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Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer

NCT ID: NCT04110093

Last Updated: 2020-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2021-08-31

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).

Detailed Description

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Conditions

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Colorectal Cancer Immunotherapy

Keywords

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Colorectal Cancer Immunotherapy Regorafenib Nivoluamb microsatellite stable

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immunotherapy Combination treatment

All colorectal cancer patients received regorafenib plus PD-1 inhibitor

Group Type EXPERIMENTAL

Regorafenib and PD-1 inhibitor

Intervention Type DRUG

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).

Interventions

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Regorafenib and PD-1 inhibitor

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).

Intervention Type DRUG

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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Changzheng Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yuan-Sheng Zang

Head of Medical Oncology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Medical Oncology, Shanghai Changzheng Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Zhan Wang

Role: primary

Other Identifiers

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CZ-REGONIVO

Identifier Type: -

Identifier Source: org_study_id