Status:
UNKNOWN
SBRT+TACE+Sorafenib Vs Sorafenib in the Treatment of uHCC With PVTT
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Conditions:
Unresectable Hepatocellular Carcinoma
Portal Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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) treat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04387695
Start Date
April 30 2020
End Date
August 1 2023
Last Update
February 16 2023
Active Locations (1)
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1
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003