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

NCT05544253 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2022-09-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2024-09-01
Completion
2024-09-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05544253 on ClinicalTrials.gov