Comparing nab-paclitaxel and solvent-based taxanes for advanced ovarian cancer treatment
Nab-paclitaxel Versus Solvent-based Taxanes As First-Line Treatment for Patients With Advanced Ovarian Cancer
This study is testing if a new treatment called nab-paclitaxel, combined with carboplatin, is safer and more effective than standard treatments for people with advanced ovarian cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 538 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 11 sites (Guangzhou, Guangdong and 10 other locations) |
| Trial ID | NCT05737303 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness and safety of nab-paclitaxel compared to solvent-based taxanes as the first-line treatment for patients with advanced epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube carcinoma. The research focuses on addressing the high rate of hypersensitivity reactions associated with solvent-based taxanes by investigating the potential of nab-paclitaxel, which has shown promising survival rates and lower toxicity in previous treatments. Participants will receive nab-paclitaxel in combination with carboplatin, and the study will assess clinical efficacy and safety outcomes based on established criteria.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with stage III-IV epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma who meet specific health criteria.
Not a fit: Patients with low malignant potential ovarian tumors or those who have previously received chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective first-line treatment option for patients with advanced ovarian cancer.
How similar studies have performed: Previous studies have shown promising results for nab-paclitaxel in treating recurrent ovarian cancer, indicating potential for success in this first-line treatment approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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 2. Physical condition Eastern Cooperative Oncology Group PS score: 0-2 points 3. Participants who had not participated in other drug clinical trials within 4 weeks prior to enrollment 4. Written informed consent 5. Expected survival ≥6 months 6. The disease met the criteria for Efficacy Evaluation of solid tumors (RECIST 1.1) 7. Be able to comply with outpatient treatment, laboratory monitoring, and necessary clinical visits during study participation. Exclusion Criteria: 1. Patients with low malignant potential ovarian tumors; 2. Other malignant tumors within the previous 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer; 3. Patients who have previously received chemotherapy or radiotherapy for pelvic cavity; 4. Patients with central nervous system metastasis or peripheral neuropathy \> grade 1; 5. Patients with severe myelosuppression, severe liver dysfunction (Child's Class III), or renal dysfunction at the time of screening; 6. 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; 7. Uncontrolled systemic infection requiring anti-infective treatment; 8. 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; 9. Patients who are allergic to the active ingredients or excipients of albumin paclitaxel and carboplatin for injection; 10. Pregnant or lactating women; 11. Those who were considered unsuitable for inclusion by the researchers.
Where this trial is running
Guangzhou, Guangdong and 10 other locations
- Sun Yat-Sen University Cancer Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
- Qilu Hospital of Shandong University — Ji'nan, Shandong, China (Not_yet_recruiting)
- Yaxia Chen — Hangzhou, Zhejiang, China (Recruiting)
- Sir Run Run Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)
- The First Affiliated Hospital of Medical College of Zhejiang University — Hangzhou, Zhejiang, China (Not_yet_recruiting)
- The Second Affiliated Hospital of Medical College of Zhejiang University — Hangzhou, Zhejiang, China (Not_yet_recruiting)
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)
- Ningbo women's and children's Hospital — Ningbo, Zhejiang, China (Not_yet_recruiting)
- The No, 1 People's Hospital of Ningbo — Ningbo, Zhejiang, China (Not_yet_recruiting)
- The Second Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Not_yet_recruiting)
- The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, China (Not_yet_recruiting)
Study contacts
- Principal investigator: Yaxia Chen, MD — Study Principal Investigator
- Study coordinator: Yaxia Chen, MD
- Email: chenyax@zju.edu.cn
- Phone: +86-571-87061501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.