evaluation of pld combined with carboplatin versus paclitaxel plus carboplatin in the first-line treatment of epithelial ovarian cancer

Conditions: Efficacy and Safety

Summary: this is a randomized, multicenter, open, controlled post-marketing study. 396 patients who were histopathology or exfoliated cell pathology of pleural and ascites confirmed with epithelial ovarian cancer/fallopian tube/peritoneal cancer were enrolled in this study. the subjects will be randomly assigned to one of the two treatment groups at a 1: 1 ratio, and the stratification factors included: chemotherapy type (adjuvant chemotherapy/neoadjuvant chemotherapy), residual disease after surgery (\>1cm, \<1cm, no primary surgery), stage (ic, ii, iii or iv), pathological typing, eastern cooperative oncology group performance status (0 to 1 or 2), brca1/2 gene mutation.

subjects will receive one of two treatment regimens: group a: intravenous infusion of liposomal doxorubicin 30 mg/m2, d1; carboplatin auc 5 (dosed according to the calvert formula, with creatinine clearance estimated according to the cockcroftformula), intravenous infusion, d1; once every 21days, 3\~6 cycles for early stage patients and 6 cycles for late stage. group b: intravenous infusion of paclitaxel 175 mg/m2, d1; carboplatin auc 5, intravenous infusion, d1; once every 21days, 3\~6 cycles for early stage patients and 6 cycles for late stage. treatment was initially administered for three cycles, and patients with stable or responding disease continued treatment for further a three cycles. the main purpose is to evaluate the efficacy and safety of liposomal doxorubicin plus carboplatin in the first-line treatment of epithelial ovarian cancer. the primary endpoint is progression free survival (pfs), the secondary endpoints include overall survival (os), objective response rate (orr), disease control rate (dcr):cr+pr+sd, the incidence and severity of adverse reactions and health-related quality of life (hql) assessment.

Eligibility criteria:
inclusion criteria: * 18-75years old; * histopathologically or exfoliated cell pathology of pleural and ascites confirmed with epithelial ovarian cancer/fallopian tube/peritoneal cancer; * according to the international federation of obstetrics and gynecology (figo), the stage is ic-iv; * imaging assessment is based on the solid tumor efficacy evaluation standard (recist) version 1.1, lesions can be measured, or patients' ca125 assessed according to gcig criteria; * neoadjuvant chemotherapy can be given to patients with excessive tumor volume or a wide range of lesions, who are not expected to achieve ideal cytoreductions before surgery; * ecog score ≤ 2; * expected survival time ≥ 3 months; * lvef ≥ 50%; * bone marrow function: anc：≥1.5×109/l； plt：≥100×109/l；hb: ≥90g/l; * liver and renal function:serum creatinine ≤ normal upper limit (uln) 1.5times; aspartate aminotransferase (ast) and alanine aminotransferase (alt)≤uln 2.5times, or \<uln 5times in the presence of liver metastasis; total bilirubin (tbil) level≤ uln 1.5 times, or ≤ uln 2.5times if gilbert's syndrome are present; * the childbearing age subjects must agree to take effective contraceptive measures during the trial; the serum or urine pregnancy test must be negative, non-lactating; * signed the informed consent. exclusion criteria: * patients with low-grade malignant potential ovarian tumors; * patients who had previously received chemotherapy or pelvic and abdominal radiotherapy; * patients planning to receive abdominal or pelvic chemotherapy; * the new york heart association (nyha) graded class ii heart disease patients (including grade ii) previous or current; * other malignant tumors have been found in the past 5 years,except for cured cervical carcinoma in situ, non melanoma of the skin; * uncontrolled systemic infection requiring anti-infective treatment; * allergies to chemotherapeutic drugs or their excipients or intolerant patients; * subjects with ≥2 grade peripheral neuropathy according to ctcae v 4.03; * researchers think it is not suitable for enrolling.

Keywords: pegylated doxorubicin hydrochloride liposome injection duomeisu first-line treatment epithelial ovarian cancer