SBRT+TACE+Sorafenib Vs Sorafenib in the Treatment of uHCC With PVTT
- Conditions
- Unresectable Hepatocellular CarcinomaPortal Vein Thrombosis
- Interventions
- Radiation: SBRT+TACE+Sorafenib
- Registration Number
- NCT04387695
- Lead Sponsor
- First Affiliated Hospital of Zhejiang University
- Brief Summary
To evaluate and compare the efficacy and safety of SBRT sequential TACE combined with sorafenib versus sorafenib alone in the treatment of unreactable HCC with PVTT.
- Detailed Description
HCC Patients classified as BCLC stage C present with PVTT, and the recommended first-line treatment is systemic therapy with sorafenib according to updated Barcelona Clinical Liver cancer (BCLC) treatment algorithms.However, recent data from observational studies suggest that the combination of TACE and SBRT would be as effective as sorafenib.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 54
- Age >18 years
- Child-Pugh score ≤ 7
- Performance status: ECOG score ≤ 2
- HCC diagnosed by biopsy or by the noninvasive criteria of the Chinese Liver Cancer Guideline 2017
- the primary HCC being unresectable (BCLC C stage/ CNLC Ⅲa-b) according to NCCN guideline
- No previous therapy for HCC
- at least one measurable target lesion according to RECIST 1.1
- Adequate hematopoietic function: Hemoglobin ≥ 8.5 g/dL; Absolute neutrophil count ≥ 750/mm3; Platelet count ≥ 50,000/mm3
- Serum total bilirubin ≤ 2 x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 10 x ULN
- Creatinine ≤ 1.5 x ULN
- No plan for pregnancy or breast feeding. Active contraception.
- Willing to give informed consent
- Prior history to or exposure of transarterial chemoembolization, external beam radiation to liver, or sorafenib
- Complete obstruction of hepatic outflow
- Uncontrolled ascites of hepatic encephalopathy
- Prior liver transplantation
- Positive for human immunodeficiency virus (HIV)
- Active gastric or duodenal ulcer
- Other uncontrolled comorbidities or malignancy
- Inability to give informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sorafenib Sorafenib Sorafenib 800 mg/day orally SBRT + TACE + Sorafenib SBRT+TACE+Sorafenib SBRT sequential TACE combined with Sorafenib
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) rate at 12 weeks after randomization Progression is defined as progressive disease (PD) by independent radiologic review according to mRECIST criteria, termination of the assigned treatment, or death from any cause, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons with the intention-to-treat principle.
- Secondary Outcome Measures
Name Time Method Overall patient survival rate up to 2 years after randomization The median overall patient survival rate assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.
Radiologic response rate at 12 weeks after randomization Radiologic response rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate.
Disease control rate at 12 weeks and up to 2 years after randomization Disease control rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate.
Objective response rate at 12 weeks and up to 2 years after randomization Objective response rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate.
Trial Locations
- Locations (1)
The First Affiliated Hospital, College of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China