Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
Conditions
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.
Interventions
DRUGCadonilimab
IV infusion,Specified dose on specified days
DRUGAK117
IV infusion,Specified dose on specified days
DRUGOxaliplatin
IV infusion,Specified dose on specified days
Oral,Specified dose on specified days
DRUGDocetaxel
IV infusion,Specified dose on specified days
DRUG5-Fluorouracil
IV infusion,Specified dose on specified days
Sponsors
Akeso
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| R0 resection rate | 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 |
| ORR | Up to approximately 2 years | — |
| 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 |
| 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). |
| EFS | Up to approximately 2 years | — |
| Tumor regression grade(TRG) | Up to approximately 2 years | — |
Countries
China
Contacts
Primary ContactWeifeng Song, MD
Backup ContactHan Liang, MD
Outcome results
None listed