ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer
ConditionBiliary Tract Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorCHA University
About this trial
This prospective, multicenter, observational study aims to evaluate the role of circulating tumor DNA (ctDNA) in advanced or metastatic biliary tract cancer (BTC) patients in Korea. Tissue-based genomic profiling is often limited due to the anatomical challenges of tumor biopsy and insufficient DNA quality. ctDNA analysis offers a minimally invasive alternative for identifying actionable genetic alterations, including Fibroblast Growth Factor Receptor 2 (FGFR2) fusions, Isocitrate Dehydrogenase 1 (IDH1) mutations, and Human Epidermal Growth Factor Receptor 2 (HER2) amplifications. The study will recruit 100 patients across 11 institutions and assess the concordance between ctDNA and tissue genomic profiling, as well as the clinical relevance of ctDNA in predicting treatment outcomes and prognosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed advanced or metastatic biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma)
Prior to initiation of first-line systemic therapy
Patients who previously received systemic therapy and are able to provide a blood sample prior to initiation of subsequent therapy
Age ≥ 19 years at the time of enrollment
Disqualifiers
Refusal to provide blood samples for ctDNA testing
Inability to provide written informed consent
Trial population
Korean patients with advanced or metastatic biliary tract cancer (intrahepatic, extrahepatic, or gallbladder carcinoma), enrolled for ctDNA-based genetic profiling prior to systemic therapy or before subsequent treatment initiation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood Sampling for ctDNA Analysis
Other interventionApproximately 20 mL of peripheral blood will be collected from patients with advanced biliary tract cancer. Samples will be obtained prior to systemic therapy initiation (in about two-thirds of patients) or prior to subsequent therapy (in about one-third of patients). Additional blood draws may be performed at progression in patients with FGFR2 fusion, IDH1 mutation, or HER2 amplification. Collected samples will be centrally analyzed for genomic alterations using ctDNA profiling.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Advanced Biliary Tract Cancer Patients1 intervention
Trial outcomes
Primary outcomes
1
Detection of Actionable Genomic Alterations by ctDNA Profiling
Frequency of targetable genetic alterations, especially FGFR2 fusion, detected in ctDNA from patients with advanced biliary tract cancer.
Time frame
Baseline (within 30 days prior to initiation of systemic therapy or prior to subsequent treatment)Secondary outcomes
1
Frequency of Specific Genomic Alterations by ctDNA Analysis
Assessment of the frequency of specific genetic alterations (e.g., FGFR2 fusion) identified by ctDNA in Korean patients with advanced biliary tract cancer.
Time frame
Up to 24 months2
Proportion of Patients Receiving Targeted Therapy Based on ctDNA Findings
Percentage of patients who received targeted therapies (including pemigatinib for FGFR2 fusion) according to ctDNA-based genomic profiling results.
Time frame
Up to 24 monthsOther outcomes
1
Association of ctDNA Variant Allele Frequency With Clinical Prognosis
Correlation of maximum variant allele frequency (max VAF) in ctDNA with survival outcomes in advanced biliary tract cancer patients.
Time frame
Up to 24 months2
Clinical Outcomes in Patients Treated With Targeted Therapy
Proportion of patients achieving complete response, partial response, or stable disease based on RECIST v1.1 criteria among those treated with pemigatinib or other targeted therapies.
Time frame
Up to 24 months3
Survival Outcomes in Patients Receiving Targeted Therapy
Progression-free survival (PFS) and overall survival (OS) of patients treated with pemigatinib or other targeted therapies according to ctDNA findings.
Time frame
Up to 24 months4
Resistance Mechanisms and Clonal Evolution Identified by Serial ctDNA Analysis
Exploration of acquired resistance mechanisms and clonal evolution through repeat ctDNA analysis in patients treated with FGFR2 inhibitors such as pemigatinib.
Time frame
At progression or up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
CHA University
Lead sponsor
Handok Inc.
Collaborator
Source ClinicalTrials.gov