Carelizumab Combined With Regorafenib in the Treatment of HCC（CARE-2020）

June 28, 2021 updated by: Nanfang Hospital of Southern Medical University

A Phase II, Second-line, Single-arm Clinical Trial of Carelizumab Combined With Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma

To investigate the efficacy and safety of carelizumab combined with regorafenib in second-line treatment for patients with primary hepatocellular carcinoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Currently, there is little experience in the application of targeted drugs combined with immunotherapy. Through this study, we hope to explore the optimal population for the use of carelizumab combined with regorafenib in the second-line treatment of hepatocellular carcinoma (HCC), as well as the efficacy and safety.

This research is a single-center trials phase II second-line, single arm, explore the clinical outcome of treatment.

Study Type

Interventional

Enrollment (Anticipated)

69

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital of Southern Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Not convenient to disclose

Exclusion Criteria:

  • Not convenient to disclose

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Carelizumab Combined With Regorafenib arm
Drug: Regorafenib Pill&Camrelizumab
Regorafenib，80 mg，QD，Q3w Camrelizumab，200 mg，IV，Q3w

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
os（overall survival）
Time Frame: 21 days
overall survival
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS（progression-free survival）
Time Frame: 21 days
progression-free survival
21 days
TTP（Time-To-Progression）
Time Frame: 21 days
Time-To-Progression
21 days
ORR（Overall Response Rate）
Time Frame: 21 days
Overall Response Rate
21 days
DCR（disease control rate）
Time Frame: 21 days
disease control rate
21 days
DoR
Time Frame: 21 days
Duration of Response
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 6, 2021

Primary Completion (ANTICIPATED)

January 1, 2022

Study Completion (ANTICIPATED)

January 1, 2022

Study Registration Dates

First Submitted

March 4, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (ACTUAL)

March 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 30, 2021

Last Update Submitted That Met QC Criteria

June 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2021-010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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