Efficacy and Safety of Paclitaxel for Injection (Albumin-bound) for First-line Chemotherapy of Ovarian Cancer

Study Overview
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Brief Summary
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Preliminary evaluation of the efficacy and safety of paclitaxel for injection (albumin-bound) in combination with carboplatin for first-line chemotherapy of ovarian cancer.

Official Title
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Efficacy and Safety of Paclitaxel for Injection (Albumin-bound) in Combination With Carboplatin for First-line Chemotherapy of Ovarian Cancer: A Multicenter, Open-label, Single-arm Phase 2 Clinical Study

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: Paclitaxel for injection (albumin-bound)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 to 75 years; Histologically confirmed epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer; Patients with stage IC-IV according to the International Federation of Obstetrics and Gynecology (FIGO) and who underwent an ideal tumor reduction procedure within 6 weeks prior to enrollment; Lesion is measurable according to RECIST 1.1 criteria or patient's CA125 is evaluable according to GCIG criteria; ECOG performance status of 0-2; Expected survival ≥ 3 months; Bone marrow function: Neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90 g/L; Hepatic and renal function: Serum creatinine ≤ 1.5×ULN; AST and ALT ≤ 1.5×ULN or ≤ 5×ULN in the presence of hepatic metastasis; Total bilirubin ≤ 1.5×ULN, or ≤ 2.5×ULN in patients with Gilbert's syndrome; Must agree to use effective contraception during the trial; Women of childbearing potential must have a negative serum or urine pregnancy test; Non-lactating patients. Exclusion Criteria: Ovarian low-grade malignant tumor patients; Patients who have received abdominal or pelvic radiotherapy; Patients with central nervous system disease or brain metastases; Other malignancies have occurred within the last 5 years, except for cervical carcinoma in situ, non-melanoma skin cancers that have been cured; Prior Grade ≥ 2 sensory or motor neuropathy; Uncontrolled serious medical conditions that, in the opinion of the investigator, would affect the ability of the subject to receive the study regimen, such as concomitant serious medical conditions, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.; Known to be hypersensitive, highly sensitive, or intolerant to study-related medications or their excipients; Receive other study drug chemotherapy within 30 days of the first dose of chemotherapy; Patients not suitable for participation in this study judged by investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel for injection (albumin-bound)<br> | Drug: Paclitaxel for injection (albumin-bound)<br>* Paclitaxel for injection (albumin-bound) 260 mg/m2, i.v., d1; AUC = 5 for carboplatin injection, i.v., infusion completed on day 1-3; Repeated every 3-4 weeks for 6-8 cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free Survival | PFS | 2 year |