Clinical trial NCT00493402: Different Regimens of Transarterial Chemoembolization for Hepatocellular Carcinoma
Official title: The Efficacy, Safety, and Patient Reported Outcomes of Different Regimens of Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Keywords: Antineoplastic Agents
administration & dosage
Carcinoma, Hepatocellular
Chemoembolization, Therapeutic
Humans
Liver Neoplasms
therapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, China
name: Guangdong Provincial People's Hospital
name: The 458 Hospital of Chinese PLA
name: Kaiping Central Hospital
First posted: 2007-06-28
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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).

Detailed description: Transarterial chemoembolization (TACE) has been recommended as first line non-curative therapy for non-surgical patients with large/multifocal HCC who do not have vascular invasion or extrahepatic spread. There has not been any standardized protocol in the choice of chemotherapeutic agents, dosage, dilution, rate of injection, and time interval between treatments. Similarly, there is no agreement on the choice of embolizing agents, degree of embolization, and whether the chemotherapeutic agent should be given together, or before the embolizing agent.

Comparison(s): In patients with HCC who underwent TACE therapy, stratified by whether they have vascular invasion and tumor size, we compare efficacy, safety, and patient reported outcomes (PRO) of different regimens of TACE.

Regimen 1: lipiodol combined chemotherapy with embolization

Regimen 2: lipiodol combined chemotherapy without embolization

Regimen 3: lipiodol single agent chemotherapy with embolization

Eligibility criteria: Inclusion Criteria:

* 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
  * Absolute neutrophil count (ANC) \> 1,500/mm3
* Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* 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

Primary outcomes:
measure: Overall survival
timeFrame: 3 years
Secondary outcomes:
measure: Time to progression
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Cancer Center, Sun Yat-set University
name: Jin-Qing Li, M.D.
role: PRINCIPAL_INVESTIGATOR
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