A Study of Maintenance DCVAC/OvCa After First-line Chemotherapy Added Standard of Care
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.
| Condition(s) | Epithelial Ovarian Carcinoma, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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/ |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Peking University Third Hospital |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2021-04-19 |
| NCT ID | NCT04834544 |
| Official listing | https://clinicaltrials.gov/study/NCT04834544 |