Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer

• Status: Recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

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 (CRC).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Changzheng Hospital
• Treatments: Immune Checkpoint Inhibitors; Nivolumab

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:

• Patient still has standard treatment therapy based on NCCN guidance;

• Patient can not comply with research program requirements or follow-up;