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:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT06548412
Brief Summary:
To evaluate combination therapy of adding CTX-009 to the standard therapy GCD as first-line therapy in patients with unresectable or mBTC.
Detailed Description:
Primary Objectives:
1. Assess tolerability/safety of this combination and determine the maximum tolerated dose (MTD) of CTX-009.
2. Assess 6 month progression-free survival to the combination therapy according to RECIST 1.1
Secondary Objectives:
1. Assess objective response rate (ORR)
2. Assess duration of response (DOR)
3. Assess overall survival (OS)
4. Assess progression free survival (PFS)
Study:
NCT06548412
Study Brief:
Protocol Section:
NCT06548412