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

Phase 4

• Conditions: Portal Vein Tumor Thrombus
• Interventions: Procedure: surgery; Drug: Sorafenib

• Registration Number: NCT03178656
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-15
• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-05
• Study First Posted: 2017-06-07
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-19
• Last Update Posted: 2017-12-21
• Primary Completion: 2018-04-15
• Study Completion: 2019-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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.

  2. Patients with a solitary tumor or multiple tumor which are resectable. 4. Patients without Hepatic vein or bile duct invasion and extrahepatic metastasis.

  3. Patients without surgical contraindication. 6. Patients with Child A or B liver function and indocyanine green retention rate at 15min (ICGR15) < 10% before treatment.

  4. Laboratory examination: haemoglobin (Hb)>100g/L, white blood cell (WBC) > 3000/mL, PLT > 8×10*10/L before treatment.

  5. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVTT WITH OPERATION	surgery	patients suitable for surgery
PVTT WITH SORAFENIB	Sorafenib	AASLD recommend therapy: sorafenib tablet, 400mg, bid.

Primary Outcome Measures

Name	Time	Method
overall survival of 1 year	1 years	including 3, 6, and 12 months overall survival (OS) rate
overall survival of 3 year	3 years	including 1, 2, and 3 years overall survival (OS) rate

Secondary Outcome Measures

Name	Time	Method
time to progression	3 years	deterioration indicated by complications or metastasis detected by CT, MRI and laboratory examination.

Trial Locations

Locations (1)

Hepatic surgery center, Tong ji Hospital; 🇨🇳 Wuhan, Hubei, China