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

NCT ID: NCT05732129

Last Updated: 2023-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2023-12-31

Brief 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.

Detailed Description

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.

Conditions

Homologous Recombination Deficiency Alterations Metastatic Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 .

Group Type: EXPERIMENTAL

Fluzoparib

Intervention Type: DRUG

150mg,orally, bid (days 1-7) every 2 weeks

Irinotecan

Intervention Type: DRUG

30-90min continuous infusion 180mg/m2 Irinotecan on day 1, q2w

Interventions

Fluzoparib

150mg,orally, bid (days 1-7) every 2 weeks

Intervention Type: DRUG

Irinotecan

30-90min continuous infusion 180mg/m2 Irinotecan on day 1, q2w

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Ye Xu

Professor, Chief of Department of Colorectal Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Colorectal Surgery Fudan University Shanghai Caner Center

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Ye Xu, PhD

Role: CONTACT

xu_shirley021@163.com

+86-21-6417-5590

Other Identifiers

2207257-12

Identifier Type: -

Identifier Source: org_study_id