SBRT+TACE+Sorafenib Vs Sorafenib in the Treatment of uHCC With PVTT
NCT ID: NCT04387695
Last Updated: 2023-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
54 participants
INTERVENTIONAL
2020-04-30
2023-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SBRT + TACE + Sorafenib
SBRT sequential TACE combined with Sorafenib
SBRT+TACE+Sorafenib
SBRT first for the PVTT +TACE for HCC within a week next +Sorafenib with 2 weeks later
Sorafenib
Sorafenib 800 mg/day orally
Sorafenib
Sorafenib 800 mg/day orally
Interventions
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SBRT+TACE+Sorafenib
SBRT first for the PVTT +TACE for HCC within a week next +Sorafenib with 2 weeks later
Sorafenib
Sorafenib 800 mg/day orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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First Affiliated Hospital of Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Jun-hui Sun, MD,PH.D
Role: STUDY_DIRECTOR
First Affiliated Hospital of Zhejiang University
Locations
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The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HEPIC2001
Identifier Type: -
Identifier Source: org_study_id
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