The Efficacy and Safety of Fluzoparib Plus Irinotecan as Second-line Treatment in Patients With Homologous Recombination Deficiency (HRD) Metastatic Colorectal Cancer.
Homologous Recombination Deficiency Alterations Metastatic Colorectal Cancer
About this trial
This is an interventional treatment trial for Homologous Recombination Deficiency Alterations Metastatic Colorectal Cancer focused on measuring Fluzoparib Plus Irinotecan, Homologous Recombination Deficiency (HRD) Alterations
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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;
Sites / Locations
- Department of Colorectal Surgery Fudan University Shanghai Caner Center
Arms of the Study
Arm 1
Experimental
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 .