Clinical trial NCT01857726: Comparison of TACE Versus TACE/TACI Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
Official title: A Randomized Open Label Pilot Study Comparing Transarterial Chemoembolization Versus Transarterial Chemoembolization/Transarterial Chemoinfusion Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
portal vein invasion
transarterial chemoembolization
transarterial chemoinfusion
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-05-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
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 transarterial chemoembolization with adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion.

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. Especially, HCCs with portal vein invasion are unresectable and they 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 and without portal vein invasion by several trials. In patients with main portal vein invasion, TACE is theoretically contraindicated because of the potential risk of hepatic failure resulting from ischemia after TACE. However, recent studies have revealed that TACE could safely be performed in these patients.

The aim of this study is to compare the efficacy of transarterial chemoembolization (TACE) with adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion (TACI) with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion.

Eligibility criteria: Inclusion Criteria:

* Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC
* Patients with advanced HCC with invasion of major branch(es) of portal vein in the arterial phase of dynamic CT or MRI
* Patients who have received previous local therapy treatments (RFA, PEI, cryoablation, surgery, resection) are eligible
* Age : 18 years to 80 years
* ECOG Performance Status of 0 to 2
* Child-Pugh class A (Child-Pugh score 5-6)
* Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:

  * WBC count \> 2,000/mm3
  * Absolute neutrophil count \> 1,000/mm3
  * Hb ≧ 8.0 g/dL
  * Platelet count ≧ 50,000 /mm3
  * Bilirubin ≦ 3 mg/dL
  * Adequate clotting function: INR \< 2.3 or \< 6sec

Exclusion Criteria:

* Child-Pugh score ≧ 7
* 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 with extrahepatic metastasis

Primary outcomes:
measure: Overall survival
timeFrame: every 12 weeks, up to 48 weeks
Secondary outcomes:
measure: Time-to-progression
timeFrame: every 12 weeks, up to 48 weeks
measure: Progression-free survival
timeFrame: every 12 weeks, up to 48 weeks
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: