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

Primary Purpose

Hepatocellular Carcinoma, Peritoneal Metastasis, Hyperthymic

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
mitomycin C-based hyperthermic intraperitoneal chemotherapy
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • West China HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HIPEC group

non-HIPEC group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 10, 2022
Last Updated
September 14, 2022
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05544253
Brief Title
Safety and Efficacy of Mitomycin C-based HIPEC After srHCC and PM of HCC
Official Title
Safety and Efficacy of Mitomycin C-based Hyperthermic Intraperitoneal Chemotherapy After Spontaneously Ruptured Hepatocellular Carcinoma and Peritoneal Metastasis: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Peritoneal Metastasis, Hyperthymic, HCC

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIPEC group
Arm Type
Experimental
Arm Title
non-HIPEC group
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
mitomycin C-based hyperthermic intraperitoneal chemotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
recurrence-free-survival
Description
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.
Time Frame
2years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HCC patients have been diagnosed by NCCN clinical practice guidelines in oncology, Hepatobiliary cancers, version 2.2021. ECOG score of 0-2 points; Child-Pugh class A-B liver function only; 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. 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. 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. Patients voluntarily participated and signed the informed consent. Exclusion Criteria: 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; Extraperitoneal metastasis; Patients who refuse to accept clinical trials; Those who are deemed unsuitable for inclusion by the researchers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiwei Huang, Professor
Phone
+86 18980606725
Email
huangjiwei@wchscu.cn
Facility Information:
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiwei Huang, Professor
Phone
+86 18980606725
Email
huangjiwei@wchscu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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

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