Adjuvant Chemotherapy of Three-step Regimen in BRCA1/2 Wide Type Ovarian Cancer (ACTS-2)

Korábbi kezelés

• Receipt of any other investigational medicinal product within the last 30 days before randomization.
• Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, Ductal Carcinoma in Situ (DCIS), stage 1 grade 1 endometrial carcinoma, or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥ 5 years.
• Receipt of pelvic or abdominal radiotherapy

Más betegség

• Any uncontrolled medical condition that may put the patient at high risk during treatment .
• Severe heart/ lung/ liver/ kidney failure.
• uncontroled or active infection disease.

Egyéb

• Primary or secondary immune deficiency.
• Legal incompetence, limited legal competence, or detainment in an institution for official or legal reasons.
• Mucinous adenocarcinoma, low grade carcinoma

• 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)