Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer

Naval Military Medical University (Second Military Medical University)

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Immunotherapy; Colorectal Cancer

Treatments: Drug: Regorafenib and PD-1 inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT04110093

CZ-REGONIVO

Details and patient eligibility

About

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 (CRC).

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

• Patient still has standard treatment therapy based on NCCN guidance;
• Patient can not comply with research program requirements or follow-up;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Immunotherapy Combination treatment

Experimental group

Description:

All colorectal cancer patients received regorafenib plus PD-1 inhibitor

Treatment:

Drug: Regorafenib and PD-1 inhibitor