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Trial Title:
Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
NCT ID:
NCT05960955
Condition:
Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Esophageal Neoplasms
Docetaxel
Oxaliplatin
Fluorouracil
Tegafur
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cadonilimab
Description:
IV infusion,Specified dose on specified days
Arm group label:
Part 1 cohort 1
Arm group label:
Part 1 cohort 2
Arm group label:
Part 2 cohort 1
Arm group label:
Part 2 cohort 2
Intervention type:
Drug
Intervention name:
AK117
Description:
IV infusion,Specified dose on specified days
Arm group label:
Part 1 cohort 2
Arm group label:
Part 2 cohort 2
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
IV infusion,Specified dose on specified days
Arm group label:
Part 1 cohort 1
Arm group label:
Part 1 cohort 2
Arm group label:
Part 2 cohort 1
Arm group label:
Part 2 cohort 2
Intervention type:
Drug
Intervention name:
Tegafur-gimeracil-oteracil potassium
Description:
Oral,Specified dose on specified days
Arm group label:
Part 1 cohort 1
Arm group label:
Part 1 cohort 2
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
IV infusion,Specified dose on specified days
Arm group label:
Part 2 cohort 1
Arm group label:
Part 2 cohort 2
Intervention type:
Drug
Intervention name:
5-Fluorouracil
Description:
IV infusion,Specified dose on specified days
Arm group label:
Part 2 cohort 1
Arm group label:
Part 2 cohort 2
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Provincial Tumor Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Han Liang, MD
Start date:
November 13, 2023
Completion date:
November 30, 2027
Lead sponsor:
Agency:
Akeso
Agency class:
Industry
Source:
Akeso
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05960955
