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Paclitaxel for Injection (Albumin-bound) in Combination with Carboplatin for First-Line Chemotherapy of Ovarian Cancer: a Multicenter, Open-Label, Single-Arm Clinical Study

Paclitaxel for Injection (Albumin-bound) in Combination with Carboplatin for First-Line Chemotherapy of Ovarian Cancer: a Multicenter, Open-Label, Single-Arm Clinical Study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034491
Enrollment
Unknown
Registered
2020-07-06
Start date
2020-07-10
Completion date
Unknown
Last updated
2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ovarian cancer

Interventions

Experimental group:Paclitaxel for injection (albumin bound) 260 mg/m2, d1, Carboplatin injection AUC 5~6, d1, 21 days in one cycle, 6 cycles in total.

Sponsors

Medical University Affiliated Tumor Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Female, aged 18 to 75 years; 2) Histological or cytological confirmation of Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer; 3) Newly diagnosed Stage III-IV disease according to International Federation of Gynecology and Obstetrics (FIGO) stage; 4) At least one measurable objective lesion (both primary and metastatic) was identified based on the RECIST1.1 criteria; 5) ECOG performance status 0-2; 6) Expected survival time more than 3 months; 7) Bone marrow function: Neutrophils >= 1.5 x10^9/L, platelets >= 100 x 10^9/L, hemoglobin >= 90 g/L; Serum creatinine <= 1.5x ULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)<= 2.5x ULN or when liver metastases occur<= 5x ULNTotal bilirubin <= 2.5 x ULN; 8) There was no second tumor within 5 years, except for cured Basal cell carcinoma or squamous cell carcinoma of skin or carcinoma; in situ at any other site. 9) Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with low malignant potential ovarian tumors; 2) Received systemic antitumor therapy for ovarian cancer (Patients with previous chemotherapy, monoclonal antibodies, tyrosine kinase inhibitors or hormones, abdominal or pelvic radiotherapy); 3) Have other malignant tumors within 5 years, except melanoma skin cancer or cervical cancer in situ; 4) These who were suffer from uncontrolled serious medical disease that researchers believe will affect the treatment of uncontrolled serious medical disease. For example, serious medical diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer and so on; 5) Known to be allergic, highly sensitive or intolerable to research-related drugs or excipients; 6) Receive chemotherapy within 30 days before the first chemotherapy; 7) Patients who were unsuitable for this study judged by investigators; 8) Female patients who are pregnant or lactating; those of childbearing age who refuse to accept contraception.

Design outcomes

Primary

MeasureTime frame
PFS;

Countries

China

Contacts

Public ContactLi Li

Medical University Affiliated Tumor Hospital

lili@gxmu.edu.cn+86 13878113406

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026