Microwave Ablation Combined With TACE in the Treatment of Unresectable Huge Hepatocellular Carcinoma Huge

Not Applicable

• Conditions: Hepatocellular Carcinoma Non-resectable; Transarterial Chemoembolization; Microwave Ablation
• Interventions: Procedure: TACE; Procedure: MWA; Device: MWA system; Drug: Chemoembolization

• Registration Number: NCT03277716
• Lead Sponsor: Fan Weijun

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.

Study Timeline

• Study First Submitted: 2017-08-06
• Study First Submitted QC: 2017-09-06
• Study First Posted: 2017-09-11
• Study Start: 2017-12-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-06
• Last Update Posted: 2019-05-07
• Primary Completion: 2019-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TACE+MWA	MWA system	Transcatheter arterial chemoembolization combined with microwave ablation: 2-3 times of TACE treatment, then followed by ablation treatment using MWA system.
TACE+MWA	Chemoembolization	Transcatheter arterial chemoembolization combined with microwave ablation: 2-3 times of TACE treatment, then followed by ablation treatment using MWA system.
TACE+MWA	TACE	Transcatheter arterial chemoembolization combined with microwave ablation: 2-3 times of TACE treatment, then followed by ablation treatment using MWA system.
TACE+MWA	MWA	Transcatheter arterial chemoembolization combined with microwave ablation: 2-3 times of TACE treatment, then followed by ablation treatment using MWA system.

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	up to 3 years	Overall survival (OS) will be defined as the elapsed time from the enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will occur every 12 weeks (±1 month) until death or withdrawal of consent from the study.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	up to 3 years	Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per mRECIST) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment.
Adverse event rate	up to 3 years	Adverse event rate will be defined as the rate of patients who developed adverse event.
Distant metastasis-free survival	up to 3 years	Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented distant metastasis (as per RECIST 1.1) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment .

Trial Locations

Locations (10)

Shandong Province Hospital; 🇨🇳 Jinan, Shandong, China

the Affiliated Hospital of Medical College Qingdao University; 🇨🇳 Qingdao, Shandong, China

Cancer Institute &Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

Shenzhen People's Hospital; 🇨🇳 Shenzhen, Guangdong, China

Peking University Hospital of Shenzhen; 🇨🇳 Shenzhen, Guangdong, China

the First Affiliated Hospital of SunYat-senUniversity; 🇨🇳 Guangzhou, Guangdong, China

The Second Affiliated Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China

The First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

The tumor hospital of Fujian Province; 🇨🇳 Fuzhou, Fujian, China

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China