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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events (AE), rate of surgical delays, abnormal laboratory findings of clinical significance
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
- •Has adequate organ function.
排除标准
- •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
- •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.
研究组 & 干预措施
Part 2 cohort 2
Subjects receive cadonilimab combination chemotherapy(FLOT) and AK117 neoadjuvant therapy 4 cycles.
干预措施: Oxaliplatin (Drug)
Part 1 cohort 1
Subjects receive cadonilimab combination chemotherapy(SOX) neoadjuvant therapy 3 cycles.
干预措施: Cadonilimab (Drug)
Part 1 cohort 1
Subjects receive cadonilimab combination chemotherapy(SOX) neoadjuvant therapy 3 cycles.
干预措施: Oxaliplatin (Drug)
Part 1 cohort 1
Subjects receive cadonilimab combination chemotherapy(SOX) neoadjuvant therapy 3 cycles.
干预措施: Tegafur-gimeracil-oteracil potassium (Drug)
Part 1 cohort 2
Subjects receive cadonilimab combination chemotherapy(SOX) and AK117 neoadjuvant therapy 3 cycles.
干预措施: Cadonilimab (Drug)
Part 1 cohort 2
Subjects receive cadonilimab combination chemotherapy(SOX) and AK117 neoadjuvant therapy 3 cycles.
干预措施: AK117 (Drug)
Part 1 cohort 2
Subjects receive cadonilimab combination chemotherapy(SOX) and AK117 neoadjuvant therapy 3 cycles.
干预措施: Oxaliplatin (Drug)
Part 1 cohort 2
Subjects receive cadonilimab combination chemotherapy(SOX) and AK117 neoadjuvant therapy 3 cycles.
干预措施: Tegafur-gimeracil-oteracil potassium (Drug)
Part 2 cohort 1
Subjects receive cadonilimab combination chemotherapy(FLOT) neoadjuvant therapy 4 cycles.
干预措施: Cadonilimab (Drug)
Part 2 cohort 1
Subjects receive cadonilimab combination chemotherapy(FLOT) neoadjuvant therapy 4 cycles.
干预措施: Oxaliplatin (Drug)
Part 2 cohort 1
Subjects receive cadonilimab combination chemotherapy(FLOT) neoadjuvant therapy 4 cycles.
干预措施: Docetaxel (Drug)
Part 2 cohort 2
Subjects receive cadonilimab combination chemotherapy(FLOT) and AK117 neoadjuvant therapy 4 cycles.
干预措施: Docetaxel (Drug)
Part 2 cohort 1
Subjects receive cadonilimab combination chemotherapy(FLOT) neoadjuvant therapy 4 cycles.
干预措施: 5-Fluorouracil (Drug)
Part 2 cohort 2
Subjects receive cadonilimab combination chemotherapy(FLOT) and AK117 neoadjuvant therapy 4 cycles.
干预措施: Cadonilimab (Drug)
Part 2 cohort 2
Subjects receive cadonilimab combination chemotherapy(FLOT) and AK117 neoadjuvant therapy 4 cycles.
干预措施: AK117 (Drug)
Part 2 cohort 2
Subjects receive cadonilimab combination chemotherapy(FLOT) and AK117 neoadjuvant therapy 4 cycles.
干预措施: 5-Fluorouracil (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AE), rate of surgical delays, abnormal laboratory findings of clinical significance
时间窗: Up to approximately 2 years
Pathological complete response (pCR) rates
时间窗: Up to approximately 2 years
pCR is defined the 0% residual viable tumor cells in the primary tumor and sampled lymph nodes
次要结局
- ADA(Up to approximately 2 years)
- PK(Up to approximately 2 years)
- Tumor regression grade(TRG)(Up to approximately 2 years)
- Tumor descending stage rate(Up to approximately 2 years)
- EFS(Up to approximately 2 years)
- Major pathological response(MPR) rates(Up to approximately 2 years)
- ORR(Up to approximately 2 years)
- OS(Up to approximately 2 years)
- R0 resection rate(Up to approximately 2 years)