Combining surgery with targeted therapy for advanced ovarian cancer treatment
A Prospective, Multicenter, Randomized Phase II Trial on Optimal Timing of Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer
This study is testing the best timing for surgery combined with targeted treatments to see if it helps people with advanced ovarian cancer feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Shanghai Gynecologic Oncology Group Government |
| Drugs / interventions | bevacizumab, chemotherapy |
| Locations | 9 sites (Foshan and 8 other locations) |
| Trial ID | NCT05200260 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 and older with stage IIIC or IV ovarian, fallopian tube, or primary peritoneal cancer who can achieve complete cytoreduction.
Not a fit: Patients with early-stage ovarian cancer or those unable to undergo the required surgical and chemotherapy interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with advanced ovarian cancer.
How similar studies have performed: Other studies have shown promising results with similar combinations of surgery and targeted therapies in advanced ovarian cancer, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Foshan and 8 other locations
- 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)
- Obstetrics and Gynecology Hospital of Fundan University — Shanghai, China (Recruiting)
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)
- Zhongshan Hospital, Fudan University — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Libing Xiang
- Email: xiang.libing@zs-hospital.sh.cn
- Phone: 86 21 64041990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.