Spots Global Cancer Trial Database for Toripalimab Plus Lenvatinib as Second-line Treatment in Advanced Biliary Tract Cancers

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Toripalimab Plus Lenvatinib as Second-line Treatment in Advanced Biliary Tract Cancers

Official Title: Toripalimab Plus Lenvatinib as Second-line Treatment in Advanced Biliary Tract Cancers: a Single-arm, Non-randomized, Single-center Clinical Trial and Biomarker Study

Study ID: NCT04211168

Conditions

Advanced Biliary Tract Cancer

Interventions

Toripalimab plus Lenvatinib

Study Description

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.