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NCT04806243 Clinical Trial

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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04806243
Other study ID # NFEC-2021-010
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 6, 2021
Est. completion date January 1, 2022

Study information
Verified date April 2021
Source Nanfang Hospital of Southern Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 69
Est. completion date January 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Not convenient to disclose Exclusion Criteria: - Not convenient to disclose

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Regorafenib Pill&Camrelizumab
Regorafenib,80 mg,QD,Q3w Camrelizumab,200 mg,IV,Q3w

Locations
Country Name City State
China NanFang Hospital of Southern Medical University Guangzhou Guangdong

Sponsors (2)
Lead Sponsor Collaborator
Nanfang Hospital of Southern Medical University Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary os(overall survival) overall survival 21 days
Secondary PFS(progression-free survival) progression-free survival 21 days
Secondary TTP(Time-To-Progression) Time-To-Progression 21 days
Secondary ORR(Overall Response Rate) Overall Response Rate 21 days
Secondary DCR(disease control rate) disease control rate 21 days
Secondary DoR Duration of Response 21 days
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