A Phase Ib/III, Open-Label, Randomized Study of Neoadjuvant QL1706 Versus Standard of Care in Participants With Untreated of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 363
- 试验地点
- 1
- 主要终点
- Pathological Complete Response(pCR), defined as the proportion of subjects with no residual tumor in the primary tumor removed and in all lymph nodes removed after neoadjuvant therapy.
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of neoadjuvant QL1706 in participants with untreated T4N0 or Stage III (resectable), microsatellite instability high/ defective mismatch repair (MSI-H/dMMR) colon cancer
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
- 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
- •Signed written informed consent;
- •Eastern Cooperative Oncology Group Performance Status of 0 or 1
- •Untreated pathologically confirmed colon adenocarcinoma
- •Radiographic assessment showed a resectable stage IIB-III based on AJCC Stage VIII (cT4 or cN+ only).
- •Has a tumor demonstrating the presence of MSI-H/ dMMR
- •Adequate organ function as described in the protocol
排除标准
- •Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc
- •Has distant metastatic disease.
- •Has an active autoimmune disease that has required systemic treatment in past 2 years
- •Has know history of, or any evidence of interstitial lung disease;
- •Has an active infection requiring systemic therapy
研究组 & 干预措施
Experimental group
Phase Ib/Ⅲ Participants will receive QL1706 pre surgery
干预措施: QL1706 (Drug)
Phase III Control group
Participants will receive SOC (CAPEOX/Capecitabine) or undergo expectant observation post surgery.
干预措施: CAPEOX/Capecitabine (Drug)
结局指标
主要结局
Pathological Complete Response(pCR), defined as the proportion of subjects with no residual tumor in the primary tumor removed and in all lymph nodes removed after neoadjuvant therapy.
时间窗: 1 month after surgery
Event Free Survival, EFS(EFS), defined as the time from randomization to either disease recurrence or death due to any cause or treatment related toxicity that results in the participant not being suitable for surgery.
时间窗: Up to approximately 5 years
次要结局
- Overall Survival (OS)(Up to approximately 5 years)
- R0 tumor resection rate(2 week after surgery)
- Number of Participants with treatment emergent adverse events (AEs), serious adverse events (SAEs), Immune-mediated Adverse Event (imAEs), AEs leading to death and AEs leading to discontinuation of study treatment(Up to approximately 5 years)