Combining surgery with targeted therapy for advanced ovarian cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the optimal timing of surgery in conjunction with maintenance therapies, specifically Bevacizumab and PARP inhibitors, for patients diagnosed with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma. The study aims to determine the best approach to integrate primary debulking surgery and neoadjuvant chemotherapy to improve patient outcomes. Participants will undergo thorough eligibility assessments, including imaging studies and genetic testing, to ensure they meet the criteria for effective treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Females aged ≥ 18 years.
* Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma
* Low, Middle tumor burden and high tumor burden with cPCI score ≤ 12 based on pre-operative CT or PET/CT examination
* Complete cytoreduction can be achieved based on CT or PET/CT examination
* Patients must agree to undergo BRCA (breast cancer gene) and HRD (homologous recombination deficiency) testing
* Performance status (ECOG 0-2)
* Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent surgery:

  1. white blood cells \>3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
  2. serum creatinine \<1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockroft-Gault formula or to local lab measurement,
  3. serum bilirubin \<1.25 x UNL, AST(SGOT) and ALT(SGPT) \<2.5 x UNL.
* Comply with the study protocol and follow-up.
* Patients who have given their written informed consent.

Exclusion Criteria:

* Non-epithelial ovarian malignancies and borderline tumors
* Low grade ovarian cancer
* Mucinous ovarian cancer
* Complete cytoreduction cannot be achieved according to preoperative evaluation, including pulmonary and hepatic parenchymal metastases, unresectable extensive pleural metastases, multiple thoracic lymph nodes metastases, brain or bone metastases
* Patient has a known hypersensitivity to the components of olaparib/bevacizumab or its excipients
* Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ, thyroid carcinoma, or breast carcinoma (without any signs of relapse or activity, early-stage).
* Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise adherence to the protocol.
* Other conditions, such as religious, psychological, and other factors, that could interfere with the provision of informed consent, compliance to study procedures, or follow-up.

Where it's running

• The First People's Hospital of Foshan
  Foshan, China Recruiting
• Sun Yet-Sen University Cancer Center
  Guangzhou, China Recruiting
• The First Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, China Recruiting
• Zhejiang Cancer Hospital
  Hangzhou, China Recruiting
• The First Affiliated Hospital of University of Science and Technology of China
  Hefei, China Recruiting
• Fudan University Cancer Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Libing Xiang
• Email: xiang.libing@zs-hospital.sh.cn
• Phone: 86 21 64041990

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.