Long-term follow-up after cadonilimab (AK104) treatment
An Extension Study for Collecting Long-term Follow-up Data of Subjects Enrolled in Clinical Trials of Cadonilimab (AK104)
Akeso · NCT07547787
This follow-up collects long-term health and survival information from people with advanced gastric cancer who previously received cadonilimab (AK104) in earlier clinical trials.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 610 (estimated) |
| Sex | All |
| Sponsor | Akeso (industry) |
| Drugs / interventions | cadonilimab |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07547787 on ClinicalTrials.gov |
What this trial studies
This observational, non-interventional extension collects long-term follow-up data from participants who completed sponsor-initiated cadonilimab (AK104) trials for locally advanced unresectable or metastatic gastric cancer. After giving informed consent, participants' survival status, serious adverse events, subsequent anti-cancer treatments, and other long-term outcomes will be recorded without providing any study treatment. Enrollment is restricted to people who previously received cadonilimab in the original trials and agree to extended follow-up, and concurrent participation in other studies is permitted. Data will be collected at participating sites such as Peking University Cancer Hospital and via routine clinical visits or medical record review.
Who should consider this trial
Good fit: Ideal candidates are people with locally advanced unresectable or metastatic gastric cancer who previously received cadonilimab (AK104) in a sponsor trial, completed that trial, and can provide informed consent for extended follow-up.
Not a fit: Patients who did not receive cadonilimab previously, cannot provide informed consent, or who cannot be followed at the study site are unlikely to receive benefit from participation and should not expect direct therapeutic benefit because this is observational.
Why it matters
Potential benefit: If successful, this could clarify the long-term survival and safety profile after cadonilimab and help doctors and patients make more informed treatment decisions.
How similar studies have performed: Long-term observational follow-ups are commonly used for immunotherapies and have yielded useful survival and safety information for similar agents, but cadonilimab-specific long-term data remain limited given its recent approval.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing
- Peking University Cancer Hospital — Beijing, China (RECRUITING)
Study contacts
- Principal investigator: Jiafu Ji, MD — Peking University Cancer Hospital & Institute
- Study coordinator: Zhifang Yao，MD
- Email: clinicaltrials@akesobio.com
- Phone: 86-0760-89873999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Locally Advanced Unresectable or Metastatic Gastric Cancer