NCT04834544 A Study of Maintenance DCVAC/OvCa After First-line Chemotherapy Added Standard of Care
| NCT ID | NCT04834544 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peking University Third Hospital |
| Condition | Epithelial Ovarian Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2021-04-19 |
| Primary Completion | 2024-10-20 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a randomized, double-blind, placebo-controlled,parallel-group preliminary verifying study about safety and efficacy of maintenance DCVAC/OvCa after first-line chemotherapy added to standard of care in patients with newly diagnosed FIGO III-IV ovarian, fallopian tube, or primary peritoneal carcinoma.
Eligibility Criteria
Inclusion Criteria: 1. Eighteen years of age or older at the time written informed consent is obtained 2. Newly diagnosed, histologically confirmed FIGO stage III or IV EOC (high-grade serous or high-grade endometrioid) 3. After primary debulking surgery or after interval debulking surgery; residual disease after surgery with optimal resection as R0 or R1 (R0 is defined as no macroscopic residual disease, R1 is defined as macroscopic residual disease with a maximal diameter of \<1 cm) 4. Known BRCA status; if BRCA mutation status not known, results of BRCA testing must be available before randomization 5. Laboratory criteria: 5.1. White blood cells \>4000/mm3 (4.0×109/L) 5.2. Neutrophil count \>1500/mm3 (1.5×109/L) 5.3. Hemoglobin ≥8 g/dL (80 g/L) 5.4. Platelet count ≥100,000/mm3 (100×109/L) 5.5. Total bilirubin \<2× upper limit of normal (ULN) (benign hereditary hyperbilirubinemias, e.g., Gilbert's syndrome, are permitted) 5.6. Serum alanine aminotransferase, aspartate aminotransferas