Skip to content

Paclitaxel for injection (albumin-bound) combined with carboplatin in the treatment of epithelial ovarian cancer: a single-arm, open, multicenter clinical study.

Paclitaxel for injection (albumin-bound) combined with carboplatin in the treatment of epithelial ovarian cancer: a aingle-arm, open, multicenter clinical study.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024400
Enrollment
Unknown
Registered
2019-07-10
Start date
2019-08-01
Completion date
Unknown
Last updated
2020-07-20

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 binding) 260mg/m2, d1, Carboplatin injection AUC 5, d1, 21 days in one cycle, 6 cycles in total.

Sponsors

Fourth Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Female, aged 18 to 70 years; 2) Histological or cytological confirmation of epithelial ovarian cancer, carcinoma tubae, or primary peritoneal carcinoma; 3) Stage IC-IV disease according to International Federation of Gynecology and Obstetrics (FIGO) stage; 4) ECOG performance status 0-2; 5) Expected survival time more than 3 months; 6) Bone marrow function: Neutrophils >= 1.5×10^9/L, platelets >= 100×10^9/L, hemoglobin >= 90 g/L; 7) Liver and renal functionSerum creatinine <= 1.5x ULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)<= 2.5x ULN or when liver metastases occur<= 5x ULN, Total bilirubin <= 1.5x ULN; 8) Subjects of child-bearing age must agree to take effective contraceptive measures during the study periodPregnancy tests in serum or urine must be negative for Female of child-bearing ageNon-lactating patients; 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)In the past 5 years, there were other malignant tumors, melanoma skin cancer or ervical carcinoma in situ were excepted; 4)These who were suffer from uncontrolled serious medical disease that researchers believe will affect the treatment of uncontrolled serious medical diseaseFor 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)Chemotherapy with other research drugs within 30 days of first chemotherapy; 7)Researchers judged patients who were unsuitable for this study.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
OS;Quality of life score;Security;

Countries

China

Contacts

Public ContactShan Kang

Fourth Hospital of Hebei Medical University

395928206@qq.com+86 13832325100

Outcome results

None listed

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