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NCT Number: NCT07547787

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

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.

Recruiting

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Key information

Conditions

Locally Advanced Unresectable or Metastatic Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Cancer Hospital

Beijing, China

Location status: Recruiting

Location contact

Jiafu Ji, MD, Principal Investigator

CONTACT

[email protected]

Lin Shen, MD, Principal Investigator

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jiafu Ji, MD

CONTACT

[email protected]

Zhifang Yao，MD

CONTACT

[email protected]

86-0760-89873999

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2030
Study completion
2040
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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