Neoadjuvant Cadonilimab Combined With Perioperative Oxaliplatin Plus S1 for Diffuse or Mixed Type of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

PHASE3RecruitingINTERVENTIONAL
Enrollment

668

Participants

Timeline

Start Date

May 15, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2030

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

Neoadjuvant cadonilimab combined with perioperative SOX

Cadonilimab: 10 mg/kg, iv, day 1 of every 3 weeks Oxaliplatin: 130 mg/m², iv, day 1 of every 3 weeks S1: 40-60 mg/m², po, day 1-14 of every 3 weeks (BSA \< 1.25 m², 40 mg \* 2/day, 1.25 m² ≤ BSA \< 1.5 m², 50 mg \* 2/day, BSA ≥ 1.5 m², 60 mg \* 2/day)

DRUG

Neoadjuvant placebo plus perioperative SOX

Placebo: iv, day 1 of every 3 weeks Oxaliplatin: 130 mg/m², iv, day 1 of every 3 weeks S1: 40-60 mg/m², po, day 1-14 of every 3 weeks (BSA \< 1.25 m², 40 mg \* 2/day, 1.25 m² ≤ BSA \< 1.5 m², 50 mg \* 2/day, BSA ≥ 1.5 m², 60 mg \* 2/day)

Trial Locations (4)

730000

RECRUITING

Gansu Provincial Hospital, Lanzhou

RECRUITING

Lanzhou University Second Hospital, Lanzhou

RECRUITING

The First Hospital of Lanzhou University, Lanzhou

RECRUITING

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

All Listed Sponsors
lead

Zuoyi Jiao

OTHER