Clinical trial NCT02301091: Combine TACE and RFA Versus TACE Alone for HCC With PVTT
Official title: Combine Transcatheter Arterial Embolization and Radiofrequency Ablation Versus Transcatheter Arterial Embolization Alone for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Keywords: HCC PVTT TACE RFA
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-11-25
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether combined radiofrequency ablation and transcatheter chemoembolization (TACE) result in better survival outcomes than TACE alone in patients with HCC and portal vein tumor thrombus.

Detailed description: Hepatocellular carcinoma (HCC) is the sixth most common cancer and the second most common cause of death from cancer globally. Although the development of imaging techniques has improved early HCC diagnosis, portal vein tumor thrombus (PVTT) is still identified in 12.5-39.7% of HCC patients at their initial visits. Patients suffering from extremely aggressive HCC with PVTT have a median survival time of only 2.7-4.0 months if left untreated. The current standard of practice recommends sorafenib, which has been shown to prolong overall survival (OS) by nearly 3 months in advanced HCC patients and by 1.5-3.2 months in those with PVTT.

Transarterial chemoembolization (TACE) is the main treatment modality for unresectable HCC patients. Some recent prospective studies have demonstrated that TACE can serve as a safe and effective procedure in selected HCC patients with PVTT. TACE is recommend for a part of patients with HCC and PVTT by the treatment guidelines in China and Japan. However,due to the poor blood supplement of PVTT,the local control rate of PVTT after TACE treatment is low. Besides,as to some hypovascular intrahepatic tumors, TACE also could not controlled effectively. As regard to the high local control rate of radiofrequency ablation (RFA) for intrahepatic lesions and PVTT reported in some studies, we thus suggested that the combination of TACE and RFA might have higher tumor control rate and survival benefit than TACE alone.

We design this study to compare survival outcomes of TACE plus RFA and TACE alone in patients with HCC and PVTT.A total of 240 patients are needed according to statistician's calculation.They will be divided into two groups randomly by computer after sign the informed consent form.One group of patients received TACE plus RFA and the other group of patients received TACE alone.After treatment,patients will be followed-up on their survival, tumor response and adverse events.

Eligibility criteria: Inclusion Criteria:

* HCC with portal vein tumor thrombus in the first or second branch
* Refused sorafenib or could not tolerate the adverse effect of sorafenib
* A solitary HCC ≤ 5.0 cm in diameter, or multiple HCC ≤ 3 lesions, each ≤ 5.0 cm in diameter
* Eastern Cooperative Oncology Group Performance Status 0-1
* Child-Pugh Score ≤ 8
* A platelet counts of \> 60,000/mm3, hemoglobin\>8.5 g/dL, prothrombin time prolong \<6s
* Albumin \>2.8 g/dL, total bilirubin \<51.3 umol/L; alanine aminotransferase (ALT) and aspartate transaminase（AST）\<5 times of upper limit
* Sign the informed consent.

Exclusion Criteria:

* Presence of extrahepatic metastasis except lymph node metastasis
* The blood supply of tumor lesions is absolutely poor or arterial-venous shunt that TACE can not be performed
* Uncontrolled or refractory ascites, ongoing variceal bleeding or encephalopathy;
* Severe heart, brain or kidney diseases
* Previous or concurrent cancer that is distinct in primary site or histology from HCC
* Pregnant women or lactating women.

Primary outcomes:
measure: Overall survival rates
timeFrame: 1 year
Secondary outcomes:
measure: Progression-free survival rates
timeFrame: 6 months
measure: Response rate of PVTT
timeFrame: 6 months
measure: Number of participants with adverse events
timeFrame: 1 month
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Minimally Invasive Interventional Division, Medical Imaging Center, Sun Yat-sen University Cancer Center,
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ming Zhao, doctor
role: PRINCIPAL_INVESTIGATOR
References: