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

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

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 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.
* Severe heart/ lung/ liver/ kidney failure.
* uncontroled or active infection disease.
* Legal incompetence, limited legal competence, or detainment in an institution for official or legal reasons.
* Receipt of pelvic or abdominal radiotherapy
* Mucinous adenocarcinoma, low grade carcinoma

Conditions2

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