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A phase II study for Albumin-bound paclitaxel in combination with Nedaplatin in the treatment of patients with Platinum-resistant recurrent epithelial ovarian carcinoma

A phase II study for Albumin-bound paclitaxel in combination with Nedaplatin in the treatment of patients with Platinum-resistant recurrent epithelial ovarian carcinoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030875
Enrollment
Unknown
Registered
2020-03-16
Start date
2019-10-01
Completion date
Unknown
Last updated
2020-03-16

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

Conditions

ovarian cancer

Interventions

Case series:Albumin-bound paclitaxel?Nedaplatin

Sponsors

cancer Hospital Chinese Academy of Medical Science
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Patients with advanced ovarian epithelial cancer/fallopian tube cancer/primary peritoneal cancer who have relapsed with cisplatin/carboplatin resistance have not used albumin paclitaxel and/or nedaplatin in previous chemotherapy and are not primary platinum resistant; 2. Aged 18-70 years old; ECOG physical score 0-2 points; 3. Pathologically confirmed as epithelial cancer, and FIGO stage II-IV; 4. According to the RECIST 1.1 standard, it has clinically assessable lesions with a maximum diameter of metastatic lesions >=1 cm and lymph node metastasis of >=1.5 cm; and the target lesion is not suitable for surgical treatment; 5. Expected survival time is more than 4 months; 6. The main organ functions are normal, including but not limited to normal bone marrow function, liver and kidney function in accordance with chemotherapy indicators: (1) White blood cell count >=4 *10^9/L; (2) Neutrophil count >=2.0*10^9/L; (3) hemoglobin count >=90 g/L; (4) Platelet count >=100 *10^9/L; (5) ALT / AST=60 ml / min; 7. No long-term history of allergies, no allergy to the ingredients and ingredients of albumin-bound paclitaxel and nedaplatin; 8. No metastatic lesions in the brain; 9. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with primary platinum resistance, that is, patients with disease progression during the first use of platinum-containing chemotherapy; 2. Metastatic lesions in the central nervous system; 3. People who are in active infection and are not easy to control; 4. Patients with severe cardiopulmonary dysfunction and poor general condition, who cannot tolerate chemotherapy; 5. Those who cannot control pericardial effusion; 6. Patients with other tumors or previous history of other malignant tumors; 7. People who are receiving immunotherapy or endocrine therapy; 8. Pregnant and lactating women and those who are likely to become pregnant but do not wish to use appropriate contraceptive measures; 9. People with difficult-to-control mental illness; 10. Patients with allergic constitution; 11. Other circumstances that the investigator determined could not be included in the study.

Design outcomes

Primary

MeasureTime frame
objective response rate;

Secondary

MeasureTime frame
progress free survival;disease control rate;Overall survival;security;

Countries

China

Contacts

Public ContactYuanguang Meng

Cancer Hospital Chinese Academy of Medical Sciences

william327@163.com+86 13693684116

Outcome results

None listed

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