Comparing nab-paclitaxel and solvent-based taxanes for advanced ovarian cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Yaxia Chen
  Hangzhou, Zhejiang, China Recruiting
• Sun Yat-Sen University Cancer Hospital
  Guangzhou, Guangdong, China Not yet recruiting
• Qilu Hospital of Shandong University
  Ji'nan, Shandong, China Not yet 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

Study contacts

• Principal investigator: Yaxia Chen, MD — Study Principal Investigator
• Study coordinator: Yaxia Chen, MD
• Email: chenyax@zju.edu.cn
• Phone: +86-571-87061501

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.