This is a Randomized, Double-Blind, Phase II/III Clinical Study of the Efficacy and Safety of Sintilimab Combined with Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric/Gastroesophageal Junction Adenocarcinoma.
Signed written Informed Consent Form (ICF) and ability to comply with protocol-specified visits and related procedures.
Age ≥ 18 years.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Expected survival ≥ 6 months.
Histologically or cytologically confirmed other pathologic types (e.g., squamous cell carcinoma, sarcoma, undifferentiated carcinoma) or combined gastrointestinal stromal tumor (GIST) before randomization.
Suspicious metastatic lesions or locally advanced unresectable disease, regardless of stage.
History of gastrointestinal perforation or fistula within 6 months before randomization. May be enrolled if perforation/fistula has been surgically treated (repaired/resected) and disease recovery/remission is confirmed by the investigator.
Active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
Parallel
tegafur, Gimeracil and Oteracil Potassium Capsules
Drug40mg/m2, D1-14 BID PO Q3W
Sintilimab Placebo
Drug200 mg, D1 IV Q3W
Sintilimab
Drug200mg D1 IV Q3W
Ipilimumab N01
Drug1mg/kg, D1 IV Q6W
Oxaliplatin for injection
Drug130 mg/m2 D1 IV Q3W
Ipilimumab N01 Placebo
Drug1mg/kg, D1 IV Q6W
Major Pathological Response (MPR) rate in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
The MPR rate is defined as the proportion of participants with a Tumor Regression Grade (TRG) score of 0 or 1 in the primary tumor after radical surgical resection following neoadjuvant therapy.
Event-Free Survival (EFS)
The EFS is defined as the time from randomization to the first occurrence of disease progression precluding curative resection, postoperative local recurrence, distant metastasis, or death from any cause.
pathological Complete Response (pCR) rate
The pCR rate is defined as the proportion of participants with no residual viable tumor in both the primary tumor and lymph nodes after radical surgical resection following neoadjuvant therapy.
Clinical Down-staging Rate
Clinical downstaging rate refers to the proportion of participants with a reduction in clinical TNM (cTNM) stage after neoadjuvant therapy.
R0 resection rate
The R0 resection rate is defined as the proportion of participants who underwent R0 resection.
Overall survival (OS)
OS is defined as the time from randomization to death due to any cause.
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