A Long-term Follow-up Study of Subjects Enrolled in Clinical Trials of Cadonilimab (AK104)

An Extension Study for Collecting Long-term Follow-up Data of Subjects Enrolled in Clinical Trials of Cadonilimab (AK104)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07547787

Enrollment

610

Registered

2026-04-23

Start date

2024-12-26

Completion date

2040-12-31

Last updated

2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Unresectable or Metastatic Gastric Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

1. 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. 2. 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. 3. Agree to proceed with the extended follow-up procedures. 4. This is an observational and non-interventional clinical study, in which subjects are allowed to participate in other clinical studies at the same time.

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
Overall Survival (OS)	Up to approximately 5 years	OS is defined as the time from randomization to death due to any cause.

Countries

China

Contacts

CONTACTZhifang Yao，MD

clinicaltrials@akesobio.com86-0760-89873999

CONTACTJiafu Ji, MD

jijiafu@hsc.pku.edu.cn

PRINCIPAL_INVESTIGATORJiafu Ji, MD

Peking University Cancer Hospital & Institute

PRINCIPAL_INVESTIGATORLin Shen, MD