NCT04110093UnknownPhase 1

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

Shanghai Changzheng Hospital1 site in 1 country120 target enrollmentStarted: March 1, 2019Last updated: December 30, 2020

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Sponsor: Shanghai Changzheng Hospital
Enrollment: 120
Locations: 1
Primary Endpoint: Objective Response Rate

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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).

Study Design

Study Type: Interventional
Allocation: Na
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to 75 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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;

Arms & Interventions

Immunotherapy Combination treatment

Experimental

All colorectal cancer patients received regorafenib plus PD-1 inhibitor

Intervention: Regorafenib and PD-1 inhibitor (Drug)

Outcomes

Primary Outcomes

Objective Response Rate

Time Frame: 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

Time Frame: 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 Outcomes

Overall Survival(From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months)
Adverse Effect(Through study completion, an average of 1 months)

Investigators

Sponsor

Shanghai Changzheng Hospital

Sponsor Class

Other

Responsible Party

Principal Investigator

Yuan-Sheng Zang

Head of Medical Oncology Department

Shanghai Changzheng Hospital

Study Sites (1)

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