Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT06552858
Brief Summary:
This study aims to investigate the safety and efficacy of combination therapy of Fluzoparib combined With Dalpiciclib for platinum-resistant recurrent ovarian cancer through a single-center, prospective, single-arm, phase II clinical trial, to improve the overall treatment level and prognosis of platinum-resistant ovarian cancer.
Detailed Description:
1. Overall Design: This trial is a single-center, prospective, single-arm, phase II clinical trial to evaluate the safety and efficacy of combination therapy of Fluzoparib combined With Dalpiciclib for platinum-resistant recurrent ovarian cancer.
2. Experimental observation indicators: 1) Main indicators: progression-free survival (PFS), 2) Other indicators: overall survival (OS), objective response rate (ORR), and adverse reactions.
3. Sample size calculation: The median PFS of platinum-resistant recurrent ovarian cancer patients is 3.8 months. In comparison, the experimental group is expected to have a median PFS of 7 months, with an alpha value of 0.05. Following up for 1 year and considering a 10% dropout rate, this study plans to include 30 platinum-resistant recurrent ovarian cancer patients.
4. Data Processing: Enter data and use SPSS statistical software for statistical analysis. Statistical analyst: Clinical Statistics Department of Fudan University Cancer Hospital. Mailing address: 270 Dong'an Road, Shanghai.
Study:
NCT06552858
Study Brief:
Protocol Section:
NCT06552858