Clinical trial NCT06247293: Surgical Resection Combined With Intraperitoneal Hyperthermic Chemotherapy
Official title: A Retrospective Study of Surgical Resection Combined With Intraperitoneal Hyperthermic Chemotherapy in the Treatment of Ruptured Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperthermic Intraperitoneal Chemotherapy
Hepatocellular Carcinoma
Ruptured Liver
Keywords: ruptured and bleeding of Hepatocellular carcinoma
Hyperthermic intraperitoneal chemotherapy
recurrence-free survival
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From February 2017 to February 2023, patients with ruptured Southern Medical University of hepatocellular carcinoma diagnosed in the Department of Hepatobiliary Surgery of Pearl River Hospital or other hospitals.

Brief summary: Patients with ruptured liver cancer and bleeding after surgical resection were included according to the criteria of admission, and the patients were divided into experimental and control groups. the primary efficacy end point was RFS, and the secondary end point was the rate of abdominal implant metastases and OS.To analyze the efficacy of HIPEC.

Detailed description: Patients with ruptured liver cancer and bleeding after surgical resection were included according to the criteria of admission, and the patients were divided into groups: experimental group: surgical resection combined with intraperitoneal hyperthermic perfusion chemotherapy, and control group: simple surgical resection.

At further follow-up, the primary efficacy end point was time to Recurrence free survival (RFS) ,the time from the patient's treatment until the discovery of abdominal metastases or until the follow-up period, and the secondary end point was the rate of abdominal implant metastases, that is, according to the postoperative follow-up test and imaging findings, the incidence of abdominal implantation and metastasis, until the end of abdominal recurrence or metastasis or observation period. Overall Survival OS and survival rate: the time from the time the patient underwent partial hepatectomy until death from tumor causes or the end of the observation period. To analyze the efficacy of HIPEC.

Eligibility criteria: Inclusion Criteria:

1. according to the clinical diagnostic criteria of primary liver cancer (2022 edition) or confirmed by pathology/cytology;
2. preoperative diagnosis of rupture and hemorrhage of liver cancer by clinical manifestation, examination and imaging;
3. Age 18-80 years;
4. Child-pugh class A or class B after liver protection and albumin correction, without severe heart, lung or renal dysfunction, without absolute contraindication to surgery;
5. ECOG-PS score of 0-1;
6. without other neoplastic diseases;
7. Sign and perfect the informed consent form before operation;
8. without postoperative liver failure, without major complications such as massive hemorrhage, purulent infection and multiple organ failure, and without discharge from hospital.

Exclusion Criteria:

1. having other active malignant tumor;
2. the expected survival time is less than 3 months;
3. Child-pugh class C, complicated with severe organic disease of important organs, complicated with severe cirrhosis.

Primary outcomes:
measure: Intra-abdominal recurrence-free survival (RFS)
timeFrame: the time from surgical resection in patients with HCC until the detection of intra-abdominal recurrence or metastasis or the end of the observation period(2 years)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: time from partial hepatectomy for HCC until death from any cause or end of observation period(2 years)
measure: survival rate
timeFrame: time from partial hepatectomy for HCC until death from any cause or end of observation period
Other outcomes:
Locations:
Study officials:
affiliation: Southern Medical University, China
name: Mingxin Pan, Prof.
role: PRINCIPAL_INVESTIGATOR
References: