A Long-term Follow-up Study of Subjects Enrolled in Clini... | NCT07547787

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

NCT07547787

Sponsor

Akeso

Status

Recruiting

Last Update Posted

Apr 23, 2026Actual

Enrollment

610Estimated

Phase

Not provided

Conditions

Locally Advanced Unresectable or Metastatic Gastric Cancer

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 26, 2024Actual

Primary Completion Date

Dec 31, 2030Estimated

Completion Date

Dec 31, 2040Estimated

First Submitted Date

Apr 17, 2026

First Submission Date that Met QC Criteria

Apr 17, 2026

First Posted Date

Apr 23, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2026

Last Update Posted Date

Apr 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

610Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhifang Yao，MD	Contact	86-0760-89873999		clinicaltrials@akesobio.com
Jiafu Ji, MD	Contact			jijiafu@hsc.pku.edu.cn

Overall Officials

Name	Affiliation	Role
Jiafu Ji, MD	Peking University Cancer Hospital & Institute	Principal Investigator
Lin Shen, MD	Peking University Cancer Hospital & Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Cancer Hospital	Recruiting	Beijing			China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided