Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
Phase 2
Recruiting
- Conditions
- Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
- Interventions
- Registration Number
- NCT05960955
- Lead Sponsor
- Akeso
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 cohort 2 Tegafur-gimeracil-oteracil potassium Subjects receive cadonilimab combination chemotherapy(SOX) and AK117 neoadjuvant therapy 3 cycles. Part 1 cohort 1 Tegafur-gimeracil-oteracil potassium Subjects receive cadonilimab combination chemotherapy(SOX) neoadjuvant therapy 3 cycles. Part 1 cohort 2 Cadonilimab Subjects receive cadonilimab combination chemotherapy(SOX) and AK117 neoadjuvant therapy 3 cycles. Part 2 cohort 2 AK117 Subjects receive cadonilimab combination chemotherapy(FLOT) and AK117 neoadjuvant therapy 4 cycles. Part 1 cohort 2 AK117 Subjects receive cadonilimab combination chemotherapy(SOX) and AK117 neoadjuvant therapy 3 cycles. Part 2 cohort 1 Cadonilimab Subjects receive cadonilimab combination chemotherapy(FLOT) neoadjuvant therapy 4 cycles. Part 2 cohort 1 Docetaxel Subjects receive cadonilimab combination chemotherapy(FLOT) neoadjuvant therapy 4 cycles. Part 2 cohort 1 5-Fluorouracil Subjects receive cadonilimab combination chemotherapy(FLOT) neoadjuvant therapy 4 cycles. Part 1 cohort 1 Cadonilimab Subjects receive cadonilimab combination chemotherapy(SOX) neoadjuvant therapy 3 cycles. Part 1 cohort 1 Oxaliplatin Subjects receive cadonilimab combination chemotherapy(SOX) neoadjuvant therapy 3 cycles. Part 1 cohort 2 Oxaliplatin Subjects receive cadonilimab combination chemotherapy(SOX) and AK117 neoadjuvant therapy 3 cycles. Part 2 cohort 1 Oxaliplatin Subjects receive cadonilimab combination chemotherapy(FLOT) neoadjuvant therapy 4 cycles. Part 2 cohort 2 Cadonilimab Subjects receive cadonilimab combination chemotherapy(FLOT) and AK117 neoadjuvant therapy 4 cycles. Part 2 cohort 2 Oxaliplatin Subjects receive cadonilimab combination chemotherapy(FLOT) and AK117 neoadjuvant therapy 4 cycles. Part 2 cohort 2 Docetaxel Subjects receive cadonilimab combination chemotherapy(FLOT) and AK117 neoadjuvant therapy 4 cycles. Part 2 cohort 2 5-Fluorouracil Subjects receive cadonilimab combination chemotherapy(FLOT) and AK117 neoadjuvant therapy 4 cycles.
- Primary Outcome Measures
Name Time Method Incidence and severity of adverse events (AE), rate of surgical delays, abnormal laboratory findings of clinical significance Up to approximately 2 years Pathological complete response (pCR) rates Up to approximately 2 years pCR is defined the 0% residual viable tumor cells in the primary tumor and sampled lymph nodes
- Secondary Outcome Measures
Name Time Method EFS Up to approximately 2 years Tumor regression grade(TRG) Up to approximately 2 years Tumor descending stage rate Up to approximately 2 years Proportion of subjects whose tumor TNM stage decreased from baseline before surgery
Major pathological response(MPR) rates Up to approximately 2 years MPR is defined the ≤10% residual viable tumor cells in the primary tumor and sampled lymph nodes
ORR Up to approximately 2 years OS Up to approximately 2 years PK Up to approximately 2 years Serum drug concentrations of cadonilimab and/or AK117 in individual subjects at different time points
ADA Up to approximately 2 years Number of subjects with detectable anti-drug antibodies (ADA).
R0 resection rate Up to approximately 2 years
Trial Locations
- Locations (1)
Tianjin Provincial Tumor Hospital
🇨🇳Tianjin, China