The Efficacy and Safety of Fluzoparib Plus Irinotecan as Second-line Treatment in Patients With Homologous Recombination Deficiency (HRD) Metastatic Colorectal Cancer.

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Irinotecan

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;