Surgical Resection Combined With Intraperitoneal Hyperthermic Chemotherapy

Last updated: January 30, 2024
Sponsor: Zhujiang Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Liver Disease

Fever

Liver Cancer

Treatment

intraperitoneal hyperthermic perfusion chemotherapy

Clinical Study ID

NCT06247293
2023-KY-078-02
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 clinicalmanifestation, examination and imaging;
  3. Age 18-80 years;
  4. Child-pugh class A or class B after liver protection and albumin correction, withoutsevere 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 massivehemorrhage, purulent infection and multiple organ failure, and without discharge fromhospital.

Exclusion

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.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: intraperitoneal hyperthermic perfusion chemotherapy
Phase:
Study Start date:
February 01, 2024
Estimated Completion Date:
March 31, 2024

Study 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.