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
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,
ChinaActive - Recruiting

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