Skip to content

A Phase III Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Epithelial Ovarian Cancer After Comprehensive Staging Laparotomy

A Phase III Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Epithelial Ovarian Cancer After Comprehensive Staging Laparotomy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024452
Enrollment
Unknown
Registered
2019-07-12
Start date
2019-07-09
Completion date
Unknown
Last updated
2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epithelial Ovarian Cancer

Interventions

test group:omprehensive staged surgery + HIPECC (3times)+ postoperative systemic chemotherapy (6weeks)
Control group:Comprehensive staged surgery + postoperative systemic chemotherapy (6weeks)

Sponsors

The Fourth Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. In the initial treatment, no chemotherapy, radiotherapy or other anti-tumor treatment is available before the start of the clinical trial; 2. Aged 18 to 70 years; 3. Non-pregnant, lactating women; 4. Imaging (full abdominal enhanced CT or ultrasound) is highly suggestive of ovarian malignancies, CA125 > 300U/mL and / or ascites to find cancer cells; 5. Intraoperative frozen pathology report: epithelial ovarian cancer, the visual stage is between IC1-IIIB, feasible full-stage surgery; 6. The bone marrow reserve function is good, and the blood routine meets the following conditions: white blood cell count >= 3.5x10^9/L, neutrophils >= 1.5x10^9/L, platelet count >= 100x10^9/L, hemoglobin >= 90 g/L; 7. Organ function is good, biochemical examination meets the following conditions: ALT <= 2.5 x upper limit of normal value (ULN), AST <= 2.5 x ULN, serum total bilirubin <= 1.5 x ULN, serum creatinine <= 1.5 × ULN; 8. Functional status: 0-1 (ECOG); 9. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Have a history of other malignant tumors within 5 years; 2. Intraoperative frozen pathology is reported as non-epithelial ovarian cancer, or epithelial ovarian cancer staging outside of IC1-IIIB; 3. At the same time, there are serious or uncontrolled medical diseases and infected people (including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction below 50%, difficult to control high blood pressure, etc.); 4. Patients with seizures requiring treatment (eg steroids or antiepileptic treatment); 5. Patients with severe or uncontrolled mental illness; 6. Drug abuse and medical, psychological or social conditions may interfere with the patient's participation in the study or have an impact on the evaluation of the research results; 7. Any unstable condition or condition that may jeopardize patient safety and compliance; 8. Anticancer drug treatment in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Overall survival (OS);

Secondary

MeasureTime frame
Disease-free survival (DFS);safety;

Countries

China

Contacts

Public ContactHui Zhang

The Fourth Hospital of Hebei Medical University

zhanghui516@126.com+86 13831120917

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026