Nab-paclitaxel Versus Sb-taxanes As First-Line Treatment in Advanced Ovarian Cancer

Last updated: February 9, 2025
Sponsor: Women's Hospital School Of Medicine Zhejiang University
Overall Status: Active - Recruiting

Phase

3

Condition

Fallopian Tube Cancer

Ovarian Cysts

Carcinoma

Treatment

nab-paclitaxel combined with carboplatin

Clinical Study ID

NCT05737303
IRB-20230058-R
  • Ages 18-75
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Epithelial ovarian cancer/tubal cancer/peritoneal cancer was diagnosed byhistopathology or hydroexfoliation cytopathology of the chest and abdomen, and wasclassified as stage III-IV according to FIGO(International Federation of Gynecologyand 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 weeksprior 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 necessaryclinical visits during study participation.

Exclusion

Exclusion Criteria:

  1. Patients with low malignant potential ovarian tumors;

  2. Other malignant tumors within the previous 5 years, except for cured cervicalcarcinoma in situ and non-melanoma skin cancer;

  3. Patients who have previously received chemotherapy or radiotherapy for pelviccavity;

  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 myocardialinfarction, poorly controlled arrhythmias (including QTc interval ≥470 ms);According to NYHA(New York Heart Association) criteria, patients with grade Ⅲ to Ⅳcardiac insufficiency or left ventricular ejection fraction (LVEF) < 55% indicatedby color Doppler ultrasonography;

  7. Uncontrolled systemic infection requiring anti-infective treatment;

  8. Arteriovenous thrombosis events occurring within 6 months before randomization, suchas cardiovascular and cerebrovascular accidents (including temporary ischemicattack, cerebral hemorrhage, cerebral infarction, myocardial infarction), deep veinthrombosis and pulmonary embolism;

  9. Patients who are allergic to the active ingredients or excipients of albuminpaclitaxel and carboplatin for injection;

  10. Pregnant or lactating women;

  11. Those who were considered unsuitable for inclusion by the researchers.

Study Design

Total Participants: 538
Treatment Group(s): 1
Primary Treatment: nab-paclitaxel combined with carboplatin
Phase: 3
Study Start date:
November 27, 2023
Estimated Completion Date:
December 31, 2027

Study Description

One of the major challenges related to solvent-based taxanes administration in clinical practice is the high rate of hypersensitivity reactions (HSRs). Nab-paclitaxel has showed its considerable survival and low toxicity profiles in first-line treatment for several solid tumors and is recommended as a treatment for recurrent epithelial ovarian cancer (EOC). We focus on clinical efficacy and safety outcomes of nab-paclitaxel in current clinical studies of primary EOC treatment and aim to explore the potential feasibility of nab-paclitaxel as the first-line treatment for EOC, primary peritoneal carcinoma or fallopian tube carcinoma.

Connect with a study center

  • Sun Yat-Sen University Cancer Hospital

    Guangzhou, Guangdong
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Ji'nan, Shandong 250012
    China

    Site Not Available

  • Sir Run Run Hospital

    Hangzhou, Zhejiang
    China

    Site Not Available

  • The First Affiliated Hospital of Medical College of Zhejiang University

    Hangzhou, Zhejiang
    China

    Site Not Available

  • The Second Affiliated Hospital of Medical College of Zhejiang University

    Hangzhou, Zhejiang
    China

    Site Not Available

  • Yaxia Chen

    Hangzhou, Zhejiang 310006
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang
    China

    Site Not Available

  • Ningbo women's and children's Hospital

    Ningbo, Zhejiang
    China

    Site Not Available

  • The No, 1 People's Hospital of Ningbo

    Ningbo, Zhejiang
    China

    Site Not Available

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou,
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.