Program Status
RecruitingPhase
Phase 1/Phase 2Prior Immunotherapy Allowed
YesCRC-directed Trial
YesDrugs
Regorafenib and PD-1 inhibitorTags
MSI-H/ MMRd, MSS/ MMRpComments
Regorafenib is an oncogenic receptor tyrosine kinase. Regorafenib shows anti-angiogenic activity due to its dual targeted VEGFR2-TIE2 tyrosine kinase inhibition.
Nivolumab is a monoclonal antibody and it is a human programmed death receptor-1 (PD-1) blocking antibody.
Similar to Japanese trial REGONIVO (NCT03406871): response rates of 29% in MSS CRC (7 patients), reported at ASCO19. See Helpful Links.
Location | Location Status |
---|---|
China | |
Department of Medical Oncology, Shanghai Changzheng Hospital Shanghai |
Recruiting |
Inclusion Criteria
Inclusion Criteria:
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 Criteria
Exclusion Criteria:
Patient still has standard treatment therapy based on NCCN guidance;
Patient can not comply with research program requirements or follow-up;