NCT05737303RecruitingPhase 3
Nab-paclitaxel Versus Sb-taxanes As First-Line Treatment in Advanced Ovarian Cancer
Nab-paclitaxel Versus Solvent-based Taxanes As First-Line Treatment for Patients With Advanced Ovarian Cancer
Source: ClinicalTrials.gov · Last updated 11 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of this study is to compare the efficacy and safety of nab-paclitaxel with solvent-based taxanes as first-line treatment for patients with advanced primary epithelial ovarian cancer (EOC), primary peritoneal carcinoma or fallopian tube carcinoma.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 538 (estimated)
- First submitted
- 2 Jan 2023
- Start date
- 27 Nov 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Diseases
- Ovarian cancer
- NCT number
- NCT05737303
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 538
- From 27 Nov 2023 to the primary completion date, 31 Dec 2025
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other malignant tumors within the previous 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
- Patients who have previously received chemotherapy or radiotherapy for pelvic cavity;
- Arteriovenous thrombosis events occurring within 6 months before randomization, such as cardiovascular and cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction, myocardial infarction), deep vein thrombosis and pulmonary embolism;
Other illness
- Patients with low malignant potential ovarian tumors;
- Uncontrolled systemic infection requiring anti-infective treatment;
Lab values
- Severe cardiovascular disease: Grade Ⅱ or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥470 ms); According to NYHA(New York Heart Association) criteria, patients with grade Ⅲ to Ⅳ cardiac insufficiency or left ventricular ejection fraction (LVEF) \< 55% indicated by color Doppler ultrasonography;
- Patients who are allergic to the active ingredients or excipients of albumin paclitaxel and carboplatin for injection;
Other
- Patients with central nervous system metastasis or peripheral neuropathy \> grade 1;
- Patients with severe myelosuppression, severe liver dysfunction (Child's Class III), or renal dysfunction at the time of screening;
- Pregnant or lactating women;
- Those who were considered unsuitable for inclusion by the researchers.
Who the study is looking for
- Epithelial ovarian cancer/tubal cancer/peritoneal cancer was diagnosed by histopathology or hydroexfoliation cytopathology of the chest and abdomen, and was classified as stage III-IV according to FIGO(International Federation of Gynecology and Obstetrics)stage
- Physical condition Eastern Cooperative Oncology Group PS score: 0-2 points
- Participants who had not participated in other drug clinical trials within 4 weeks prior to enrollment
- Written informed consent
- Expected survival ≥6 months
- The disease met the criteria for Efficacy Evaluation of solid tumors (RECIST 1.1)
- Be able to comply with outpatient treatment, laboratory monitoring, and necessary clinical visits during study participation.
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Not yet recruiting |
| Sir Run Run Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Not yet recruiting |
| The first affiliated hospital of medical college of zhejiang university Coordinator of this site? Confirm its status | Hangzhou | China | Not yet recruiting |
| Yaxia Chen Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| the Second Affiliated Hospital of Medical College of Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Not yet recruiting |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Ji'nan | China | Not yet recruiting |
| Ningbo women's and children's Hospital Coordinator of this site? Confirm its status | Ningbo | China | Not yet recruiting |
| The No, 1 People's Hospital of Ningbo Coordinator of this site? Confirm its status | Ningbo | China | Not yet recruiting |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Not yet recruiting |
| The Second Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.