Clinical trial NCT02004210: A Phase 3 Trial Comparing TACE and TARE in Unilobar Advanced Hepatocellular Carcinoma
Official title: A Randomized, Multi-center, Open Label, Phase 3 Trial Comparing Conventional TACE and Transarterial Radioembolization in Patients With Unilobar Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Keywords: transarterial chemoembolization
transarterial radioembolization
advanced hepatocellular carcinoma
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.

Detailed description: Potentially curative treatments for hepatocellular carcinoma (HCC) include surgical resection, liver transplantation, and local ablative therapy.

However, HCC patients are diagnosed at advanced stages in Korea. Unresectable advanced HCCs are not suitable for other curative therapies. For these patients, the optimal treatment remains largely controversial. As a palliative treatment, the benefit of transarterial chemoembolization (TACE) had been shown in patients with unresectable HCC by several trials. Recently,transarterial radioembolization (TARE) has been introduced for the treatment of advanced HCC. However, the efficacy of TARE compared to TACE is uncertain.

The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.

Eligibility criteria: Inclusion Criteria:

* Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC
* Patients with advanced HCC with unilobar advanaced involvement: right lobe ± S4 segment or left lobe ± S4 segment)
* Patients with single large HCC or multinodular HCC

  * Single \& 5cm \< size \< 15cm
  * 2-5 nodules \& maximal sized 4-15cm \& sum of diameters ≦ 25cm
  * Infiltrative type \& unilobular involvement on liver MRI
  * Segmental or lobar portal vein invasion can be included.
* Age : 20 years to 80 years
* ECOG Performance Status of 0 to 2
* Child-Pugh class A (Child-Pugh score 5-6), B (CP score 7)
* Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:

  * WBC count ≧ 1,000/mm3
  * Absolute neutrophil count \> 500/mm3
  * Hb ≧ 7.0 g/dL
  * Platelet count \> 100,000 /mm3
  * Bilirubin ≦ 3 mg/dL
  * Adequate clotting function: INR ≦ 2.3 or ≦ 6sec

Exclusion Criteria:

* Child-Pugh score ≧ 8
* ECOG Performance Status ≧ 3
* Patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dL
* History of organ allograft
* Patients with uncontrolled co-morbidity which needs treatment
* Patients who have received prior systemic chemotherapy
* Patients who have received Capecitabine within 8 weeks
* Patients with extrahepatic metastasis
* Main portal vein invasion
* Patients with lymph node metastasis
* Bilobar involvement
* Bulk disease(Tumor volume \>70% of the target liver volume, or tumor nodules too numerous to count)
* Pregnancy

Primary outcomes:
measure: Overall survival
timeFrame: every 12 weeks, up to the time of death, up to 12 months
Secondary outcomes:
measure: Progression-Free Survival in the Liver
timeFrame: every 12 weeks, up to the time of death or first documented intrahepatic tumor progression, up to 12 months
measure: Progression-Free Survival Overall
timeFrame: every 12 weeks, up to the time of death or first documented progression, up to 12 months
measure: Overall tumor response assessment
timeFrame: every 12 weeks, up to the time of death or 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jung-Hwan Yoon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: