Combining cadonilimab with chemotherapy for gastric cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II trial evaluates the efficacy and safety of cadonilimab combined with chemotherapy, with or without AK117, in patients with resectable gastric or gastroesophageal junction adenocarcinoma. Participants must have a confirmed diagnosis and meet specific health criteria, including an ECOG performance status of 0 or 1. The study aims to determine the effectiveness of this combination treatment as a neoadjuvant therapy before surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Be able and willing to provide written informed consent.
* 18 to 75 years old.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Has a histologically confirmed diagnosis of Gastric or Gastroesophageal Junction Adenocarcinoma(G/GEJ).
* Has Stage T3-4N+M0 G/GEJ (American Joint Committee on Cancer \[AJCC\])
* Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
* Has adequate organ function.

Exclusion Criteria:

* Are there suspected metastases or locally advanced, unresectable disease, regardless of disease stage.
* Is currently participating in a study of an investigational agent or using an investigational device.
* Has undergone major surgery within 30 days of Study Day 1.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
* History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
* Has received a live virus vaccine within 30 days of the planned first dose of study therapy.

Where it's running

• Tianjin Provincial Tumor Hospital
  Tianjin, China Recruiting

Study contacts

• Study coordinator: Weifeng Song, MD
• Email: clinicaltrials@akesobio.com
• Phone: +86(0760)89873999

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.