Hepatocellular Carcinoma
Conditions
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.
Interventions
DRUGRegorafenib Pill&Camrelizumab
Regorafenib，80 mg，QD，Q3w Camrelizumab，200 mg，IV，Q3w
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Nanfang Hospital, Southern Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Not convenient to disclose
Exclusion criteria
* Not convenient to disclose
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| os（overall survival） | 21 days | overall survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS（progression-free survival） | 21 days | progression-free survival |
| TTP（Time-To-Progression） | 21 days | Time-To-Progression |
| ORR（Overall Response Rate） | 21 days | Overall Response Rate |
| DCR（disease control rate） | 21 days | disease control rate |
| DoR | 21 days | Duration of Response |
Countries
China
Outcome results
None listed