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

• Status: Recruiting
• Trial end date: 2027-11-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akeso
• Treatments: Docetaxel; Fluorouracil; Oxaliplatin; Tegafur

Criteria

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.