Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer

Study Overview
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Brief Summary
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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).

Official Title
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The Efficacy and Safety of Regorafenib Plus PD-1 Inhibitor as Third-line Therapy in Advanced Colorectal Cancer Patients

Conditions
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Colorectal Cancer, Immunotherapy

Intervention / Treatment
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* Drug: Regorafenib and PD-1 inhibitor


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immunotherapy Combination treatment<br>All colorectal cancer patients received regorafenib plus PD-1 inhibitor | Drug: Regorafenib and PD-1 inhibitor<br>* All Colorectal cancer patients received regorafenib (80mg qd d1-d21,q4w) and PD-1 inhibitor. The patients could receive one type of PD-1 inhibitors according to oneself circumstance consideration including nivolumab (3mg/kg, ivgtt, q2w), Carelizumab (200mg, ivgtt, q3w), Sintilimab (200mg, ivgtt, q3w), Toripalimab(240mg ivgtt, q3w).<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer, Immunotherapy, Regorafenib, Nivoluamb, microsatellite stable