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:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
NCT ID:
NCT05174650
Brief Summary:
The study trial is a open-label, single-arm, multicenter phase II trial investigating the combined treatment of atezolizumab and derazantinib in patients with advanced intrahepatic cholangiocarcinoma with FGFR2 fusions/rearrangements
Detailed Description:
The aim of this phase II study is to explore the safety and anti-tumor efficacy of the combination of atezolizumab and derazantinib in patients with advanced intrahepatic cholangiocarcinoma, with ORR as the primary endpoint.
The primary endpoint is the Objective Response Rate (ORR \[assessed every 8 weeks (±7 days)\]):
Objective response rate (ORR) according to investigator-based RECIST 1.1 assessment, defined as the proportion of allocated subjects with best response of complete or partial response within 9 months after the date of first administration of study treatment.
The secondary endpoints are safety and efficacy and will be evaluated by
* Incidence, treatment relationship, seriousness, and severity of all AEs, SAEs, AESIs according to CTCAE V5.0
* ORR@EOT:
Objective response rate (ORR) according to investigator-based RECIST 1.1 assessment, defined as the proportion of allocated subjects with best response of complete or partial response within study treatment.
• PFSR@6, 8 and 10 months: The proportion of patients known to be alive and without confirmed objective disease progression at 6, 8 and 10 months after first administration of study treatment, respectively.
• PFS: Time from first administration of study treatment until the date of first objective disease progression or death.
• OS: Time from first administration of study treatment until death of a patient due to any cause
Study:
NCT05174650
Study Brief:
Protocol Section:
NCT05174650