SHR-1701 in Combination With Radiotherapy and Chemotherapy as Perioperative Treatment for Resectable Locally Advanced Rectal Cancer, an Open Label, Single-arm, Multicenter Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
研究概览
简要总结
This study will evaluate the efficacy and safety of SHR-1701 combined with radiotherapy and chemotherapy as perioperative treatment for locally advanced rectal cancer. Eligible patients will receive standard chemoradiation with SHR-1701 followed by XELOX combined with SHR-1701. In all subjects, restaging pelvic MRI with chest and abdominal CT will be performed after completion of neoadjuvant treatment to determine resectability and to rule out any evidence of metastases. Subjects who have resectable disease will undergo surgery. Adjuvant XELOX combined with SHR-1701 will be given after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 willing and able to provide written informed consent for the trial.
- •Locally advanced rectal adenocarcinoma and was evaluated as resectable ;
- •The inferior margin of the tumor ≤ 10 cm from the anal verge ;
- •No prior anti-cancer treatment for rectal cancer;
- •Estern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1;
- •Adequate hematologic and end-organ function;
- •Contraception was initiated from the signing of the informed consent until at least 6 months after the last dosing of the study drug
排除标准
- •Unresectable disease determined by investigators
- •Recurrent rectal cancer
- •Evidence of metastatic disease or lateral lymph node metastases
- •Presence of synchronous colorectal cancer
- •Presence of obstruction or imminent obstruction
- •Not eligible for long-course radiotherapy
- •Severe cardiovascular and cerebrovascular diseases;Have clinical heart symptoms or diseases that are not well controlled
- •Prior malignancy within the prior 5 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical/breast cancer.
研究组 & 干预措施
Perioperative treatment
Eligible subjects will receive standard chemoradiotherapy with SHR-1701 followed by XELOX combined with SHR-1701 and surgery. Adjuvant XELOX combined with SHR-1701 will be given after surgery.
干预措施: SHR-1701；Capecitabine；Oxaliplatin (Drug)
结局指标
主要结局
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
时间窗: At week 16, DAY1
Percentage of participants with Pathological complete response ( pCR )
时间窗: At week 16, DAY1
次要结局
- Tumor regression grade ( TRG )(At week 16, DAY1)
- Percentage of participants with R0 Resection ( R0 )(At week 16, DAY1)
- Event-free survival ( EFS )(Year 1, Year 2, Year 3)
- Disease-free survival ( DFS )(Year 1, Year 2, Year 3)
- Percentage of participants with Clinical complete response ( cCR ) rate.(At week 16, DAY1)
- Overall survival ( OS )(Year 1, Year 2, Year 3)