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

NCT ID: NCT05544253

Last Updated: 2022-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-09-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HIPEC group

Group Type: EXPERIMENTAL

mitomycin C-based hyperthermic intraperitoneal chemotherapy

Intervention Type: PROCEDURE

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.

non-HIPEC group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. HCC patients have been diagnosed by NCCN clinical practice guidelines in oncology, Hepatobiliary cancers, version 2.2021.

2. ECOG score of 0-2 points;

3. Child-Pugh class A-B liver function only;

4. Consistent with the diagnosis of srHCC: symptoms: acute abdominal pain and peritonitis; blood routine tests: decrease of erythrocyte count; increase of leucocyte count, especially the proportion of neutrophils; radiological features: contrast materials extravasation from lesions confirmed by abdominal contrast enhanced computed tomography or promethean magnetic resonance imaging; intraoperative findings of tumor rupture and postoperative pathology are more confidently conclusive.

5. Consistent with PM of HCC: histological evaluations: biopsy of peritoneal nodules or ascites cytology or postoperative pathological verification; radiological diagnose: early enhancement and late wash-out radiological property of peritoneal nodule or mutual confirmation by two senior radiologists.

6. All of selections have received open or laparoscopic hepatectomy to reach complete macroscopic resection or less than 2.5mm of residual tumor tissue, which is equal to 0 or 1 degree of completeness of cytoreduction.

7. Patients voluntarily participated and signed the informed consent.

Exclusion Criteria

1. Contraindications of HIPEC, such as: extensive intra-abdominal adhesions caused by various reasons; complete intestinal obstruction; severe kidney insufficiency; myelosuppression caused by previous targeted therapy or own blood system disease; severe cardiovascular system disease; infection, especially abdominal infection; bleeding tendency or coagulation dysfunction; the vital signs are unstable; cachexia;

2. Extraperitoneal metastasis;

3. Patients who refuse to accept clinical trials;

4. Those who are deemed unsuitable for inclusion by the researchers.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jiwei Huang

Department of Liver Surgery and Liver Transplantation Centre

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

West China Hospital

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiwei Huang, Professor

Role: CONTACT

huangjiwei@wchscu.cn

+86 18980606725

Facility Contacts

Jiwei Huang, Professor

Role: primary

huangjiwei@wchscu.cn

+86 18980606725

Other Identifiers

JHuang

Identifier Type: -

Identifier Source: org_study_id