Ovarian cancer
Conditions
Interventions
Patients with nest cancer (exposure group: Group A: Patients with BRCA1/2 mutations were maintained with olaparib monotherapy or olaparib combined with bevacizumab.) Group B: Patients with BRCA1/2 wil
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Newly diagnosed and treated ovarian cancer; 2.Pathologically confirmed as advanced serous or endometrioid carcinoma, or primary peritoneal carcinoma or fallopian tube carcinoma; 3.Disease staged as II–IV, with surgical treatment performed after evaluation; 4.Presence of gBRCA1/2m, sBRCA1/2m, or non-BRCA1/2m homologous recombination deficiency (HRD); 5.Underwent cytoreductive surgery, regardless of postoperative residual tumor status; 6.Achieved complete response (CR) or partial response (PR) based on RECIST 1.1 criteria following platinum-based chemotherapy; 7.Received first-line maintenance therapy with PARP inhibitors (PARPi); 8.The participant and their family fully understand the study protocol and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Pathologically confirmed non-high-grade serous carcinoma, endometrioid carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma; 2.Deemed ineligible for surgical treatment upon evaluation; 3.History of other malignant tumors within the past five years and/or prior treatment with PARP inhibitors (PARPi) before study enrollment; 4.Patients who decline first-line maintenance therapy with PARPi; 5.Severe psychiatric disorders; 6.Severe cardiovascular disease, uncontrolled infections, or other uncontrolled comorbidities; 7.Patients or their legally authorized representatives unwilling to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease progression under PARPi maintenance treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactWang Xipeng
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed