Resectable Gastric or Gastroesophageal Junction Adenocarcinoma Clinical Trial
Official title:
Phase II Clinical Study of Cadonilimab Combination With Chemotherapy With or Without the Anti-CD47 Antibody AK117 Neoadjuvant/Adjuvant Therapy for Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
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.
| Status | Recruiting |
| Enrollment | 90 |
| Est. completion date | November 30, 2027 |
| Est. primary completion date | November 30, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Tianjin Provincial Tumor Hospital | Tianjin |
| Lead Sponsor | Collaborator |
|---|---|
| Akeso |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence and severity of adverse events (AE), rate of surgical delays, abnormal laboratory findings of clinical significance | Up to approximately 2 years | ||
| Primary | Pathological complete response (pCR) rates | pCR is defined the 0% residual viable tumor cells in the primary tumor and sampled lymph nodes | Up to approximately 2 years | |
| Secondary | Major pathological response(MPR) rates | MPR is defined the =10% residual viable tumor cells in the primary tumor and sampled lymph nodes | Up to approximately 2 years | |
| Secondary | Tumor regression grade(TRG) | Up to approximately 2 years | ||
| Secondary | R0 resection rate | Up to approximately 2 years | ||
| Secondary | Tumor descending stage rate | Proportion of subjects whose tumor TNM stage decreased from baseline before surgery | Up to approximately 2 years | |
| Secondary | ORR | Up to approximately 2 years | ||
| Secondary | EFS | Up to approximately 2 years | ||
| Secondary | OS | Up to approximately 2 years | ||
| Secondary | PK | Serum drug concentrations of cadonilimab and/or AK117 in individual subjects at different time points | Up to approximately 2 years | |
| Secondary | ADA | Number of subjects with detectable anti-drug antibodies (ADA). | Up to approximately 2 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04221555 -
Trial of Neoadjuvant Durvalumab Plus Docetaxel, Oxaliplatin, S-1 Followed by Surgery and Adjuvant Durvalumab Plus S-1 Chemotherapy in Potentially Resectable MMR Proficient Gastric or Gastroesophageal Junction Adenocarcinoma
|
Phase 2 |