Biomarker-driven Targeted Therapy in Patients With Recurrent Platinum-resistant Epithelial Ovaria… (NCT05044871) | Clinical Trial Compass
CompletedPhase 2
Biomarker-driven Targeted Therapy in Patients With Recurrent Platinum-resistant Epithelial Ovarian Cancer
China108 participantsStarted 2022-07-22
Plain-language summary
This study is an open-label, multicenter, umbrella study aimed to evaluate the combined, biomarker-driven, targeted treatment efficiency of Pamiparib, Bevacizumab, Tislelizumab, and Nab-paclitaxel in patients with platinum-resistant recurrent ovarian cancer (PROC).
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Voluntary participation and signing of informed consent
✓. Age ≥ 18 years;
✓. the Eastern United States cancer cooperation group (ECoG) score 0-1;
✓. Platinum-resistant recurrent ovarian cancer (PROC): the patient was diagnosed with platinum-resistant recurrence for the first time. PROC refers to the disease progression that occurred \< 6 months after the last dose of platinum-based chemotherapy. Imaging-based evaluation for the latest recurrence/progression before enrollment was required;
✓. Malignant epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by histology or cytology, including high-grade serous cancer, low-grade serous cancer, endometrioid cancer, clear cell cancer, mucinous cancer, and carcinosarcoma;
✓. Biomarker detection and tumor sample collection meet the following standards:
✓. Sufficient organ functions, which is defined as:
✓. Patients must have lesions that can be measured according to RECIST v1.1 standard;
Exclusion criteria
✕. The exclusion criteria of bevacizumab were clinically significant cardiovascular and cerebrovascular diseases, history of abdominal fistula or gastrointestinal perforation, acute intestinal obstruction or sub obstruction, and active bleeding;
✕. Uncontrolled hypertension (systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg) or clinically significant (active) cardiovascular disease: cerebrovascular accident (CVA) / stroke ≤ 6 months from the treatment of the first clinical study; Myocardial infarction ≤ 6 months from the first clinical study treatment; Unstable angina pectoris; Congestive heart failure (CHF) of grade II or above in the cardiac function classification standard of the New York Heart Association (NYHA); Serious arrhythmias requiring treatment;
✕. Previous medical history showed newly discovered thrombotic diseases within 6 months before or during the screening period; Patients with severe wound nonunion, ulcer, or fracture;
✕. Major surgery within 30 days before the first administration of study treatment; Patients expected to have invasive surgery during treatment;
✕. Patients with other malignant tumors;
✕. Patients who have previously received anti-programmed cell death protein-1 (anti-PD-1), anti-programmed death ligand-1 (anti-PD-L1) or anti-PD-L2 drugs, or another drug treatment for T cell inhibitory receptors (e.g., cytotoxic T lymphocyte-associated antigen-4 \[CTLA-4\], OX-40, CD137 \[tumor necrosis factor receptor superfamily member 9 (tnfrsf9)\];
✕. Active autoimmune diseases requiring systemic treatment in the past 2 years;
✕. Any case requiring systemic treatment with corticosteroids (prednisone or equivalent \> 10 mg/day) or other immunosuppressive drugs ≤ 14 days before the first administration of the study drug;