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

Sponsor
Fudan University
Study ID
NCT05732129
Phase
PHASE2
Status
Unknown

Conditions

  • Homologous Recombination Deficiency Alterations Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Fluzoparib — DRUG
    150mg,orally, bid (days 1-7) every 2 weeks
  • Irinotecan — DRUG
    30-90min continuous infusion 180mg/m2 Irinotecan on day 1, q2w

Study Details

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.

Key Dates

Start date
Mar 1, 2023
Status verified
Feb 2023
Primary completion
Nov 30, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
29 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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 .

Primary Outcome Measure

Objective response rate of Metastatic Colorectal Cancer,inculdthe proportion of patients with complete response or partial response [ Time Frame: assessed up to 1 year ]

Central Contacts