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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT03903705
Brief Summary:
This is a phase Ib/II study to evaluate the safety, tolerability, PK profile and preliminary efficacy of fruquintinib monotherapy or plus sintilimab for advanced solid tumors. This study includes fruquintinib plus sintilimab treatment arm (dose escalation phase and dose expansion phase), and fruquintinib monotherapy arm.
Detailed Description:
This study is composed of Fruquintinib plus sintilimab treatment arm and Fruquintinib monotherapy arm.
Fruquintinib plus sintilimab treatment arm:
* Dose escalation phase: it is planned to enroll about 26-39 patients
* Dose expansion phase: it is planned to enroll about 309-329 patients, including about 140 patients with endometrial cancer
Fruquintinib monotherapy arm: about 13 patients with advanced endometrial cancer
Study:
NCT03903705
Study Brief:
Protocol Section:
NCT03903705