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

Last updated: November 15, 2023
Sponsor: Akeso
Overall Status: Active - Recruiting

Phase

2

Condition

Esophageal Disorders

Digestive System Neoplasms

Adenocarcinoma

Treatment

Docetaxel

AK117

5-Fluorouracil

Clinical Study ID

NCT05960955
AK104-219
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 JunctionAdenocarcinoma(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

Exclusion Criteria:

  • Are there suspected metastases or locally advanced, unresectable disease, regardlessof disease stage.
  • Is currently participating in a study of an investigational agent or using aninvestigational 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 2years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressivedrugs).
  • 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 12months prior to day 1 of study treatment.
  • Has known psychiatric or substance abuse disorders that would interfere withcooperation with the requirements of the study.
  • Has received a live virus vaccine within 30 days of the planned first dose of studytherapy.

Study Design

Total Participants: 90
Treatment Group(s): 6
Primary Treatment: Docetaxel
Phase: 2
Study Start date:
November 13, 2023
Estimated Completion Date:
November 30, 2027

Connect with a study center

  • Tianjin Provincial Tumor Hospital

    Tianjin,
    China

    Active - Recruiting

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