A Trial to Compare Surgery With Sorafenib for Hepatic Celluler Cancer With Portal Vein Tumor Thrombosis

Study Overview
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Brief Summary
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According to the guidelines recommended, only a few new targeted therapy drugs treatment, such as Sorafenib, is proper. It's 3 year survival rate is only 8% or so. According to our previous study, patients with hepatic carcinoma without portal vein tumor thrombus backbone and the contralateral tumor thrombus applyed tumor excision, along with tumor thrombus, the 3 year survival rate can reach 39.9%, the 5-year survival rate can reach 22.7%, curative effect is obviously better.

Official Title
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RCT Research: the Treatment of Hepatic Carcinoma With Portal Vein Branch Tumor Thrombosis (Resection or Sorafenib)

Conditions
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Portal Vein Tumor Thrombus

Intervention / Treatment
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* Drug: Sorafenib
* Procedure: surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Clinical diagnosis of Hepatic cellular Carcinoma. 2. Patients with Portal Vein Tumor Thrombus (PVTT) of Hepatic cellular Carcinoma (HCC) detected by Serum Alpha Fetoprotein (AFP) and CT or MRI. 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: 1.Patients with multiple tumors or vascular or bile duct invasion or extrahepatic metastasis. 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PVTT WITH SORAFENIB<br>AASLD recommend therapy: sorafenib tablet, 400mg, bid. | Drug: Sorafenib<br>* continuous application of the drugs<br>* Other names: control;|
| Experimental: PVTT WITH OPERATION<br>patients suitable for surgery | Procedure: surgery<br>* curative resection<br>* Other names: trail;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival of 1 year | including 3, 6, and 12 months overall survival (OS) rate | 1 years | 
| overall survival of 3 year | including 1, 2, and 3 years overall survival (OS) rate | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to progression | deterioration indicated by complications or metastasis detected by CT, MRI and laboratory examination. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sorafenib, operation