Different Regimens of Transarterial Chemoembolization for Hepatocellular Carcinoma

NCT00493402 | Completed Phase 3 DMC

• 1 other identifier: hcc-001
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate efficacy, safety, and patient reported outcomes (PRO) of different regimens of transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma (HCC).

Conditions

Hepatocellular Carcinoma

Keywords

Antineoplastic Agents; administration & dosage; Carcinoma, Hepatocellular; Chemoembolization, Therapeutic; Humans; Liver Neoplasms; therapy

Outcome Measures

Primary Outcomes (1)

• Overall survival

  3 years

Secondary Outcomes (1)

• Time to progression

  3 years

Study Arms (3)

combined chemotherapy with embolization

EXPERIMENTAL

chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, with particle embolization.

Procedure: Transarterial chemoembolization (TACE)

combined chemotherapy without embolization

EXPERIMENTAL

chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, without particle embolization.

Procedure: Transarterial chemoembolization (TACE)

single agent chemotherapy with embolization

EXPERIMENTAL

chemotherapy with lipiodol mixed with EADM 50mg, plus particle embolization.

Procedure: Transarterial chemoembolization (TACE)

Interventions

Transarterial chemoembolization (TACE) PROCEDURE

drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, plus particle embolization.

combined chemotherapy with embolization

Eligibility Criteria

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

You may qualify if:

• Adult patients with minimal height of 150cm and minimal weight of 50 KG
• Histological confirmed HCC
• with no previous treatment
• With unresectable tumor
• With solitary or multiple intrahepatic tumor, the diameter of the largest one must larger than 7cm.
• No significant baseline liver dysfunction. Cirrhotic status of Child-Pugh class A only
• No significant renal impairment (creatinine clearance \< 30 mL/minute)
• The following laboratory parameters:
• Platelet count ≥ 60,000/µL
• Hemoglobin ≥ 8.5 g/dL
• Total bilirubin ≤ 1.5 mg/dL
• ASL and AST ≤ 5 x upper limit of normal
• Serum albumin ≥ 35 g/L
• Serum creatinine ≤ 1.5 x upper limit of normal
• INR ≤ 1.5 or a Pt/PTT within normal limits

You may not qualify if:

• Avascular tumor
• Main portal vein obstruction without cavernous transformation
• Evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy
• Obstructive jaundice
• Severe underlying cardiac or renal diseases
• Known or suspected allergy to the investigational agent or any agent given in association with this trial
• Pregnant or breast-feeding patients.
• History of organ allograft
• Active clinically serious infections
• Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Ministry of Health, China: collaborator
• Guangdong Provincial People's Hospital: collaborator
• The 458 Hospital of Chinese PLA: collaborator
• Kaiping Central Hospital: collaborator

Study Sites (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (28)

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MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jin-Qing Li, M.D.

  Cancer Center, Sun Yat-set University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 27, 2007
• First Posted: June 28, 2007
• Study Start: July 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

CN (1)