Adjuvant Chemotherapy of Three-step Regimen in BRCA1/2 Wide Type Ovarian Cancer (ACTS-2)
Trial Parameters
Brief Summary
Ovarian cancer was mostly diagnosed at late stage (III/IV) with high rate of recurrence after first line of therapy by optimal cytoreductive sugery and 6cycle of TP chemotherapy. There is no standard maintainance therapy for BRCA1/2 wide-type ovarian cancer. We developed an adjuvant chemotherapy of "three steps" (ACTS). It is adding CTX+VP-16(second step) 6cycle and CTX+CBP(third steps) to firstline chemotherapy (first step). The aim of this study is to verify the effectivity and safety of ACTS in BRCA1/2 wide-type ovarian cancer patients.
Eligibility Criteria
Inclusion Criteria: * Female patients 18-75 years of age. * ECOG 0-2 * Histologically-confirmed epithelial ovarian or fallopian-tube cancer or primary peritoneal cancer * FIGO2018 stage III/IV, * Patients should have received optimal cytoreductive surgery with residual tumor ≤ 1cm and no more than 9 cycle paclitaxel + platinum chemotherapy achieved complete remission (accessed ) and normal CA125. * No more than 8 months after the last chemotherapy. * Adequate bone marrow and hepatic function at Screening: * Hemoglobin ≥9 g/dL * White blood cell count ≥3.0 × 109/L * Absolute neutrophil count ≥1.5 × 109/L * Platelet count ≥100 × 109/L * AST (SGOT)/ALT (SGPT) ≤2.5 ULN * Bilirubin \<1.5 × ULN * Creatinine \<1.5 × ULN. * Ability and willingness to give written informed consent. * Tumor BRCA1/2 wilde type (qualified center test) Exclusion Criteria: * Primary or secondary immune deficiency. * Any uncontrolled medical condition that may put the patient at high risk during treatment . * Receipt