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A prospective randomized controlled clinical study of cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) in the treatment of advanced epithelial ovarian cancer

A prospective randomized controlled clinical study of cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) in the treatment of advanced epithelial ovarian cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052793
Enrollment
Unknown
Registered
2021-11-05
Start date
2021-11-06
Completion date
Unknown
Last updated
2022-08-16

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

Conditions

Advanced epithelial ovarian cancer

Interventions

Experimental group:CRS + HIPEC 3 times + TC regimen intravenous chemotherapy for 6 cycles
Control group:CRS+TC regimen intravenous chemotherapy for 6 cycles

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Primary epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer at stage III at the time of diagnosis, and no other anti-tumor therapy such as chemotherapy or radiotherapy was performed before the start of the clinical trial; 2. Residual lesions in the abdominal cavity =3.0x10^9/L, neutrophil >= 1.5x10^9/L, platelet count >= 100 x 10^9/L, hemoglobin >= 80 g/L; 6. The organ function is good, and the biochemical examination meets the following conditions: AST <= 2.5xUpper limit of normal value (ULN), ALT <= 2.5xUpper limit of normal value (ULN), serum total bilirubin<=1.5xupper limit of normal (ULN), creatinine<=1.5xupper limit of normal (ULN); 7. Functional status: 0-1 (ECOG); 8. The informed consent of the patient has been obtained.

Exclusion criteria

Exclusion criteria: 1. Extensive adhesions in the abdominal cavity; 2. Patients with other malignant tumors (excluding skin cancer and thyroid cancer) within 5 years; 3. At the same time have other serious diseases that are difficult to control (including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, refractory hypertension, renal insufficiency, uncontrollable infection, etc.); 4. Being treated with anticancer drugs in other clinical trials; 5. Any unstable condition or situation that may jeopardize patient safety and compliance.

Design outcomes

Primary

MeasureTime frame
Blood routine and liver and kidney function tests;Tumor markers;Imaging examination (CT or MRI of abdomen and pelvis, chest X-ray);

Countries

China

Contacts

Public ContactZhou Dan

Beijing Hospital

zhoudan_791124@163.com+86 13522180613

Outcome results

None listed

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