Evaluating biomarkers in advanced biliary tract cancer treatment with lenvatinib and pembrolizumab
Investigation of Predictive Biomarkers in Patients With Advanced Biliary Tract Cancer Treated With Lenvatinib Plus Pembrolizumab
This study is testing if a combination of two drugs, lenvatinib and pembrolizumab, can help people with advanced biliary tract cancer and is looking for clues in their genetic data to see how well the treatment works.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | CHA University Academic / other |
| Drugs / interventions | Pembrolizumab, Lenvatinib, durvalumab |
| Locations | 1 site (Seongnam-si, Gyeonggi-do) |
| Trial ID | NCT06648057 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the clinical efficacy and safety of a combination therapy using lenvatinib and pembrolizumab in patients with advanced biliary tract cancer (BTC). The research focuses on identifying potential predictive biomarkers by analyzing genetic data from blood and tissue samples. By examining real-world clinical outcomes, the study seeks to enhance understanding of treatment responses and improve future therapeutic strategies for BTC patients.
Who should consider this trial
Good fit: Ideal candidates include patients aged 20 years or older with confirmed advanced biliary tract cancer who are scheduled to receive lenvatinib and pembrolizumab.
Not a fit: Patients who do not consent to participate or withdraw their consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment options for patients with advanced biliary tract cancer.
How similar studies have performed: Previous studies have shown promising results with similar combination therapies in advanced biliary tract cancer, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Patients who do not consent to participate in the study or withdraw their consent.
Where this trial is running
Seongnam-si, Gyeonggi-do
- Bundang CHA Medical Center — Seongnam-si, Gyeonggi-do, South Korea (Recruiting)
Study contacts
- Principal investigator: Hong Jae Chon, MD. PhD — CHA University
- Study coordinator: Hong Jae Chon, MD. PhD
- Email: minidoctor@cha.ac.kr
- Phone: 82-31-780-3928
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.