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Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer

Primary Purpose

Colorectal Cancer, Immunotherapy

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Regorafenib and PD-1 inhibitor

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Cancer, Immunotherapy, Regorafenib, Nivoluamb, microsatellite stable

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

Department of Medical Oncology, Shanghai Changzheng HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Immunotherapy Combination treatment

Arm Description

All colorectal cancer patients received regorafenib plus PD-1 inhibitor

Outcomes

Primary Outcome Measures

Objective Response Rate

Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission.

Progress Free Survival

Time from treatment beginning until disease progression

Secondary Outcome Measures

Overall Survival

Time from treatment beginning until death from any cause

Adverse Effect

Incidence of Treatment-related adverse Events

Full Information

NCT ID

NCT04110093

First Posted

September 28, 2019

Last Updated

December 28, 2020

Sponsor

Shanghai Changzheng Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04110093

Brief Title

Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2019 (Actual)

Primary Completion Date

August 31, 2021 (Anticipated)

Study Completion Date

August 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Changzheng Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Immunotherapy

Keywords

Colorectal Cancer, Immunotherapy, Regorafenib, Nivoluamb, microsatellite stable

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Immunotherapy Combination treatment

Arm Type

Experimental

Arm Description

All colorectal cancer patients received regorafenib plus PD-1 inhibitor

Intervention Type

Drug

Intervention Name(s)

Regorafenib and PD-1 inhibitor

Intervention Description

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).

Primary Outcome Measure Information:

Title

Objective Response Rate

Description

Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission.

Time Frame

Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months

Title

Progress Free Survival

Description

Time from treatment beginning until disease progression

Time Frame

Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months

Secondary Outcome Measure Information:

Title

Overall Survival

Description

Time from treatment beginning until death from any cause

Time Frame

From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months

Title

Adverse Effect

Description

Incidence of Treatment-related adverse Events

Time Frame

Through study completion, an average of 1 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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;

Facility Information:

Facility Name

Department of Medical Oncology, Shanghai Changzheng Hospital

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhan Wang

Phone

+86-13916229609

13916229609@139.com

First Name & Middle Initial & Last Name & Degree

Yuan-Sheng Zang

12. IPD Sharing Statement

Learn more about this trial

Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer

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