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

A Prospective, Multicenter, Randomized Phase II Trial on Optimal Timing of Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer

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

The purpose of this trial is to answer the fundamental question 'The Optimal Timing of Surgery' combined with Bevacizumab or Poly-adenosine Ribose Phosphate Inhbitors (PARPi), in the circumstance of primarily diagnosed advanced epithelial ovarian cancer, fallopian tube cancer and primary peritoneal carcinoma.

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.