A Biomarker Study for Predicting the Efficacy of Neoadjuvant Sintilimab Plus SOX for Gastric Adenocarcinoma.

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

October 31, 2022

Primary Completion Date

September 30, 2023

Study Completion Date

October 31, 2025

Conditions
Gastric Cancer
Interventions
DRUG

Sintilimab

"Neoadjuvant treatment method: Sintilimab 200 mg, i.v., d1 + oxaliplatin 130 mg/m2, d1, i.v., + Tegafur 40 mg po, bid, d1-14; 3-week course; Neoadjuvant therapy: 3 courses of preoperative SOX chemotherapy (oxaliplatin+Tegafur) + PD-1 monoclonal antibody (Sintilimab).~After the 2nd and 3rd cycles of neoadjuvant therapy (6-9 weeks from the start of treatment), imaging effects and feasibility of radical surgery were performed respectively; The operation time is arranged within 2-6 weeks after the last administration of neoadjuvant therapy, and the operation method is selected by the surgeon according to the actual needs; The postoperative treatment plan is the same as the preoperative neoadjuvant treatment plan, and the SOX+Sintilimab will continue to be given until the full 8 cycles (including the preoperative 3 cycles)."

Sponsors
All Listed Sponsors
collaborator

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

collaborator

Nanjing Geneseeq Technology Inc.

INDUSTRY

lead

The First Affiliated Hospital with Nanjing Medical University

OTHER