Hyperthermic Intraperitoneal ChemotherapyNCT06247293
Surgical Resection Combined With Intraperitoneal Hyperthermic Chemotherapy
An observational study of Hyperthermic Intraperitoneal Chemotherapy and Hepatocellular Carcinoma, run by Zhujiang Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperthermic Intraperitoneal Chemotherapy, Hepatocellular Carcinoma, Ruptured Liver
- What is being tested?
- intraperitoneal hyperthermic perfusion chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- according to the clinical diagnostic criteria of primary liver cancer (2022 edition) or confirmed by pathology/cytology;
- preoperative diagnosis of rupture and hemorrhage of liver cancer by clinical manifestation, examination and imaging;
- Age 18-80 years;
- 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;
- ECOG-PS score of 0-1;
- without other neoplastic diseases;
- Sign and perfect the informed consent form before operation;
- without postoperative liver failure, without major complications such as massive hemorrhage, purulent infection and multiple organ failure, and without discharge from hospital.
Who cannot join
- having other active malignant tumor;
- the expected survival time is less than 3 months;
- Child-pugh class C, complicated with severe organic disease of important organs, complicated with severe cirrhosis.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Retrospective Study of Surgical Resection Combined With Intraperitoneal Hyperthermic Chemotherapy in the Treatment of Ruptured Hepatocellular Carcinoma
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.
Read the 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.
- Being tested
- intraperitoneal hyperthermic perfusion chemotherapy
- Keywords
- ruptured and bleeding of Hepatocellular carcinoma, Hyperthermic intraperitoneal chemotherapy, recurrence-free survival
- Medical subject headings
- Carcinoma, Hepatocellular, Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraperitoneal hyperthermic perfusion chemotherapyProcedure or surgery
Also called simple surgical resection, Hepatic artery embolization
（1）Partial hepatectomy: The reasonable resection method was selected according to the tumor location, residual liver volume and the operation process. The tumor margin should be more than 1 cm, the abdominal cavity was flushed with sterile warm distilled water. In the control group,1-2 abdominal drainage tubes were placed on the hepatic cross-section, in the exposed group,4 abdominal perfusion tubes were placed in the right hepatic apex, splenic fossa, left and right pelvic cavity to perform HIPEC postoperatively.
(2) HIPEC: Temperature setting:43 °C perfusion time:60 min, perfusion speed:400-600 mL/min ,perfusion volume:3000 mL.
（3）Hepatic artery embolization：Through the common femoral artery, the catheter passed through the abdominal aorta, celiac trunk, the common hepatic artery and the inherent hepatic artery to the blood supply target artery of liver cancer. The embolic agent Lipiodol was mixed and injected to embolize the bleeding artery to stop bleeding.
| Study group | Role | What they receive |
|---|---|---|
| Surgical resection combined with intraperitoneal hyperthermic perfusion chemotherapy | Surgical resection combined with intraperitoneal hyperthermic perfusion chemotherapy Receives: Procedure: intraperitoneal hyperthermic perfusion chemotherapy | |
| simple surgical resection | Control group: simple surgical resection Receives: Procedure: intraperitoneal hyperthermic perfusion chemotherapy | |
| other | imple interventional hemostasis group Receives: Procedure: intraperitoneal hyperthermic perfusion chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-abdominal recurrence-free survival (RFS)
Intra-abdominal recurrence-free survival (RFS):the time from surgical resection patients with HCC until the detection of intra-abdominal recurrence or metastasis or the end of the observation period, based on postoperative follow-up test criteria and imaging findings(2 years)
Measured: 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 (2)
Overall Survival (OS)
Overall Survival (OS): time from partial hepatectomy for HCC until death from any cause or end of observation period(2 years)
Measured: time from partial hepatectomy for HCC until death from any cause or end of observation period(2 years)
survival rate
defined as 1-month,3-month,6-month, 1-year,2-year survival rate
Measured: time from partial hepatectomy for HCC until death from any cause or end of observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Feb 2024 (estimated)
- Primary completion25 Feb 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperthermic Intraperitoneal ChemotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mingxin Pan, Prof., Principal investigator, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247293
- Sponsor's protocol ID
- 2023-KY-078-02
- Status last verified
- Jun 2023
- First submitted
- 11 Aug 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of Surgical Resection Combined With Intraperitoneal Hyperthermic Chemotherapy in the Treatment of Ruptured Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06247293
- Acronym / sponsor ID
- 2023-KY-078-02
- Keywords
- ruptured and bleeding of Hepatocellular carcinoma, Hyperthermic intraperitoneal chemotherapy, recurrence-free survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 25 Feb 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surgical resection combined with intraperitoneal hyperthermic perfusion chemotherapy | – | Procedure: intraperitoneal hyperthermic perfusion chemotherapySurgical resection combined with intraperitoneal hyperthermic perfusion chemotherapy |
| simple surgical resection | – | Procedure: intraperitoneal hyperthermic perfusion chemotherapyControl group: simple surgical resection |
| other | – | Procedure: intraperitoneal hyperthermic perfusion chemotherapyimple interventional hemostasis group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- according to the clinical diagnostic criteria of primary liver cancer (2022 edition) or confirmed by pathology/cytology;
- preoperative diagnosis of rupture and hemorrhage of liver cancer by clinical manifestation, examination and imaging;
- Age 18-80 years;
- 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;
- ECOG-PS score of 0-1;
Key exclusion criteria (3 listed)
- having other active malignant tumor;
- the expected survival time is less than 3 months;
- Child-pugh class C, complicated with severe organic disease of important organs, complicated with severe cirrhosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intraperitoneal hyperthermic perfusion chemotherapyAlso: simple surgical resection, Hepatic artery embolization（1）Partial hepatectomy: The reasonable resection method was selected according to the tumor location, residual liver volume and the operation process. The tumor margin should be more than 1 cm, the abdominal cavity was flushed with sterile warm distilled water. In the control group,1-2 abdominal drainage tubes were placed on the hepatic cross-section, in the exposed group,4 abdominal perfusion tubes were placed in the right hepatic apex, splenic fossa, left and right pelvic cavity to perform HIPEC postoperatively. (2) HIPEC: Temperature setting:43 °C perfusion time:60 min, perfusion speed:400-600 mL/min ,perfusion volume:3000 mL. （3）Hepatic artery embolization：Through the common femoral artery, the catheter passed through the abdominal aorta, celiac trunk, the common hepatic artery and the inherent hepatic artery to the blood supply target artery of liver cancer. The embolic agent Lipiodol was mixed and injected to embolize the bleeding artery to stop bleeding. | Procedure or surgery | Surgical resection combined with intraperitoneal hyperthermic perfusion chemotherapy, other, simple surgical resection |
Primary outcome
Intra-abdominal recurrence-free survival (RFS)
Time frame: 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)
Intra-abdominal recurrence-free survival (RFS):the time from surgical resection patients with HCC until the detection of intra-abdominal recurrence or metastasis or the end of the observation period, based on postoperative follow-up test criteria and imaging findings(2 years)
2 secondary outcomes
Overall Survival (OS)
Time frame: time from partial hepatectomy for HCC until death from any cause or end of observation period(2 years)
survival rate
Time frame: time from partial hepatectomy for HCC until death from any cause or end of observation period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mingxin Pan, Prof. principal investigator
Southern Medical University, China
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperthermic Intraperitoneal Chemotherapy and Hepatocellular Carcinoma, run by Zhujiang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingxin Pan, Prof. (18928918216 ext. 189289, pmxwxy@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-abdominal recurrence-free survival (RFS) (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.