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Sorafenib Combined With Transarterial Chemoembolization in Treating HBV-infected Patients With Intermediate Hepatocellular Carcinoma

Information source: Shandong Cancer Hospital and Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: PHENYTOIN/SORAFENIB [VA Drug Interaction]; Liver Neoplasms; Carcinoma, Hepatocellular; Digestive System Neoplasms; Neoplasms by Site; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; DOXORUBICIN/TRASTUZUMAB [VA Drug Interaction]; HBV

Intervention: Transarterial Chemoembolization (TACE) (Procedure); Sorafenib in combination with TACE (Other)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Shandong Cancer Hospital and Institute

Official(s) and/or principal investigator(s):
Jinlong Song, MD, Principal Investigator, Affiliation: Shandong Cancer Hospital and Institute

Overall contact:
Jinlong Song, MD, Phone: +8653167626411, Email: songjlmd@gmail.com

Summary

Transarterial chemoembolization (TACE) is widely used for unresectable hepatocellular carcinoma (HCC). However, the hypoxia caused by TACE in surviving tumor cell leads to release of angiogenic and growth factors contributing to poor outcome. Sorafenib can block tumor cell proliferation and angiogenesis. The hypothesis is that patients with unresectable HCC may benefit from sorafenib in combination with TACE.

Clinical Details

Official title: Phase II Trail of Sorafenib Combined With Transarterial Chemoembolization in HBV-infected Patients With Intermediate Hepatocellular Carcinoma

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Effectiveness of sorafenib in increasing the effectiveness of transarterial chemoembolization (TACE)

Secondary outcome:

safety of sorafenib in combination with TACE

Survival in the two treatment groups

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients newly diagnosed as HCC according to European Association for Study of the

Liver criteria.

- BCLC stage B

- Child-Pugh class A

- ECOG performance status of 0

- Etiology: Hepatitis B virus(HBV) infection

- Written informed consent (approved by the Institutional Review Board [IRB]obtained

prior to any study specific screening procedures

- Patient must be able to comply with the protocol

- Age 18-80 years

- Haematology: Absolute neutrophil count (ANC) > 1 x 109/L, Platelet count > 40 x 109/L,

Haemoglobin > 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time international normalized ratio < 1. 5

- Biochemistry: Total bilirubin < 2 mg/dL Serum creatinine < 1. 5 x the upper limit of

normal

- Life expectancy of > 3 months

Exclusion Criteria:

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 x the upper

limit of normal

- Other severe concomitant disease that may reduce life expectancy

- uncontrolled hypertension

- Pregnancy (positive serum pregnancy test) or lactation

- Uncontrolled hypertension

- Serious, non-healing wound, ulcer, or bone fracture

- Currently or recent (within the 30 days prior to starting study treatment) treatment

of another investigational drug or participation in another investigational study

- Clinically significant (i. e. active) cardiovascular disease for example

cerebrovascular accidents ( ≤ 6 months prior to study entry), myocardial infarction ( ≤ 6 months prior to study entry), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication

- Evidence of other disease, metabolic dysfunction, physical examination finding, or

clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of Sorafenib/TACE or patient at high risk from treatment complications

Locations and Contacts

Jinlong Song, MD, Phone: +8653167626411, Email: songjlmd@gmail.com

Shandong Cancer Hospital and Institute, Jinan, Shandong 250117, China; Not yet recruiting
Wenbo Shao, MD, Ph D, Phone: +8653167626412, Email: shaowenbomd@gmail.com
Jinlong Song, MD, Principal Investigator
Wenbo Shao, MD, Ph D, Sub-Investigator
Additional Information

Starting date: May 2012
Last updated: April 24, 2012

Page last updated: August 23, 2015

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