Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer

Program Status

Recruiting

Phase

Phase 1/Phase 2

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

Yes

Drugs

Regorafenib and PD-1 inhibitor

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

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;

NCT ID

NCT04110093

Date Trial Added

2019-10-01

Updated Date

2020-12-30