Phase IIA Clinical Trial of Intra-arterial Administration of Tirapazamine Followed by Transarterial Embolization （TATE）and KN046 for the Treatment of Advanced Colorectal Cancer with Liver Metastasis (MSS/pMMR)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
A single-arm, multicenter, Phase IIA study of Intra-arterial Administration of Tirapazamine followed by Transarterial Embolization (TATE) and KN046 (recombinant humanized anti-PD-L1/CTLA-4 bispecific single-domain antibody Fc fusion protein injection) in patients with liver metastases from colorectal cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver metastatic MSS/pMMR-mCRC;
- •mCRC progressed on at least two lines of standard chemotherapy;
- •Measurable disease;
- •ECOG 0-1;
- •Adequate organ function
排除标准
- •Prior organ transplantation;
- •Oxygen saturation less than 92% in room air;
- •Prior autoimmune disorder;
- •Major GI bleeding in the last 2 months;
- •Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody therapy, or any other antibody or drug that specifically targets T-cell co-stimulation or immune checkpoint pathways.
研究组 & 干预措施
TATE and KN046
On Day 1, patients will receive KN046 at a dose of 5 mg/kg. On Day 8 (+/-1), patients will receive TATE (Tirapazamine 35 mg). Each treatment cycle is 21 days. Patients will receive two cycles of treatment. After necrosis of liver tumors, whether to continue TATE treatment in the third cycle and beyond will be decided by the study physician based on the extent of tumor necrosis.
干预措施: KN046 （PD-L1/CTLA4 BsAb） (Drug)
TATE and KN046
On Day 1, patients will receive KN046 at a dose of 5 mg/kg. On Day 8 (+/-1), patients will receive TATE (Tirapazamine 35 mg). Each treatment cycle is 21 days. Patients will receive two cycles of treatment. After necrosis of liver tumors, whether to continue TATE treatment in the third cycle and beyond will be decided by the study physician based on the extent of tumor necrosis.
干预措施: TATE：Intra-arterial Administration of Tirapazamine followed by Transarterial Embolization (Procedure)
结局指标
主要结局
ORR
时间窗: 24 months
Objective Response Rate (assessed by mRECIST/RECIST)
OS
时间窗: 24 months
Overall Survival
次要结局
- DCR(24 months)
- PFS(24 months)
- survival rates(24 months)