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 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT04211168
Brief Summary:
The investigators design a phase II clinical study to explore the efficacy and safety of toripalimab plus lenvatinib as a second-line treatment in patients with advanced biliary tract cancers and to analyze potential biomarkers of therapeutic response.
Detailed Description:
This phase II trial is a single-arm, non-randomized and single-center clinical study.
It is estimated that 44 patients who met the study criteria will be enrolled in 2 years and treated with toripalimab plus lenvatinib in PUMCH. The investigators will follow up and collect subjects' data each month to evaluate the efficacy and safety of treatment, including overall survival and time to progression, until disease progression or death. Interim analysis and final analysis will be conducted when collecting data from 20 and 44 subjects, respectively in this trial. Histopathology and multi-omics data analysis will be used to explore potential biomarkers of treatment response.
Study Type: Interventional.
Masking: Open Label.
Study:
NCT04211168
Study Brief:
Protocol Section:
NCT04211168