RecruitingNCT06648057

Investigation of Predictive Biomarkers in Patients With Advanced BTC Treated With Lenvatinib Plus Pembrolizumab

Investigation of Predictive Biomarkers in Patients With Advanced Biliary Tract Cancer Treated With Lenvatinib Plus Pembrolizumab

Sponsor

CHA University

Enrollment

100 participants

Start Date

Sep 23, 2024

Study Type

OBSERVATIONAL

Conditions

Biliary Tract Cancer Cholangiocarcinoma

Summary

The goal of this observational study is to evaluate the clinical efficacy and safety of lenvatinib plus pembrolizumab combination therapy in patients with advanced biliary tract cancer (BTC). This study aims to identify potential biomarkers that may predict treatment response by analyzing genetic data from blood and tissue samples. The study will focus on real-world clinical outcomes and the exploratory discovery of biomarkers associated with the efficacy of this treatment regimen.

Eligibility

Min Age: 20 Years

Inclusion Criteria5

Patients with histologically or cytologically confirmed advanced biliary tract cancer.
Patients scheduled to receive Lenvatinib + Pembrolizumab for the treatment of advanced biliary tract cancer.
ECOG performance status of 0-2.
Patients aged 20 years or older at the time of treatment initiation.
Patients who understand and consent to participate in this study, and agree to provide samples obtained during the examination process.

Exclusion Criteria1

Patients who do not consent to participate in the study or withdraw their consent.

Interventions

DRUGlenvatinib plus pembrolizumab

* The collection of peripheral blood samples will follow the schedule below (20 cc per collection, up to 5 times): * Before systemic therapy, at 3 weeks after starting systemic therapy (Cycle 1), at 6 weeks (Cycle 2) * (If possible) at the time of confirmed partial response (1 time), and at the time of disease progression (1 time). * Additional tumor tissue samples will be collected only if possible, according to the following schedule: If the patient undergoes surgery or additional biopsy related to treatment (collected from preserved specimens).