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

NCT03178656 | Unknown Phase 4 DMC

• 1 other identifier: chenxp007
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Portal Vein Tumor Thrombus

Keywords

sorafenib, operation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• time to progression

  3 years

Other Outcomes (1)

• mortality

  30 days

Study Arms (2)

PVTT WITH SORAFENIB

ACTIVE COMPARATOR

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

Drug: Sorafenib

PVTT WITH OPERATION

EXPERIMENTAL

patients suitable for surgery

Procedure: surgery

Interventions

Sorafenib DRUG

continuous application of the drugs

Also known as: control

PVTT WITH SORAFENIB

surgery PROCEDURE

curative resection

Also known as: trail

PVTT WITH OPERATION

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. Patients with a solitary tumor or multiple tumor which are resectable. 4. Patients without Hepatic vein or bile duct invasion and extrahepatic metastasis.
• \. Patients without surgical contraindication. 6. Patients with Child A or B liver function and indocyanine green retention rate at 15min (ICGR15) \< 10% before treatment.
• \. Laboratory examination: haemoglobin (Hb)\>100g/L, white blood cell (WBC) \> 3000/mL, PLT \> 8×10\*10/L before treatment.
• \. 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.

You may not qualify if:

• Patients with multiple tumors or vascular or bile duct invasion or extrahepatic metastasis.
• 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.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Hepatic surgery center, Tong ji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Interventions

Sorafenib; Surgical Procedures, Operative; TNF-Related Apoptosis-Inducing Ligand

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Tumor Necrosis Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Central Study Contacts

Qiong Gong, Doctor

CONTACT

+8618086496360; dtjgq486@hust.edu.cn

Xiaoping Chen, Doctor

CONTACT

+862783665253; chenxp@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 7, 2017
• Study Start: December 15, 2016
• Primary Completion: April 15, 2018
• Study Completion: December 15, 2019
• Last Updated: December 21, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)