Completed

Transcatheter Arterial Chemoembolization Combined With Sorafenib for Unresectable Hepatocellular Carcinoma

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What is being tested

TACE

+ TACE-Sorafenib group

Procedure
Who is being recruted

Adenocarcinoma+8

+ Carcinoma

+ Digestive System Diseases

From 18 to 75 Years
+32 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: January 2010
See protocol details

Summary

Principal SponsorSun Yat-sen University
Last updated: February 11, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2010

Actual date on which the first participant was enrolled.

Hepatocellular carcinoma (HCC) is a common cause of cancer mortality in Asia. Most patients present with intermediate or advanced disease. Percutaneous ethanol injection, radiofrequency ablation, and transcatheter arterial chemoembolization (TACE) are not considered as a curative treatment and have achieved very limited success in eradicating large HCC. Two phase III trials were shown to be efficacious and well-tolerated in patients with advanced HCC. Median overall survival was significantly 2 to 3 months longer in the sorafenib group than that in the placebo. It is interesting to recognize the combined therapeutic effect of TACE with sorafenib. The proposed study will make an important contribution to understanding not only the safety and efficacy of sorafenib in addition to TACE in patients diagnosed with unresectable HCC, but this will also be the first clinical trial prospectively to compare the effectiveness of sorafenib combined with TACE with that of TACE alone in the treatment of unresectable HCC

NCT01833299
Principal SponsorSun Yat-sen University
Last updated: February 11, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaCarcinomaDigestive System DiseasesDigestive System NeoplasmsLiver DiseasesLiver NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialCarcinoma, Hepatocellular

Criteria

14 inclusion criteria required to participate
Adults patients ( 18-75 years of age) with a diagnosis of HCC which is not amenable to surgical resection or local ablative therapy
ECOG performance status (PS) < 2
Histological confirmed HCC or clinical/laboratory diagnosis of HCC or nodules larger than 2 cm with typical vascular features or AFP > 200
No current infections requiring antibiotic therapy
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18 exclusion criteria prevent from participating
Active clinically serious infections ( > CTCAEv3 grade 2)
Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Child-Pugh B & C hepatic impairment
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Transcatheter arterial chemoembolization drugs and dosage:TACE with chemothrapy drugs (E-ADM 50mg, carboplatin 300 mg, MMC 8mg)and followed with embolization with lipiodol and absorbable gelatin sponge particles or polyvinyl alcohol particles.

Group II

Experimental
TACE+sorafinib

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Cancer Centre of Sun Yat-Sen University

Guangzhou, ChinaOpen Cancer Centre of Sun Yat-Sen University in Google Maps
CompletedOne Study Center