Sorafenib VS TACE in HCC Patients With Portal Vein Invasion

NCT01480817 | Terminated Phase 2

• 1 other identifier: STAP
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are going to compare the therapeutic effect of sorafenib and transarterial chemoembolization in advanced hepatocellular carcinoma with major branch of portal vein invasion.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Time to Progression (Efficacy)

  every 6 weeks up to 3 years

Secondary Outcomes (7)

• overall survival

  every 6 weeks up to 3 years

• objective tumor response rate

  every 6 weeks up to 3 years

• objective tumor control rate

  every 6 weeks up to 3 years

• progression-free survival

  every 6 weeks up to 3 years

• the adverse event rate and examine the toxicities

  every 6 weeks up to 3 years

Study Arms (2)

Sorafenib

ACTIVE COMPARATOR

Sorafenib 400mg po bid

Drug: Sorafenib

TACE for HCC with portal vein invasion

EXPERIMENTAL

Antineoplastic agents are directly injected into the hepatic artery, allowing high intratumoral concentrations of drugs and thereby reducing systemic side effects. The mixture of chemotherapeutic agents and iodized oil is almost completely retained in neoplastic nodules and can remain in HCC tissue for a long time. Subsequent mechanical embolization of the artery feeding the neoplasm causes ischemic damage to the tumor and prolongs the duration of the effects of chemotherapeutic agents.

Procedure: TACE for HCC with portal vein invasion

Interventions

Sorafenib DRUG

Sorafenib 400mg po bid

Also known as: Nexavar

Sorafenib

TACE for HCC with portal vein invasion PROCEDURE

The volume of iodized oil ranged from 2 to 12 mL, and the amount of doxorubicin ranged from 10 to 60 mg. Gelatin sponge particles were mixed with mitomycin and contrast material.Cisplatin was infused at the tumor feeder vessels as a solution with a concentration of 0.5 mg/mL at a rate of 5-10 mL/min. The total amount of cisplatin used ranged from 50 to 100 mg depending on the patient's body weight and the level of infusion.

Also known as: TACE

TACE for HCC with portal vein invasion

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> Age \>= 18 years.
• Child-Pugh class A (class B could be included when Childs score is 7).
• Hepatocellular carcinoma with major branch of portal vein invasion on dynamic CT or MRI
• not only newly diagnosed treatment-naive patients,
• but also HCC patients previously treated with other therapies in case of development of major branch of portal vein invasion
• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements:
• White blood cell counts (WBC) \>= 2,000 /μl, Absolute neutrophil count (ANC) \> 1,200/μl
• Hemoglobin \>= 8.0 g/dl
• Platelet count \> 50,000/μl
• Serum creatinine \< 1.7 mg/dl
• Total bilirubin =\< 3.0 mg/dl
• Prothrombin Time (PT)-international normalized ratio (INR) =\< 2.3 or Prothrombin Time (PT)-sec =\< 6 sec
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.

You may not qualify if:

• Child-Pugh score \>= 8.
• Age \< 18 or \>= 80 years.
• ECOG Performance Status \>= 3.
• Recipient of living donor or deceased donor liver transplantation
• Patients unable to understand the contents of informed consent or refuse to sign the informed consent.
• Patients with evidence of uncontrolled or severe medical conditions requiring treatment.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

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

Study Officials

• Jung-Hwan Yoon, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2011
• First Posted: November 29, 2011
• Study Start: June 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 29, 2016

Record last verified: 2013-12

Locations

KR (1)