Status:
UNKNOWN
Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer
Lead Sponsor:
Shanghai Changzheng Hospital
Conditions:
Colorectal Cancer
Immunotherapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is intended to evaluate efficacy and safety of the combination of regorafenib and nivolumab as third-line or later therapy in patients with microsatellite stable (MSS) colorectal cancer (CR...
Eligibility Criteria
Inclusion
- Advanced Colorectal Cancer diagnosed histologically;
- Patients with microsatellite stable (MSS)
- Patients have no any standard choice after multiple line of therapy( ≥ 2 lines);
- Expected survival ≥ 3 month;
- ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \<1.5 times the upper limit of normal (ULN); Liver ALT and AST \<2.5 × ULN and if liver metastases, ALT and AST \<5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min
Exclusion
- Patient still has standard treatment therapy based on NCCN guidance;
- Patient can not comply with research program requirements or follow-up;
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04110093
Start Date
March 1 2019
End Date
August 31 2021
Last Update
December 30 2020
Active Locations (1)
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1
Department of Medical Oncology, Shanghai Changzheng Hospital
Shanghai, China