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

NCT06648057 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

lenvatinib 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).

Sponsors & Collaborators

  • CHA University

    lead OTHER

Principal Investigators

  • Hong Jae Chon, MD. PhD · CHA University

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-23
Primary Completion
2026-09-23
Completion
2026-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06648057 on ClinicalTrials.gov