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

Portal Vein Tumor Thrombus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03178656
• Other study ID #: chenxp007
• Status: Recruiting
• Phase: Phase 4
• First received: May 31, 2017
• Last updated: December 19, 2017
• Start date: December 15, 2016
• Est. completion date: December 15, 2019

Study information

• Verified date: December 2017
• Source: Huazhong University of Science and Technology
• Contact: Qiong Gong, Doctor
• Phone: +8618086496360
• Email: dtjgq486[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 15, 2019
• Est. primary completion date: April 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Portal Vein Tumor Thrombus
• Thrombosis

Intervention

Drug:
• Sorafenib
continuous application of the drugs

Procedure:
• surgery
curative resection

Locations

Country	Name	City	State
China	Hepatic surgery center, Tong ji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	mortality	death within 30 days after surgery	30 days
Primary	overall survival of 1 year	including 3, 6, and 12 months overall survival (OS) rate	1 years
Primary	overall survival of 3 year	including 1, 2, and 3 years overall survival (OS) rate	3 years
Secondary	time to progression	deterioration indicated by complications or metastasis detected by CT, MRI and laboratory examination.	3 years