Portal Vein Thrombosis, Unresectable Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular Carcinoma,Portal Vein Tumor Thrombus, Radiation ,Sorafenib
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.
Interventions
RADIATIONSBRT+TACE+Sorafenib
SBRT first for the PVTT +TACE for HCC within a week next +Sorafenib with 2 weeks later
DRUGSorafenib
Sorafenib 800 mg/day orally
Sponsors
First Affiliated Hospital of Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactJun-hui Sun, MD,PH.D
Backup ContactTan-yang Zhou, MD,PH.D
Outcome results
None listed