NCT07547787

Brief Summary

This is an observational and non-interventional clinical study that only collects long-term follow-up data of the subjects. As the world's first approved PD-1/CTLA-4 bispecific antibody for marketing, Cadonilimab may confer long-term survival benefits.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
610

participants targeted

Target at P75+ for all trials

Timeline
178mo left

Started Dec 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Dec 2024Dec 2040

Study Start

First participant enrolled

December 26, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2040

Last Updated

April 23, 2026

Status Verified

December 1, 2025

Enrollment Period

6 years

First QC Date

April 17, 2026

Last Update Submit

April 17, 2026

Conditions

Locally Advanced Unresectable or Metastatic Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Up to approximately 5 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects are enrolled from participants who previously took part in the sponsor-initiated clinical trials of cadonilimab (AK104).

You may qualify if:

  • Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed.
  • Subjects have received prior systemic therapy in sponsor-initiated clinical trials of cadonilimab (AK104), and this extension study is conducted after the completion of the original trial.
  • Agree to proceed with the extended follow-up procedures.
  • This is an observational and non-interventional clinical study, in which subjects are allowed to participate in other clinical studies at the same time.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Cancer Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Jiafu Ji, MD

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

  • Lin Shen, MD

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhifang Yao，MD

CONTACT

86-0760-89873999clinicaltrials@akesobio.com

Jiafu Ji, MD

CONTACT

jijiafu@hsc.pku.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2026

First Posted

April 23, 2026

Study Start

December 26, 2024

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2040

Last Updated

April 23, 2026

Record last verified: 2025-12

Locations

CN(1)