Skip to content

Efficacy and Safety of Short-term Nab-paclitaxel plus Carboplatin for the First-line Treatment of Advanced Ovarian Cancer

Efficacy and Safety of Short-term Nab-paclitaxel plus Carboplatin for the First-line Treatment of Advanced Ovarian Cancer: a Non-randomized, Controlled, Multicenter, Open-label, Phase II Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900028165
Enrollment
Unknown
Registered
2019-12-14
Start date
2019-12-26
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Advanced Ovarian Cancer

Interventions

Experiment group:Nab-paclitaxel plus Carboplatin
Control group:Solvent paclitaxel plus Carboplatin

Sponsors

Liaoning Cancer Hospital & Institute, Cancer Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Female, 18 to 75 years old; 2) Stage II-IV ovarian epithelial cancer, fallopian tube cancer, and primary peritoneal cancer confirmed by histopathology; 3) Receiving primary tumor cytoreductive surgery to achieve R0 or R1 within 6 weeks before enrollment; 4) Have not received chemotherapy before; 5) ECOG = 3 months; 7) Bone marrow function: white blood cells >= 3 x 10^9 / L, neutrophils >= 1.5 x10^9 / L, platelets >= 100 x 10^9 / L, hemoglobin >= 90g / L; 8) Liver and kidney function: total bilirubin (TBIL) <= 1.5 times the upper limit of normal value, alanine aminotransferase (ALT), aspartate aminotransferase (AST) are <= 2.5 times the upper limit of normal value; if due to liver metastasis, the above indicators <= 5 times the upper limit of normal value; serum creatinine (Cr) <= 1.5 times the upper limit of normal value; 9) Non-lactating women; 10) Sign written informed consent before trial.

Exclusion criteria

Exclusion criteria: 1) Have received other anti-tumor treatments (such as radiotherapy and immunotherapy) within 1 month before starting treatment; 2) With central nervous system disease or brain metastasis; 3) Occurred peripheral neuropathy of degree II or above; 4) Uncontrolled serious diseases will affect the ability to receive treatment : such as severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active digestibility ulcers 5) History of other malignant tumors within 5 years(except cured skin basal cancer and cervical cancer) ; 6) Alergic or intolerant to the study-related drug or its excipients; 7) Participating in other clinical trials at the same time; 8) The investigator judges the subjects who are not suitable to participate in this study. 9)Patients who are willing to undergo maintenance therapy on the premise that the investigator informs them that maintenance therapy is available after the study treatment.

Design outcomes

Primary

MeasureTime frame
progression-free survival;

Secondary

MeasureTime frame
overall survival;adverse events;

Countries

China

Contacts

Public ContactDanbo Wang

Liaoning Cancer Hospital & Institute, Cancer Hospital of China Medical University

wangdanbo@cancerhosp-ln-cmu.com+86 18940251157

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026