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A prospective, single arm, multicenter, phase II clinical trial of nab-paclitaxel combined with carboplatin in the first-line treatment of epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer

A prospective, single arm, multicenter, phase II clinical trial of nab-paclitaxel combined with carboplatin in the first-line treatment of epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039581
Enrollment
Unknown
Registered
2020-11-01
Start date
2020-11-01
Completion date
Unknown
Last updated
2021-02-08

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

Conditions

Ovarian cancer

Interventions

one arm:nab-paclitaxel in combination with carboplati

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age 18~70 years old; 2. Histologic diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma; 3. Stage IC to IV according to International Federation of Gynecology and Obstetrics staging system; 4. Imaging assessment according to RECIST1.1, measurable lesion,or evaluating CA-125 according to GCIG; 5. Neoadjuvant chemotherapy can be given before surgery to patients whose tumors are too large or whose lesions have a wide range and are not expected to achieve ideal tumor cell reduction; 6. Eastern Cooperative Oncology Group performance status = 3 months; 8.Left ventricular ejection fraction(LVEF)>= 50%; 9. Bone marrow function: Neutrophil >= 1.5 x 10^9/L, platelet >= 100 x 10^9/L, hemoglobin >= 90g/L; 10. Liver and renal function:serum creatinine <= 1.5 times the upper limit of normal value, AST and ALT <= 2.5 times the upper limit of normal value or 5 times the upper limit of normal value with liver metastasis, total bilirubin <= 1.5 times the upper limit of normal value or <= 2.5 times the upper limit of normal value with Gilbert's Syndrom; 11. Subjects of childbearing age must agree to use effective contraception during the study period, Serum or urine pregnancy tests must be negative in women of childbearing age, Non-lactation patients; 12. Sign informed Consent.

Exclusion criteria

Exclusion criteria: 1. Low grade malignant potential tumor of ovary; 2. Previous chemotherapy of abdomen or pelvis; 3. Planning chemotherapy of abdomen or pelvis; 4. Previous or current presence of heart disease with a New York Heart Association grade 2 or above; 5. Malignant neoplasia (not including non-melanoma skin cancer or in-situ carcinoma of the uterine cervix, provided they are being adequately treated); 6. Uncontrolled systemic infections require antiinfective treatment; 7. Known to be allergic, highly sensitive or intolerant to investigational drugs or their excipients; 8. Previous sensory or motor neuropathy >= 2 grade; 9. Patient's inability to access the center determined by investigator.

Design outcomes

Primary

MeasureTime frame
objective response rate;

Countries

China

Contacts

Public ContactJie Jiang
qljiangjie@sdu.edu.cn+86 18560082008

Outcome results

None listed

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