Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer

Recruiting now · Phase 2

Conditions studied: Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

In brief

Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer

Key facts

Study ID

NCT05200260

Run by

Shanghai Gynecologic Oncology Group

People needed

220

Starts

2022-07-13

Expected to finish

2027-06-01

Last updated by the study team

2025-02-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• white blood cells >3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
• 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,
• 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.

You may not qualify if…

• 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 is running

• The First People's Hospital of Foshan — Foshan, China (enrolling)
• Sun Yet-Sen University Cancer Center — Guangzhou, China (enrolling)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, China (enrolling)
• Zhejiang Cancer Hospital — Hangzhou, China (enrolling)
• The First Affiliated Hospital of University of Science and Technology of China — Hefei, China (enrolling)
• Fudan University Cancer Hospital — Shanghai, China (enrolling)
• Obstetrics and Gynecology Hospital of Fundan University — Shanghai, China (enrolling)
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (enrolling)
• Zhongshan Hospital, Fudan University — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.