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Trial Title:
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
Condition:
Homologous Recombination Deficiency Alterations Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Irinotecan
Fluzoparib
Conditions: Keywords:
Fluzoparib Plus Irinotecan
Homologous Recombination Deficiency (HRD) Alterations
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fluzoparib
Description:
150mg,orally, bid (days 1-7) every 2 weeks
Arm group label:
Fluzoparib plus Irinotecan
Intervention type:
Drug
Intervention name:
Irinotecan
Description:
30-90min continuous infusion 180mg/m2 Irinotecan on day 1, q2w
Arm group label:
Fluzoparib plus Irinotecan
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.
Criteria for 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Colorectal Surgery Fudan University Shanghai Caner Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Start date:
March 1, 2023
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05732129
