[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632587":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":24,"overallStatus":65,"whyStopped":24,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":24},{"fullName":5,"class":6},"Fudan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Sintilimab, bevacizumab and chemotherapy (XELOX\u002FSOX)","EXPERIMENTAL","Sintilimab: 200mg, ivdrip, d1, q3w; Bevacizumab:7.5mg\u002Fkg，iv drip，d1, q3w; XELOX:Oxaliplatin+ Capecitabine Capecitabine: 1000mg\u002Fm2 twice daily, d1-14, q3w Oxaliplatin: 130mg\u002Fm2, ivdrip,d1, q3w; SOX: Oxaliplatin+S-1 S-1:40\\~60mg Bid, d1\\~14, q3w Oxaliplatin: 130mg\u002Fm2, ivdrip,d1, q3w;",[13,14,15,16,17],"Drug: Sintilimab","Drug: Bevacizumab","Drug: Oxaliplatin","Drug: Capecitabine","Drug: S-1",[19,25,29,33,37],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Sintilimab","Sintilimab, recombinant humanized anti-PD-1 monoclonal antibody for injection; 200mg iv drip，d1, q3w",[9],null,{"type":20,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Bevacizumab","7.5mg\u002Fkg，iv drip，d1, 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},"Capecitabine","1000mg\u002Fm2 twice daily, d1-14, q3w",[9],{"type":20,"name":38,"description":39,"armGroupLabels":40,"otherNames":24},"S-1","40\\~60mg Bid，d1\\~14, q3w",[9],{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Fenglin Liu","MD","100632587","phase-2-efficacy-of-sintilimab-combined-with-bevacizumab-and-xeloxsox-in-initially-unresectable-afp-positive-gastricgastroesophageal-junction-adenocarcinoma-100632587",false,"NCT07515625","Efficacy of Sintilimab Combined With Bevacizumab and XELOX\u002FSOX in Initially Unresectable AFP-positive Gastric\u002FGastroesophageal Junction Adenocarcinoma","Conversion Therapy of Sintilimab Combined With Bevacizumab and XELOX\u002FSOX for Initially Unresectable AFP-positive Gastric\u002FEsophagogastric Junction Adenocarcinoma : A Multi-center, Single-arm, Phase II Trial (SOLIDS-02)","Inclusion Criteria:\n\n* Signed informed consent;\n* Patients age 18-75 years;\n* Histologically CT\u002FMRI confirmed cT3-4N+M0\u002F1 gastric or GEJ adenocarcinoma; (M1 only includes type I liver metastasis of gastric cancer, according to the \"Chinese Expert Consensus on Liver Metastasis of Gastric Cancer\");\n* Serum AFP levels \\> 2× upper limit of normal or AFP-positive by IHC staining;\n* Adequate organ function\n* ECOG 0-1, no surgery contraindications;\n* Expected survival ≥3 months;\n\nExclusion Criteria:\n\n* HER2-positive status: IHC 3+, or IHC 2+\u002FFISH+\n* Prior chemotherapy, radiotherapy, anti-PD-1\u002FPD-L1 therapy, surgery for gastric cancer;\n* Signs of other distant metastases (e.g., peritoneal, lung, bone, supraclavicular lymph, etc.)\n* Significant cardiovascular disease\n\n  --Current treatment with anti-viral therapy or HBV\n* Pregnancy or breastfeeding\n* History of malignancy within 5 years prior to screening\n* Present or history of any autoimmune disease or immune deficiency;\n* There are active gastric and duodenal ulcers, ulcerative colitis and other gastrointestinal diseases, or active bleeding in unresectable tumors.","ALL","18 Years","75 Years",{"count":56,"type":57},46,"ESTIMATED","INTERVENTIONAL",[60],"PHASE2","Alpha-fetoprotein-producing gastric cancer (AFP-positive gastric cancer, AFP-GC), a rare and highly aggressive subtype of gastric cancer, accounts for 1.3% to 15% of all gastric cancer cases. Its clinical features are significantly different from those of common gastric cancer. Not only does it show abnormally elevated serum AFP levels, but it also has a stronger angiogenic ability, a higher rate of distant metastasis, and a poorer prognosis even after a upfront R0 surgery, making it a challenging problem in the field of gastric cancer treatment. Notably, patients with AFP-positive gastric cancer have a relatively low sensitivity to the traditional standard regimens. There is an urgent need to explore targeted treatment strategies to break through the efficacy bottleneck.\n\nCombination of sintilimab, bevacizumab and XELOX\u002FSOX for initially unresectable AFP-positive gastric\u002Fesophagogastric junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. This study is a multi-center, single-arm phase 2 clinical trial to evaluate efficacy, tolerability and safety of perioperative sintilimab in combination with bevacizumab and XELOX\u002FSOX in initially unresectable AFP-positive gastric\u002Fesophagogastric junction adenocarcinoma.",[63,64],"Gastric Cancer (GC)","AFP Gastric or Gastroesophageal Junction Adenocarcinoma","NOT_YET_RECRUITING","2026-03-30",{"date":68,"type":69},"2026-04-07","ACTUAL",{"date":71,"type":57},"2026-04-01",{"date":73,"type":57},"2029-04-01",{"name":5,"class":6}]