The Efficacy and Safety of Fluzoparib Combined With Fluzoparib as Second-line Treatment in Patients With Homologous Recombination Deficiency (HRD) Metastatic Colorectal Cancer: A Single-center, Open-label, Single-arm Study .
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Objective response rate of Metastatic Colorectal Cancer,inculdthe proportion of patients with complete response or partial response
研究概览
简要总结
Preclinical data support the investigation of PARP inhibitors in other neoplasms exhibiting homologous recombination deficiency (HRD) as monotherapy as well as in combination with chemotherapy. However，in colorectal cancer (CRC), the role of HRD alterations is mostly unknown. This study aims to explore the the Efficacy and Safety of Fluzoparib combined with Irinotecan in the Second-line treatment of HRD alterations metastatic colorectal cancer.
详细描述
Study protocol for an open-label, single-arm, phase II study of combination of Fluzoparib and rinotecan as the second-line treatment for patients with HRD alterations metastatic colorectal cancer (mCRC). Patients will receive Fluzoparib combined with Irinotecan treatment protocol, which included irinotecan asintravenous infusion at 180mg/m2 (on day 1) and Fluzoparib 150mg capsules given bid (days 1-7) every 2 weeks.
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
- •18-75 years；
- •Histological or cytological confirmed metastatic colorectal cancer;
- •HRD alterations（inclued BRCA1/2、ATM、CDK12、PALB2、Check2、RAD51C、RAD51D etc.）；
- •Intolerability toxicity occurs 8 weeks within first-line therapy;
- •ECOG PS 0-1;
- •Adequate hepatic, renal, heart, and hematologic functions;
- •Negative serum pregnancy test at screening for women of childbearing potential;
- •Informed consent was signed before the study began.
排除标准
- •Prior treatment with PARPi drugs；
- •Symptomatic brain or meningeal metastases；
- •Patients have received local radiotherapy within 1 month prior to treatment;
- •Patients who had active bleeding or coagulopathy before enrollment, had a tendency to bleed, or were receiving thrombolytic therapy and were considered by the investigator to be ineligible for enrollment;
- •Women who are pregnant (with a positive pregnancy test before medication) or breastfeeding;
- •Expected survival <3 months;
- •Received other investigational drugs within 4 weeks prior to treatment;
- •Patients who had active uncontrollable neurological, mental disease or mental disorder, poor compliance, unable to cooperate and describe the treatment response;
- •Allergy to the study drug or any of its excipients;
研究组 & 干预措施
Fluzoparib plus Irinotecan
Patients will receive Fluzoparib combined with Irinotecan treatment protocol, which included irinotecan asintravenous infusion at 180mg/m2 (on day 1) and Fluzoparib 150mg capsules given bid (days 1-7) every 2 weeks .
干预措施: Fluzoparib (Drug)
Fluzoparib plus Irinotecan
Patients will receive Fluzoparib combined with Irinotecan treatment protocol, which included irinotecan asintravenous infusion at 180mg/m2 (on day 1) and Fluzoparib 150mg capsules given bid (days 1-7) every 2 weeks .
干预措施: Irinotecan (Drug)
结局指标
主要结局
Objective response rate of Metastatic Colorectal Cancer,inculdthe proportion of patients with complete response or partial response
时间窗: assessed up to 1 year
using RECIST v 1.1.
次要结局
- Overall survival of Metastatic Colorectal Cancer, include time from randomization to death from any cause(assessed up to 2 year)
- The Safety of Fluzoparib Plus Irinotecan as Second-line Treatment in Patients With Homologous Recombination Deficiency (HRD) Metastatic Colorectal Cancer.(assessed up to 2 year)
- Progression-Free Survival of Metastatic Colorectal Cancer，includ time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first(assessed up to 1 year)
研究者
Ye Xu
Professor, Chief of Department of Colorectal Surgery
Fudan University