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

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Regorafenib Pill&Camrelizumab
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Not convenient to disclose

Exclusion Criteria:

  • Not convenient to disclose

Sites / Locations

  • NanFang Hospital of Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Carelizumab Combined With Regorafenib arm

Arm Description

Outcomes

Primary Outcome Measures

os（overall survival）
overall survival

Secondary Outcome Measures

PFS（progression-free survival）
progression-free survival
TTP（Time-To-Progression）
Time-To-Progression
ORR（Overall Response Rate）
Overall Response Rate
DCR（disease control rate）
disease control rate
DoR
Duration of Response

Full Information

First Posted
March 4, 2021
Last Updated
June 28, 2021
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04806243
Brief Title
Carelizumab Combined With Regorafenib in the Treatment of HCC（CARE-2020）
Official Title
A Phase II, Second-line, Single-arm Clinical Trial of Carelizumab Combined With Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 6, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carelizumab Combined With Regorafenib arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Regorafenib Pill&Camrelizumab
Intervention Description
Regorafenib，80 mg，QD，Q3w Camrelizumab，200 mg，IV，Q3w
Primary Outcome Measure Information:
Title
os（overall survival）
Description
overall survival
Time Frame
21 days
Secondary Outcome Measure Information:
Title
PFS（progression-free survival）
Description
progression-free survival
Time Frame
21 days
Title
TTP（Time-To-Progression）
Description
Time-To-Progression
Time Frame
21 days
Title
ORR（Overall Response Rate）
Description
Overall Response Rate
Time Frame
21 days
Title
DCR（disease control rate）
Description
disease control rate
Time Frame
21 days
Title
DoR
Description
Duration of Response
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Not convenient to disclose Exclusion Criteria: Not convenient to disclose
Facility Information:
Facility Name
NanFang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi Li, Master
Phone
020-62787430
Email
nfdoctorlee@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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