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

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Trial Identification

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

Official Title: 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 .

Study ID: NCT05732129

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Department of Colorectal Surgery Fudan University Shanghai Caner Center, Shanghai, Shanghai, China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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