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

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.

Study Overview

• Status: Recruiting
• Conditions: HCC; Hepatocellular Carcinoma; Peritoneal Metastasis; Hyperthymic
• Intervention / Treatment: Procedure: mitomycin C-based hyperthermic intraperitoneal chemotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Jiwei Huang, Professor; Phone Number: +86 18980606725; Email: huangjiwei@wchscu.cn

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Hospital
      • Contact: Jiwei Huang, Professor; Phone Number: +86 18980606725; Email: huangjiwei@wchscu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIPEC group	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.
No Intervention: non-HIPEC group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrence-free-survival	the time from the first administration to the date of first recurrence, including local recurrence and PM and distant metastasis, or death for any cause.	2years

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: September 10, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 16, 2022

Study Record Updates

• Last Update Posted (Actual): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Neoplastic Processes; Carcinoma; Carcinoma, Hepatocellular; Neoplasm Metastasis; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Alkylating Agents; Antibiotics, Antineoplastic; Mitomycins; Mitomycin
• Other Study ID Numbers: JHuang

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No