Trials / Active Not Recruiting
Active Not RecruitingNCT04807166
Anlotinib Combined With Carboplatin/Paclitaxel as First-line Treatment in Patients With Advanced Ovarian Cancer
A Prospective, Single-arm, Multicenter, Exploratory Phase II Study to Evaluate the Efficacy and Safety of Anlotinib Combined With Carboplatin/Paclitaxel as First-line Treatment in Patients With Advanced Ovarian Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Wenjun Cheng · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
It has been reported that antiangiogenic drugs combined with chemotherapy as first-line treatment, and subsequent antiangiogenic drugs as maintenance therapy for ovarian cancer can achieve better clinical benefits. Therefore, this study is expected to investigate the efficacy and safety of anlotinib combined with carboplatin/paclitaxel as first-line treatment in patients with advanced ovarian cancer.
Detailed description
This study is a single-arm, multicenter, exploratory phase II study to observe the efficacy and safety of anlotinib combined with carboplatin/paclitaxel as first-line treatment in patients with advanced ovarian cancer. The primary end point are progression free survival; the secondary end points include objective response rate, disease control rate, overall survival and safety. The subjects in this study: patients with newly diagnosed advanced (FIGO stage III-IV) ovarian cancer, including histologically or pathologically confirmed high-grade serous ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma
Conditions
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Female
- Neoplasms, Glandular and Epithelial
- Neoplasms by Histologic Type
- Carcinoma, Ovarian Epithelial
- Ovarian Diseases
- Genital Diseases, Female
- Endocrine System Diseases
- Carcinoma
- Anlotinib
- Angiogenesis
- Antineoplastic Agents
- Tyrosine Kinase Inhibitor
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Drug: Anlotinib | Anlotinib will be administered orally,once a day (12 mg) on days 1-14 of a 21-day cycle |
| DRUG | Drug: Carboplatin/Paclitaxel | Paclitaxel 175 mg/m2 was given intravenously for 3 hours, D1 Carboplatin AUC 5 was given intravenously for 1 hour, D1 |
Timeline
- Start date
- 2021-08-24
- Primary completion
- 2025-09-30
- Completion
- 2027-12-31
- First posted
- 2021-03-19
- Last updated
- 2024-07-03
Locations
6 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04807166. Inclusion in this directory is not an endorsement.