Clinical trial NCT03277716: Microwave Ablation Combined With TACE in the Treatment of Unresectable Huge Hepatocellular Carcinoma Huge
Official title: Effectivity and Safety of Microwave Ablation Combined With Transcatheter Arterial Chemoembolization(TACE) for Huge Unresectable Hepatocellular Carcinoma: a Multicenter Analysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma Non-resectable
Transarterial Chemoembolization
Microwave Ablation
Keywords: Huge hepatocellular carcinoma
Microwave ablation
TACE
Safety
Non-resectable
Treatment
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-09-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Microwave Ablation Combined With TACE in the Treatment of Non-resectable Huge Hepatocellular Carcinoma
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to prospectively evaluate the efficacy and safety of TACE combined with MWA in patients with huge unresectable hepatocellular carcinoma.

Detailed description: Hepatocellular carcinoma (HCC) is the fifth most common cancer worldwide. Despite the widespread application of surveillance programs in high-risk populations, patients continue to present with huge (≥ 10 cm) HCCs.And it's still a challenge to treat huge HCC nowadays.Surgical resection is currently the only curative treatment for huge HCCs ; however, only a minority of patients are candidates for curative resection. Sorafenib is recommended for the treatment of advanced HCCs, including huge HCCs, but the usage is severely limited by high adverse event rates and low efficiency. Thus, transarterial chemoembolization (TACE) is considered the first choice for huge unresectable HCCs. Several studies have concluded that TACE effectively improves the overall survival of patients with huge HCCs. Meanwhile, microwave ablation (MWA) now has been shown to be safe and effective for local tumor control in HCC patients. However, neither MWA nor TACE alone can achieve complete control of large HCCs . Therefore, the combination of TACE and MWA (TACE+MWA) is an appealing approach to treat HCCs. TACE+MWA now has been shown to improve overall survival rates compared with TACE alone in patients with small to large HCCs. But little data is available on TACE+MWA in patients with huge unresectable HCCs. Thus, the study was designed.

Eligibility criteria: Inclusion Criteria:

1. The performance status of Eastern Cooperative Oncology Group (ECOG) must be 0-1
2. The diagnosis of primary hepatocellular carcinoma must be in line with the American Society for the study of liver diseases (AASLD) diagnostic criteria for hepatocellular carcinoma (HCC)
3. Child-Pugh score A or B;
4. Aged from 18 to 75 years;
5. Subjects voluntarily join the study, and signe informed consent;
6. No anti-tumor therapy was received；
7. Meet the following 4 characteristics: A. primary tumor diameter more than or equal to 10cm; B. no more than 3 HCC foci, and the maximum diameter is less than or equal to 5cm; C. with IIa, I or no portal vein tumor thrombus (Cheng's Classification)；D. the tumor could not be surgically removed
8. No extrahepatic metastases

Exclusion Criteria:

1. Abnormal coagulation function: PLT \< 40×109/L, PTA \< 40%;
2. Patients have the past history of liver cancer treatment, such as transplantation, resection, radiotherapy, chemotherapy and so on;
3. Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
4. Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;
5. Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
6. Patients accompanied with other tumors or past medical history of malignancy;
7. Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;
8. Allergic to adriamycin chemotherapy drugs，contrast agent and lipiodol;
9. Patients have poor compliance.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: up to 3 years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: up to 3 years
measure: Adverse event rate
timeFrame: up to 3 years
measure: Distant metastasis-free survival
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute &Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Fuzhou
country: China
facility: The tumor hospital of Fujian Province
state: Fujian
city: Guangzhou
country: China
facility: the First Affiliated Hospital of SunYat-senUniversity
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Hospital of Shenzhen
state: Guangdong
city: Jinan
country: China
facility: The Second Affiliated Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong Province Hospital
state: Shandong
city: Qingdao
country: China
facility: the Affiliated Hospital of Medical College Qingdao University
state: Shandong
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Sun Yat-sen University
name: Weijun Fan, M.D
role: STUDY_CHAIR
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