Neoadjuvant Apatinib Combined With Sintilimab and Perioperative SOX Versus Neoadjuvant Sintilimab Combined With Perioperative SOX for Intestinal Type of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

PHASE3RecruitingINTERVENTIONAL
Enrollment

682

Participants

Timeline

Start Date

April 15, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2030

Conditions
Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ])Neoadjuvant TherapyAdjuvant ChemotherapypCR RateMPRORR,OS,PFS
Interventions
DRUG

Neoadjuvant apatinib combined with sintilimab and perioperative SOX

Sintilimab: 200mg, iv, day 1 Oxaliplatin: 130 mg/m², iv, day 1 S-1: 40-60 mg/m², po, day 1-14 (BSA \< 1.25 m², 40 mg bid, 1.25 m² ≤ BSA \< 1.5 m², 50 mg bid, BSA ≥ 1.5 m², 60 mg bid) Apatinib: 250mg, po, day1-21, for 3 cycles preoperatively

DRUG

Neoadjuvant sintilimab combined with perioperative SOX

Sintilimab: 200mg, iv, day 1 Oxaliplatin: 130 mg/m², iv, day 1 S-1: 40-60 mg/m², po, day 1-14 (BSA \< 1.25 m², 40 mg bid, 1.25 m² ≤ BSA \< 1.5 m², 50 mg bid, BSA ≥ 1.5 m², 60 mg bid)

Trial Locations (4)

730000

RECRUITING

First Hospital of Lanzhou University, Lanzhou

RECRUITING

Gansu Provincial Hospital, Lanzhou

RECRUITING

Lanzhou University Second Hospital, Lanzhou

RECRUITING

The Gastrointestinal Surgery Department, Sun Yat-sen University Cancer Center Gansu Hospital, Lanzhou

All Listed Sponsors
lead

Zuoyi Jiao

OTHER