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Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04110093
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : December 30, 2020
Information provided by (Responsible Party):
Yuan-Sheng Zang, Shanghai Changzheng Hospital

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

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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

Drug Information available for: Regorafenib

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).

Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. 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

  2. Adverse Effect [ Time Frame: Through study completion, an average of 1 months ]
    Incidence of Treatment-related adverse Events

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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;

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 identifier (NCT number): NCT04110093

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Department of Medical Oncology, Shanghai Changzheng Hospital Recruiting
Shanghai, China
Contact: Zhan Wang    +86-13916229609   
Principal Investigator: Yuan-Sheng Zang         
Sponsors and Collaborators
Shanghai Changzheng Hospital
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Responsible Party: Yuan-Sheng Zang, Head of Medical Oncology Department, Shanghai Changzheng Hospital 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
microsatellite stable
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases