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Trial Title:
Safety and Efficacy of Mitomycin C-based HIPEC After srHCC and PM of HCC
NCT ID:
NCT05544253
Condition:
Hepatocellular Carcinoma
Peritoneal Metastasis
Hyperthymic
HCC
Conditions: Official terms:
Carcinoma
Neoplasm Metastasis
Carcinoma, Hepatocellular
Mitomycins
Mitomycin
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
mitomycin C-based hyperthermic intraperitoneal chemotherapy
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.
Arm group label:
HIPEC group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiwei Huang, Professor
Phone:
+86 18980606725
Email:
huangjiwei@wchscu.cn
Start date:
October 1, 2022
Completion date:
September 1, 2024
Lead sponsor:
Agency:
West China Hospital
Agency class:
Other
Source:
West China Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05544253
