NCT05008783

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

Completed Phase 3 Last updated 19 November 2025

What this trial tests

Phase 3 trial testing AK104 in Gastric Adenocarcinoma in 610 participants. Completed in 1 August 2025.

Timeline

17 September 2021

Primary endpoint
6 December 2024

1 August 2025

Quick facts

Lead sponsor	Akeso
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	610
Start date	17 September 2021
Primary completion	6 December 2024
Estimated completion	1 August 2025
Sites	7 locations across China

Drugs / interventions tested

• AK104 — full drug profile →
• Placebo

Conditions studied

• Gastric Adenocarcinoma — all drugs for Gastric Adenocarcinoma →
• Gastroesophageal Junction Adenocarcinoma — all drugs for Gastroesophageal Junction Adenocarcinoma →

Sponsor

Akeso — full company profile →

Who can join

Adults 18 to 75, any sex, with Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A randomized, Double-blind, Multicenter, phase III Clinical Study of Comparing the Efficacy and Safety of AK104 Plus Oxaliplatin and Capecitabine (XELOX) Versus Placebo Plus XELOX as First-line Treatment for locally advanced Unresectable or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Signaling pathways and therapeutic interventions in gastric cancer.
   Lei ZN, Teng QX, Tian Q, Chen W, et al · · 2022 · cited 220× · PMID 36209270 · DOI 10.1038/s41392-022-01190-w
2. Trial watch: chemotherapy-induced immunogenic cell death in oncology.
   Sprooten J, Laureano RS, Vanmeerbeek I, Govaerts J, et al · · 2023 · cited 59× · PMID 37284695 · DOI 10.1080/2162402x.2023.2219591
3. Recent developments in immunotherapy for gastrointestinal tract cancers.
   Chong X, Madeti Y, Cai J, Li W, et al · · 2024 · cited 52× · PMID 39123202 · DOI 10.1186/s13045-024-01578-x
4. First-line cadonilimab plus chemotherapy in HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma: a randomized, double-blind, phase 3 trial.
   Shen L, Zhang Y, Li Z, Zhang X, et al · · 2025 · cited 48× · PMID 39843940 · DOI 10.1038/s41591-024-03450-4
5. A phase 1a/1b first-in-human study (COMPASSION-01) evaluating cadonilimab in patients with advanced solid tumors.
   Frentzas S, Gan HK, Cosman R, Coward J, et al · · 2023 · cited 32× · PMID 37852261 · DOI 10.1016/j.xcrm.2023.101242
6. Current status and perspectives of esophageal cancer: a comprehensive review.
   Jiang W, Zhang B, Xu J, Xue L, et al · · 2025 · cited 28× · PMID 39723635 · DOI 10.1002/cac2.12645
7. Immune checkpoint inhibitors in cancer therapy: what lies beyond monoclonal antibodies?
   Zamani MR, Šácha P. · · 2025 · cited 19× · PMID 40536609 · DOI 10.1007/s12032-025-02822-1
8. Unveiling promising targets in gastric cancer therapy: A comprehensive review.
   Li W, Wei J, Cheng M, Liu M. · · 2024 · cited 10× · PMID 39280587 · DOI 10.1016/j.omton.2024.200857