Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer

NCT04110093 | Unknown Phase 1

• 1 other identifier: CZ-REGONIVO
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Colorectal Cancer; Immunotherapy

Keywords

Colorectal Cancer; Immunotherapy; Regorafenib; Nivoluamb; microsatellite stable

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Overall Survival

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

• Adverse Effect

  Through study completion, an average of 1 months

Study Arms (1)

Immunotherapy Combination treatment

EXPERIMENTAL

All colorectal cancer patients received regorafenib plus PD-1 inhibitor

Drug: Regorafenib and PD-1 inhibitor

Interventions

Regorafenib and PD-1 inhibitor 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).

Immunotherapy Combination treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient still has standard treatment therapy based on NCCN guidance;
• Patient can not comply with research program requirements or follow-up;

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Department of Medical Oncology, Shanghai Changzheng Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

regorafenib; Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Medical Oncology Department

Study Record Dates

• First Submitted: September 28, 2019
• First Posted: October 1, 2019
• Study Start: March 1, 2019
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: December 30, 2020

Record last verified: 2020-12

Locations

CN (1)