Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
NCT ID:
NCT03773302
Pre Assignment Details:
Subjects meeting inclusion/exclusion criteria were randomly assigned 2:1 to receive oral infigratinib 125 mg (N=29) or gemcitabine+cisplatin (N=19). Randomization was stratified by unresectable locally advanced vs metastatic disease, geographic region (North America, Western Europe, Asia Pacific, and rest of the world), prior neoadjuvant/adjuvant treatment (yes/no) and received up to 1 cycle of prior gemcitabine-based chemotherapy for unresectable locally advanced or metastatic disease (yes/no).
Recruitment Details:
Participants with a diagnosis of advanced/metastatic or inoperable cholangiocarcinoma (CCA) with FGFR2 fusion/rearrangement were recruited to this open-label, randomized, controlled global study across Western Europe, North America, and Asia, based on documented evidence of FGFR2 genetic alteration. The first participant was treated on 18 March 2020. The data cutoff for the analysis was 02 March 2023.
Study:
NCT03773302
Study Brief:
Results Section:
NCT03773302