BCLC Stage C Hepatocellular Carcinoma
Conditions
Keywords
BCLC Stage C, Hepatocellular Carcinoma, Transarterial Chemoembolization, Sorafenib, Tilelizumab
Brief summary
According to the BCLC staging system treatment recommendation, systemic treatment is recommended for patients in BCLC stage C, and TACE and systemic treatment are recommended for patients in this stage. Studies have shown that TACE combined with sorafenib therapy has shown effectiveness in the treatment of advanced liver cancer, and PD-1 inhibitors have also shown effectiveness in the treatment of advanced liver cancer. Therefore, in order to improve the survival benefit of BCLC stage C liver cancer patients, this clinical study was designed to evaluate the effectiveness and safety of TACE combined with sorafenib and tislelizumab in the treatment of BCLC stage C liver cancer patients.
Interventions
DRUGSorafenib
Sorafenib should be administered 400 mg twice /day orally within 1 week after the first TACE
PROCEDURETACE
TACE first ,and more TACE could be performed when it is necessary.
DRUGTilelizumab
Tilelizumab 240mg per 3weeks ivgtt within 1 week after the first TACE
Sponsors
First Affiliated Hospital of Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Child-Pugh score≤ 7 * HCC diagnosed by biopsy or by the noninvasive criteria of the Chinese Liver Cancer Guideline 2019 * the primary HCC being in BCLC C stage according to NCCN guideline * No previous systemic therapy for HCC
Exclusion criteria
* Diffuse HCC * Uncontrolled ascites of hepatic encephalopathy * Prior liver transplantation * Positive for human immunodeficiency virus * Active gastric or duodenal ulcer * Other uncontrolled comorbidities or malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year survival rate | at 1 year after enrolled | 1-year survival rate assessed by Kaplan-Meier analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression | at 12 weeks and up to 2 years after enrolled | Time to progression assessed by independent radiologic review according to mRECIST criteria |
| Progression free survival | at 12 weeks and up to 2 years after enrolled | Progression free survival assessed by independent radiologic review according to mRECIST criteria |
| Objective response rate | at 12 weeks and up to 2 years after enrolled | Objective response rate assessed by independent radiologic review according to mRECIST criteria |
| Disease control rate | at 12 weeks and up to 2 years after enrolled | Disease control rate assessed by independent radiologic review according to mRECIST criteria |
Countries
China
Contacts
Primary ContactJun-hui Sun, MD,PH.D
Backup ContactTong-yin Zhu, MD
Outcome results
None listed