Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

Recruiting now · Phase 2

Conditions studied: Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

In brief

This trial is a Phase II study. All patients are resectable Gastric or Gastroesophageal Junction Adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.The purpose of this study is to evaluate the efficacy and safety of cadonilimab combined with chemotherapy with or without AK117 neoadjuvantin treatment of resectable Gastric or Gastroesophageal Junction Adenocarcinoma.

Key facts

Study ID

NCT05960955

Run by

Akeso

People needed

90

Starts

2023-11-13

Expected to finish

2027-11-30

Last updated by the study team

2023-11-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Tianjin Provincial Tumor Hospital — Tianjin, China (enrolling)

Full record on ClinicalTrials.gov

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