SBRT+TACE+Sorafenib Vs Sorafenib in the Treatment of uHCC With PVTT

Study Overview
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Brief Summary
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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
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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.

Official Title
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SBRT Sequential TACE Combined With Sorafenib Versus Sorafenib Alone in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus：A Single-center Randomized Controlled Study

Conditions
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Unresectable Hepatocellular Carcinoma, Portal Vein Thrombosis

Intervention / Treatment
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* Radiation: SBRT+TACE+Sorafenib
* Drug: Sorafenib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBRT + TACE + Sorafenib<br>SBRT sequential TACE combined with Sorafenib | Radiation: SBRT+TACE+Sorafenib<br>* SBRT first for the PVTT +TACE for HCC within a week next +Sorafenib with 2 weeks later<br>* Other names: Stereotactic Body Radiation Therapy;|
| Active Comparator: Sorafenib<br>Sorafenib 800 mg/day orally | Drug: Sorafenib<br>* Sorafenib 800 mg/day orally<br>* Other names: Nexavar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) rate | 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. | at 12 weeks after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiologic response rate | Radiologic response rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate. | at 12 weeks after randomization | 
| Overall patient survival rate | The median overall patient survival rate assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons. | up to 2 years after randomization | 
| Objective response rate | Objective response rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate. | at 12 weeks and up to 2 years after randomization | 
| Disease control rate | Disease control rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate. | at 12 weeks and up to 2 years after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular Carcinoma,Portal Vein Tumor Thrombus, Radiation ,Sorafenib