NCT07547787

Recruiting

A Long-term Follow-up Study of Subjects Enrolled in Clinical...

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Other study identifiers

Sponsor study identifier

AK104-EXT-01

Study Type

observational

Estimated enrollment

610

Locations

1 country

Sites

1

Timeline

Study Start

December 26, 2024

Actual (reported)

Primary Completion

December 31, 2030

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

December 31, 2040

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Estimated enrollment: 610 participants
Study completion date: December 31, 2040
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 26, 2024
Actual (reported)
First Submitted
April 17, 2026
Actual (reported)
First Posted
April 23, 2026
Actual (reported)
Primary Completion
December 31, 2030
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2040
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: April 23, 2026
Status Verified: December 2025
Last Update Submitted: 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.

Sponsors & Collaborators

Akeso
Industrylead

Study Sites (1)

Peking University Cancer Hospital

Beijing, China

RECRUITING

Jiafu Ji, MD, Principal InvestigatorCONTACTjijiafu@hsc.pku.edu.cn

Lin Shen, MD, Principal InvestigatorCONTACT

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

86-0760-89873999 clinicaltrials@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

Actual (reported)

Primary Completion

December 31, 2030

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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.

Study Completion

December 31, 2040

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

April 23, 2026

Record last verified: 2025-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT07547787
Data provider: ClinicalTrials.gov
Source updated: 2026-04-23
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:14 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations