Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer

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

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 Overview

• Status: Unknown
• Conditions: Colorectal Cancer; Immunotherapy
• Intervention / Treatment: Drug: Regorafenib and PD-1 inhibitor

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Department of Medical Oncology, Shanghai Changzheng Hospital
    • Contact: Zhan Wang; Phone Number: +86-13916229609; Email: 13916229609@139.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission.	Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months
Progress Free Survival	Time from treatment beginning until disease progression	Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Time from treatment beginning until death from any cause	From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months
Adverse Effect	Incidence of Treatment-related adverse Events	Through study completion, an average of 1 months

Collaborators and Investigators

• Sponsor: Shanghai Changzheng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: September 28, 2019
• First Submitted That Met QC Criteria: September 28, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Immunotherapy; Colorectal Cancer; Regorafenib; microsatellite stable; Nivoluamb
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immune Checkpoint Inhibitors
• Other Study ID Numbers: CZ-REGONIVO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No