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

Primary Purpose

Portal Vein Tumor Thrombus

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sorafenib
surgery
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Portal Vein Tumor Thrombus focused on measuring sorafenib, operation

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hepatic surgery center, Tong ji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PVTT WITH SORAFENIB

PVTT WITH OPERATION

Arm Description

AASLD recommend therapy: sorafenib tablet, 400mg, bid.

patients suitable for surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

time to progression
deterioration indicated by complications or metastasis detected by CT, MRI and laboratory examination.

Full Information

First Posted
May 31, 2017
Last Updated
December 19, 2017
Sponsor
Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03178656
Brief Title
A Trial to Compare Surgery With Sorafenib for Hepatic Celluler Cancer With Portal Vein Tumor Thrombosis
Official Title
RCT Research: the Treatment of Hepatic Carcinoma With Portal Vein Branch Tumor Thrombosis (Resection or Sorafenib)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2016 (Actual)
Primary Completion Date
April 15, 2018 (Anticipated)
Study Completion Date
December 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Vein Tumor Thrombus
Keywords
sorafenib, operation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PVTT WITH SORAFENIB
Arm Type
Active Comparator
Arm Description
AASLD recommend therapy: sorafenib tablet, 400mg, bid.
Arm Title
PVTT WITH OPERATION
Arm Type
Experimental
Arm Description
patients suitable for surgery
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Other Intervention Name(s)
control
Intervention Description
continuous application of the drugs
Intervention Type
Procedure
Intervention Name(s)
surgery
Other Intervention Name(s)
trail
Intervention Description
curative resection
Primary Outcome Measure Information:
Title
overall survival of 1 year
Description
including 3, 6, and 12 months overall survival (OS) rate
Time Frame
1 years
Title
overall survival of 3 year
Description
including 1, 2, and 3 years overall survival (OS) rate
Time Frame
3 years
Secondary Outcome Measure Information:
Title
time to progression
Description
deterioration indicated by complications or metastasis detected by CT, MRI and laboratory examination.
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
mortality
Description
death within 30 days after surgery
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiong Gong, Doctor
Phone
+8618086496360
Email
dtjgq486@hust.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoping Chen, Doctor
Phone
+862783665253
Email
chenxp@medmail.com.cn
Facility Information:
Facility Name
Hepatic surgery center, Tong ji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoping Chen, Doctor
Phone
8602783662851
Email
chenxp@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Qiong Gong, Doctor
Phone
8618086496360
Email
dtjgq486@hust.edu.cn
First Name & Middle Initial & Last Name & Degree
peng zhu, doctor

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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