A Study of AK104 in the First-line Treatment of Locally Advanced Unresectable or Metastatic G/GEJ Adenocarcinoma

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

610

Participants

Timeline

Start Date

September 17, 2021

Primary Completion Date

April 18, 2025

Study Completion Date

October 18, 2025

Conditions
Gastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma
Interventions
DRUG

AK104

AK104 (administered on Day 1 of each cycle, Q3W)+Oxaliplatin (130 mg/m2 intravenous infusion for 2-6 hours on Day 1, Q3W,up to 6 cycles)+ Capecitabine(1000 mg/m2, p.o., Bid, Q3W,up to 6 cycles) . Afterward, AK104 will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W)

DRUG

Placebo

Placebo (administered on Day 1 of each cycle, Q3W)+Oxaliplatin (130 mg/m2 intravenous infusion for 2-6 hours on Day 1, Q3W,up to 6 cycles)+ Capecitabine(1000 mg/m2, p.o., Bid, Q3W,up to 6 cycles) . Afterward,Placebo will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W)

Trial Locations (7)

20032

Zhongshan Hospital, Fudan University, Shanghai

100143

Peking University Cancer Hospital, Beijing

200032

Fudan University Cancer Hospital, Shanghai

310003

The First Affiliated Hospital of Zhejiang University Medical College, Hangzhou

350014

Fujian Provincial Cancer Hospital, Fuzhou

610044

West China Hospital of Sichuan University, Chengdu

650118

Yunnan Cancer Hospital, Kunming

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Akeso

INDUSTRY

NCT05008783 - A Study of AK104 in the First-line Treatment of Locally Advanced Unresectable or Metastatic G/GEJ Adenocarcinoma | Biotech Hunter | Biotech Hunter