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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05732129
Study type Interventional
Source Fudan University
Contact Ye Xu, PhD
Phone +86-21-6417-5590
Email xu_shirley021@163.com
Status Not yet recruiting
Phase Phase 2
Start date March 1, 2023
Completion date December 31, 2023