A Trial to Compare Surgery With Sorafenib for Hepatic Celluler Cancer With Portal Vein Tumor Thrombosis
NCT ID: NCT03178656
Last Updated: 2017-12-21
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
PHASE4
54 participants
INTERVENTIONAL
2016-12-15
2019-12-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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PVTT WITH SORAFENIB
AASLD recommend therapy:
sorafenib tablet, 400mg, bid.
Sorafenib
continuous application of the drugs
PVTT WITH OPERATION
patients suitable for surgery
surgery
curative resection
Interventions
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Sorafenib
continuous application of the drugs
surgery
curative resection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
3\. Patients with a solitary tumor or multiple tumor which are resectable. 4. Patients without Hepatic vein or bile duct invasion and extrahepatic metastasis.
5\. Patients without surgical contraindication. 6. Patients with Child A or B liver function and indocyanine green retention rate at 15min (ICGR15) \< 10% before treatment.
7\. Laboratory examination: haemoglobin (Hb)\>100g/L, white blood cell (WBC) \> 3000/mL, PLT \> 8×10\*10/L before treatment.
8\. Patients without severe esophagealgastric varices before treatment. 9. Patients with HBV，HBV DNA≤100, 000 copy/mL. 10. All of the patients has written consent for this research.
Exclusion Criteria
2.Patients with surgical contraindication. 3.Patients with Child C grade liver function before treatment. 4.Patients with other malignancy. 5.Patients treated with hepatic resection or TACE before this treatment. 6.Patients with severe esophagealgastric varices or refractory ascites or coagulation dysfunction before treatment.
20 Years
75 Years
ALL
No
Sponsors
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Huazhong University of Science and Technology
OTHER
Responsible Party
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Xiaoping Chen
Professor
Locations
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Hepatic surgery center, Tong ji Hospital
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Xiaoping Chen, Doctor
Role: primary
Qiong Gong, Doctor
Role: backup
Other Identifiers
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chenxp007
Identifier Type: -
Identifier Source: org_study_id