NCT05544253

Safety and Efficacy of Mitomycin C-based HIPEC After srHCC and PM of HCC

Safety and Efficacy of Mitomycin C-based Hyperthermic Intraperitoneal Chemotherapy After Spontaneously Ruptured Hepatocellular Carcinoma and Peritoneal Metastasis: a Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Hepatocellular carcinoma (HCC) is featured by the spontaneously rupture when suffering severe cirrhosis and intratumoral overpressure. It is a fatal complication with an acute mortality. Importantly, it is served as an independent risk factor for peritoneal metastasis (PM) of HCC with poor prognosis. The systematic agents effective to extrahepatic lesions confers modest efficacy towards PM. HIPEC, as a novel strategy, has been proved by overwhelming studies that it is effective to peritoneal malignant tumors. However, there is absence of prospective study of HIPEC efficacy towards HCC.

Conditions

• Hepatocellular Carcinoma
• Peritoneal Metastasis
• Hyperthymic
• HCC

Interventions

Type	Name	Description
PROCEDURE	mitomycin C-based hyperthermic intraperitoneal chemotherapy	The patients with srHCC or PM of HCC were randomly allocated to either the HIPEC group or the control group. All of them have received open liver resection and perfusion tubes had been set in the operation. For patients with PM of HCC served operation, we are subject to reach CC score at 0-1 to creating sufficient conditions for HIPEC. Finally, place the HIPEC tubes. Implementation of HIPEC was administered 3times on the 1st, 3rd, 5th days within one week after operation. We used intraperitoneal hyperthermic perfusion device (BR-TRG-IITM, Bao Rui medical corporation, Guangdong, China) to achieve HIPEC. The abdominal temperature was maintained at 43°C (109°F) by circulating heated saline. The perfusion volume was 3000ml of normal saline, and the chemotherapeutic agent of mitomycin C was 10mg for a 1-hour perfusion period.

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2022-09-16
• Last updated: 2022-09-16

Locations

1 site across 1 country: China