NCT03277716

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

Effectivity and Safety of Microwave Ablation Combined With Transcatheter Arterial Chemoembolization(TACE) for Huge Unresectable Hepatocellular Carcinoma: a Multicenter Analysis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Fan Weijun · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma Non-resectable
• Transarterial Chemoembolization
• Microwave Ablation

Interventions

Type	Name	Description
PROCEDURE	TACE	TACE: With the patient under local anesthesia, a 5F French catheter was introduced into the abdominal aorta via the femoral artery using the Seldinger technique. Hepatic arterial angiography was performed using fluoroscopy to guide the catheter into the celiac and superior mesenteric arteries. Then, the feeding arteries, tumor, and vascular anatomy surrounding the tumor were identified. Subsequently, a microcatheter was super-selectively inserted into the feeding arteries. Then, a mixture solution containing chemotherapeutic agents and embolic agents were infused into the artery according to the size and blood supply of the tumors.
PROCEDURE	MWA	MWA: All patients were instructed to fast from all foods for 12 hours preoperatively. During the procedure, a CT scan was used to locate the liver tumors, and to design the optimal puncture needle route. Routine disinfection and local anesthesia was applied around the puncture point, and a 16-gauge microwave antenna was gradually inserted into the tumor along the pre-determined angle. Settings of the MWA parameters depended on the manufacturer's recommendation and our experience.
DEVICE	MWA system	MWA system is a kind of medical treatment instrument to restrain and kill tumor based on microwave heating technique and biology heating effect theory.
DRUG	Chemoembolization	Chemotherapeutic drugs: adriamycin，epirubicin and pirarubicin. Embolic agent: lipiodol and embolic microspherea The mixture solution containing chemotherapeutic drugs and embolic agent were infused into the artery according to by the number and size of the lesions, liver and kidney function of the patient, and blood supply of the tumors.

Timeline

• Start date: 2017-12-01
• Primary completion: 2019-12-30
• Completion: 2021-12-30
• First posted: 2017-09-11
• Last updated: 2019-05-07

Locations

10 sites across 1 country: China