Administration of Hyperthermic Intraperitoneal Chemotherapy in the General Ward

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2025-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Ovarian cancer is the most lethal gynecologic malignancy. The majority of patients get diagnosed with advanced disease with peritoneal dissemination.It has been demonstrated that the addition of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) to interval debulking surgery can improve the prognosis. The National Comprehensive Cancer Network (NCCN) treatment guideline has recommended HIPEC as a first-line treatment for patients with advanced ovarian cancer. However, the guideline recommended the "Dutch model" of HIPEC, which is limited for routinely being performed in China. So we propose a HIPEC treatment modality, the bedside closed HIPEC in the general ward (C-HIPEC), which is suitable for the clinical characteristics of China. The aim of this study was to evaluate the safety of this model as a way to lay the foundation for subsequent efficacy evaluation and clinical promotion.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Efficacy of Hyperthermic Intraperitoneal Chemotherapy to Ovarian Cancer Patients With Homologous Recombination Repair Defect and Residual: a Prospective Cohort Study

NCT05265117

Ovarian Cancer

UNKNOWN

Evaluating the Efficacy of Hyperthermic Intraperitoneal Treatment to Enhance the Sensitivity of Immune Checkpoint Inhibitor in Patients With Advanced Ovarian Cancer： A Single-arm Study

NCT07068178

HIPEC Ovarian Serous Adenocarcinoma

NOT_YET_RECRUITING PHASE2

Efficacy of HIPEC as NACT and Postoperative Chemotherapy in the Treatment of Advanced-Stage Epithelial Ovarian Cancer

NCT03180177

Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma

UNKNOWN PHASE3

Hyperthermic Intraperitoneal Chemotherapy for Recurrent Ovarian Cancer

NCT02672098

Ovarian Cancer

COMPLETED PHASE1

Secondary Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for PARP Inhibitors Resistance Patients

NCT06544460

Ovarian Cancer

NOT_YET_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The Dutch Model is limited for the following reasons: 1) The HIPEC treatment requires to be done in the operating room, which means the operation time would be lengthened. 2) High rate of exposure to chemotherapeutic drugs among healthcare workers. 3) It has significant safety concerns because it does not take into account racial differences in drug toxicity. This study is an investigator-initiated prospective multicenter feasibility study with a non-inferiority design, so as to provide evidence-based medical evidence for the use of the C-HIPEC model as an alternative to the "Dutch model" in clinical practice in China.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epithelial Ovarian Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients would receive C-HIPEC in the general ward after interval debulking surgery in 24 hours.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

C-HIPEC arm

Infuse paclitaxel (75mg/m\^2) and cisplatin (75mg/m\^2) at 43℃ through the two drainage tubes placed in the upper abdomen, using the two drainage tubes placed in the lower abdomen as the effluent tubes, with an infusion time of 90 minutes and an infusion rate of 500-600 mL/min. The first HIPEC with paclitaxel should be performed within 24 hours after cytoreductive surgery. The second HIPEC with cisplatin should be performed 24 hours after the completion of the first HIPEC. Intravenous sedatives such as diazoxide, or propofol at 2-6 ml/h should be administered during HIPEC treatment with continuous intravenous infusion by a pump，or intramuscular injection of 50 mg of pethidine.

Group Type EXPERIMENTAL

China Hyperthermic Intraperitoneal Chemotherapy(C-HIPEC)

Intervention Type PROCEDURE

The C-HIPEC would be performed at bedside in the general ward within 24 hours after surgery. The HIPEC treatment instruments are BR-TRG-II system, which can control the temperature stably to 43℃±0.1℃.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

China Hyperthermic Intraperitoneal Chemotherapy(C-HIPEC)

The C-HIPEC would be performed at bedside in the general ward within 24 hours after surgery. The HIPEC treatment instruments are BR-TRG-II system, which can control the temperature stably to 43℃±0.1℃.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Pathologically confirmed primary epithelial ovarian, fallopian tube, and primary peritoneal cancers in FIGO stages III-IV.
2. Previous neoadjuvant chemotherapy with platinum + vincristine and ≤ 4 courses of neoadjuvant chemotherapy.
3. The residual tumor diameter is ≤1 cm after interval debulking surgery, and the reason for receiving IDS is that the patient cannot tolerate PDS due to the poor condition or the PDS cannot achieve optimal cytoreduction due to high tumor burden.
4. Age from 18 to 70 years.
5. Bone marrow reserve was well functioning. Leukocytosis ≥ 3.0×10\^9/L, neutrophilic granulocyte ≥ 1.5 × 10\^9/L, platelet count ≥ 100 × 10\^9/L, and hemoglobin ≥ 80 g/L.
6. Organs work well. AST ≤ 2.5 × ULN, ALT ≤ 2.5 × upper limit of normal(ULN), total serum bilirubin ≤ 1.5 × ULN, and creatinine ≤ 1.5 × ULN.
7. ECOG score 0-1.
8. Patients voluntarily sign an informed consent form

Exclusion Criteria

1. Patients diagnosed with other malignant tumors within 5 years (excluding skin and thyroid cancers).
2. Patient is allergic to erythroxylanes.
3. Patients treated with anticancer drugs in other clinical trials.
4. High risk of anastomotic fistula or intestinal obstruction assessed during interval debulking surgery.
5. Any situation of disease instability or potentially impact safety and adherence of patient.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No