A Randomized, Double-blind, Phase III Clinical Study Comparing the Efficacy and Safety of Cadonilimab Plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX) Versus Placebo Plus SOX as Perioperative Treatment for Patients With Resectable Gastric and Gastroesophageal Junction (G/GEJ) Adenocarcinoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 760
- 试验地点
- 6
- 主要终点
- Event-free survival (EFS)
研究概览
简要总结
This study investigates treatment of cadonilimab or placebo combined with SOX chemotherapy (oxaliplatin + tegafur-gimeracil-oteracil potassium) given before surgery (neoadjuvant) and cadonilimab or placebo combined with SOX chemotherapy after surgery (adjuvant), will work and be safe for the treatment of resectable (removable by surgery) gastric or gastroesophageal cancer.
详细描述
This trial is a Phase 3 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 for perioperative treatment of resectable gastric or gastroesophageal junction adenocarcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with histologically confirmed gastric or gastroesophageal junction adenocarcinoma with resectable disease (clinical stage T3-4aN+M0 or T4bNanyM0 per AJCC 8th edition).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
- •Has life expectancy of at least 6 months.
- •Availability of tumor sample prior to study entry.
- •Patients must undergo radical surgery.
- •Has adequate organ function.
排除标准
- •Patients with unresectable locally advanced disease or distant metastasis.
- •Histopathology or cytology confirmed other pathological types, such as adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor.
- •Current or prior use of immunosuppressive medication within 14 days before randomization.
- •Has received prior anti-cancer therapy for the current malignancy.
- •Has an active infection requiring systemic therapy.
- •Contra-indication to any of the study drugs.
- •Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.
- •Has an active autoimmune disease that has required systemic treatment in past 2 years.
- •Known active Hepatitis B or Hepatitis C virus infection.
- •Has had an allogenic tissue/solid organ transplant.
研究组 & 干预措施
cadonilimab+SOX
Cadonilimab plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX)
干预措施: Cadonilimab (Drug)
cadonilimab+SOX
Cadonilimab plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX)
干预措施: SOX chemotherapy (Drug)
Placebo+SOX
Placebo plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX)
干预措施: SOX chemotherapy (Drug)
Placebo+SOX
Placebo plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX)
干预措施: Placebo (Drug)
结局指标
主要结局
Event-free survival (EFS)
时间窗: Up to 5 years
EFS is the time from date of randomization until the date of disease progression or death.
Pathological Complete Response (pathCR) Rate
时间窗: Up to approximately 2 years
PathCR rate is defined as the percentage of participants having a pathCR assessed by the investigators. PathCR is defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes.
次要结局
- Overall survival (OS)(Up to 10 years)
- Disease-free Survival (DFS)(Up to 5 years)
- Number of Participants Who Experience One or More Adverse Events (AEs)(Up to 5 years)