Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT04110093

Recruitment Status : Recruiting

First Posted : October 1, 2019

Last Update Posted : December 30, 2020

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Yuan-Sheng Zang, Shanghai Changzheng Hospital

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).

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer Immunotherapy	Drug: Regorafenib and PD-1 inhibitor	Phase 1 Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	120 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	The Efficacy and Safety of Regorafenib Plus PD-1 Inhibitor as Third-line Therapy in Advanced Colorectal Cancer Patients
Actual Study Start Date :	March 1, 2019
Estimated Primary Completion Date :	August 31, 2021
Estimated Study Completion Date :	August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colorectal Cancer

Drug Information available for: Regorafenib

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Immunotherapy Combination treatment All colorectal cancer patients received regorafenib plus PD-1 inhibitor	Drug: 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).

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

Overall Survival [ Time Frame: 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 [ Time Frame: Through study completion, an average of 1 months ]
Incidence of Treatment-related adverse Events

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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;

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110093

Locations

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China
Department of Medical Oncology, Shanghai Changzheng Hospital	Recruiting
Shanghai, China
Contact: Zhan Wang +86-13916229609 13916229609@139.com
Principal Investigator: Yuan-Sheng Zang

Sponsors and Collaborators

Shanghai Changzheng Hospital

More Information

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Responsible Party:	Yuan-Sheng Zang, Head of Medical Oncology Department, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier:	NCT04110093
Other Study ID Numbers:	CZ-REGONIVO
First Posted:	October 1, 2019 Key Record Dates
Last Update Posted:	December 30, 2020
Last Verified:	December 2020

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Yuan-Sheng Zang, Shanghai Changzheng Hospital:


Colorectal Cancer Immunotherapy Regorafenib Nivoluamb microsatellite stable

Additional relevant MeSH terms:

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Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms	Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases

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