Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer

Phase 1

• Conditions: Colorectal Cancer; Immunotherapy
• Interventions: Drug: Regorafenib and PD-1 inhibitor

• Registration Number: NCT04110093
• Lead Sponsor: Shanghai Changzheng Hospital

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 (CRC).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-09-28
• Study First Submitted QC: 2019-09-28
• Study First Posted: 2019-10-01
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-28
• Last Update Posted: 2020-12-30
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Immunotherapy Combination treatment	Regorafenib and PD-1 inhibitor	All colorectal cancer patients received regorafenib plus PD-1 inhibitor

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months	Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission.
Progress Free Survival	Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months	Time from treatment beginning until disease progression

Secondary Outcome Measures

Name	Time	Method
Overall Survival	From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months	Time from treatment beginning until death from any cause
Adverse Effect	Through study completion, an average of 1 months	Incidence of Treatment-related adverse Events

Trial Locations

Locations (1)

Department of Medical Oncology, Shanghai Changzheng Hospital; 🇨🇳 Shanghai, China