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

Sponsor
CHA University
Study ID
NCT06648057
Status
Recruiting
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Conditions

  • Biliary Tract Cancer
  • Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • lenvatinib plus pembrolizumab — DRUG
    * 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).

Study Details

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.

Key Dates

First listed
Oct 18, 2024
Start date
Sep 23, 2024
Status verified
Mar 2026
Primary completion
Sep 23, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Len/Pemb
    lenvatinib plus pembrolizumab combination therapy.

Primary Outcome Measure

collected tumor samples [ Time Frame: through study competition, an average of 2 years ]

Central Contacts

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