HIPEC","EXPERIMENTAL","Tislelizumab, chemotherapy (SOX), and HIPEC(Docetaxel or paclitaxel)",[13,14,15,16,17],"Drug: Tislelizumab","Drug: S-1","Drug: Oxaliplatin","Drug: Docetaxel","Drug: Paclitaxel",[19,25,29,33,37],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Tislelizumab","recombinant humanized anti-PD-1 monoclonal antibody for injection; 200mg ivdrip，d1, q3w",[9],null,{"type":20,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"S-1","40\\~60mg Bid，d1\\~14, q3w",[9],{"type":20,"name":30,"description":31,"armGroupLabels":32,"otherNames":24},"Oxaliplatin","130mg\u002Fm2，iv drip for 2h，d1, q3w",[9],{"type":20,"name":34,"description":35,"armGroupLabels":36,"otherNames":24},"Docetaxel","Docetaxel at a dose of 20 mg\u002Fm2 or paclitaxel at a dose of 40 mg\u002Fm2 dissolved in 3-5 L of normal saline heated to 43 ± 0.5 °C for HIPEC.(d01-d03,qd,before first cycle of Tislelizumab and SOX)",[9],{"type":20,"name":38,"description":39,"armGroupLabels":40,"otherNames":24},"Paclitaxel","Paclitaxel at a dose of 40 mg\u002Fm2 or docetaxel at a dose of 20 mg\u002Fm2 dissolved in 3-5 L of normal saline heated to 43 ± 0.5 °C for HIPEC.(d01-d03,qd,before first cycle of Tislelizumab and SOX)",[9],{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Fenglin Liu","MD PhD","100586385","phase-2-efficacy-of-tirellizumab-combined-with-oral-intravenous-and-abdominal-chemotherapy-in-peritoneal-metastatic-gastricgastroesophageal-junction-adenocarcinoma-100586385",false,"NCT06914687","Efficacy of Tirellizumab Combined With Oral, Intravenous and Abdominal Chemotherapy in Peritoneal Metastatic Gastric\u002FGastroesophageal Junction Adenocarcinoma","Tirellizumab Combined With SOX and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Peritoneal Metastatic Gastric\u002FGastroesophageal Junction Adenocarcinoma: A Single-arm, Phase II Clinical Trial (Solids-03)","Inclusion Criteria:\n\nSigned informed consent Patients age 18-75 years Histologically CT\u002FMRI confirmed cT3-4NanyM1 gastric or GEJ adenocarcinoma; Peritoneal metastasis was confirmed by laparoscopy (with or without Krukenberg tumor ) The degree of peritoneal metastasis ≤P1b or PCI≤13 points ECOG 0-1, no surgery contraindications; Expected survival ≥3 months;\n\nExclusion Criteria:\n\nPrior chemotherapy, radiotherapy, surgery for gastric cancer; Signs of other distant metastases (e.g., liver, lung, bone, supraclavicular lymph, etc.) Significant cardiovascular disease Major surgical procedure within 4 weeks prior to initiation of study treatment Current treatment with anti-viral therapy or HBV Pregnancy or breastfeeding History of malignancy within 5 years prior to screening Present or history of any autoimmune disease or immune deficiency Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent There are active gastric and duodenal ulcers, ulcerative colitis and other gastrointestinal diseases, or active bleeding in unresectable tumors Poorly controlled hypertension or diabetes","ALL","18 Years","75 Years",{"count":56,"type":57},30,"ESTIMATED","INTERVENTIONAL",[60],"PHASE2","For peritoneal metastatic gastric\u002Fgastroesophageal junction adenocarcinoma (cT3-4NanyM1), PD-1 antibody combined with chemotherapy and hyperthermic intraperitoneal chemotherapy (HIPEC) can downstage tumor stage, increase the conversion resection rate, and may improve the long-term survival. Tislelizumab, an anti-PD-1 antibody, has recently been proved in the first- and second-line standard treatment for advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma.In the subgroup analysis of RATIONALE-305 trial, tislelizumab also showed good efficacy in gastric\u002Fgastroesophageal junction adenocarcinoma patients with peritoneal metastasis. Combination of tirellizumab,SOX and HIPEC for peritoneal metastatic gastric\u002Fgastroesophageal junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. This study is a monocenter, single-arm phase 2 clinical trial to evaluate tolerability, safety and efficacy of perioperative tirellizumab in combination with SOX and HIPEC in peritoneal metastatic gastric\u002Fgastroesophageal junction adenocarcinoma.",[63,64,65],"Gastric Adenocarcinoma","Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma","Peritoneal Metastasis",[67,65,68],"gastric cancer","Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma","NOT_YET_RECRUITING","2025-03-31",{"date":72,"type":73},"2025-04-06","ACTUAL",{"date":75,"type":57},"2025-03-30",{"date":77,"type":57},"2028-04-01",{"name":5,"class":6}]