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Biliary Tract CancerNCT07151118

ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer

An observational study of Biliary Tract Cancer, run by CHA University at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Biliary Tract Cancer
What is being tested?
Blood Sampling for ctDNA Analysis
How many people
100 participants
Where
1 siteSouth Korea
Study dates
1 Sep 2025to 31 Aug 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study 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.

Who may be able to join

  • Histologically confirmed advanced or metastatic biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma)
  • Patients meeting one of the following conditions:
  • 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
  • Willingness and ability to provide blood samples for ctDNA analysis

Who cannot join

  • Refusal to provide blood samples for ctDNA testing
  • Inability to provide written informed consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hong Jae Chon, MD. PhD contact

82-31-780-3928

minidoctor@cha.ac.kr

Hong Jae Chon, MD. PhD contact

82-31-780-3928

hongjaechon@gmail.com

South Korea1 site, 1 recruiting

  • CHA Bundang Medical Center

    Seongnam-si, Gyeonggi-do, 13496

    Hong Jae Chon, MD. PhD, 82-31-780-3430, minidoctor@cha.ac.kr

    Hong Jae Chon

    Recruiting

Other trials in South Korea

About this study

Official title: Role of Circulating Tumor DNA (ctDNA) in Genetic Profiling and Clinical Outcomes for Advanced Biliary Tract Cancer (BTC) Patients - Prospective, Observational, Epidemiology Study

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.

Read the detailed description

Biliary tract cancer (BTC) is a heterogeneous and aggressive malignancy with poor prognosis, especially in advanced or metastatic stages where surgical resection is not feasible. The current standard first-line therapy with gemcitabine and cisplatin provides limited survival benefit, with median overall survival around 11-12 months. Targeted therapies, such as FGFR inhibitors for FGFR2 fusions and IDH1 inhibitors, as well as immune checkpoint inhibitors, have improved outcomes in subsets of patients. However, tumor tissue acquisition remains challenging in BTC, limiting the ability to perform comprehensive genomic profiling.

Circulating tumor DNA (ctDNA) has emerged as a promising biomarker for molecular profiling, treatment monitoring, and prognosis assessment. Prior studies demonstrated acceptable concordance between ctDNA-based and tissue-based next-generation sequencing, particularly for FGFR2 fusions, and highlighted the potential of ctDNA in identifying additional genomic alterations not detected in tissue samples.

This prospective study will enroll 100 Korean patients with advanced or metastatic BTC from 11 hospitals. Approximately two-thirds of patients will provide blood samples prior to first-line systemic therapy, while one-third will provide samples before subsequent therapy. Additional blood draws will be performed at progression in patients harboring FGFR2 fusion, IDH1 mutation, or HER2 amplification. Collected samples will be analyzed by a central laboratory (SCL Healthcare, a precision medicine service provider specializing in biomarker-based diagnostics).

The primary objective is to evaluate the frequency of actionable genomic alterations, especially FGFR2 fusions, detected by ctDNA in advanced BTC patients. Secondary objectives include:

  • Assessing the concordance between ctDNA and tissue genomic profiling
  • Evaluating the proportion of patients who received targeted therapy based on ctDNA results (e.g., pemigatinib [Pemazyre®])
  • Exploring associations between ctDNA maximum variant allele frequency (max VAF) and survival outcomes
  • Identifying potential resistance mechanisms and clonal evolution during targeted therapy

This study is expected to provide robust evidence for the clinical utility of ctDNA in BTC and contribute to the establishment of precision medicine approaches, potentially supporting future guideline development and regulatory approval of ctDNA assays in Korea and globally.

Being tested
Blood Sampling for ctDNA Analysis
Keywords
Biliary Tract Cancer, Biomarker, IDH1 mutation, FGFR2 fusion, Circulating Tumor DNA (ctDNA), Biomarker Analysis
Medical subject headings
Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood Sampling for ctDNA AnalysisOther

    Also called Liquid Biopsy; Plasma Collection

    Approximately 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.

Study groups in NCT07151118
Study groupRoleWhat they receive
Advanced Biliary Tract Cancer PatientsPatients with histologically confirmed advanced or metastatic biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer). Participants will provide blood samples for circulating tumor DNA (ctDNA) analysis before systemic therapy or prior to subsequent treatment.
Receives: Other: Blood Sampling for ctDNA Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (within 30 days prior to initiation of systemic therapy or prior to subsequent treatment)

Secondary outcomes (2)

  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.

    Measured: Up to 24 months

  2. 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.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2025
  2. Study start1 Sep 2025
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07151118
Sponsor's protocol ID
CHAMC2025-03-041
Status last verified
Mar 2026
First submitted
20 Aug 2025
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Baria K, De Toni EN, Yu B, Jiang Z, Kabadi SM, Malvezzi M. Worldwide Incidence and Mortality of Biliary Tract Cancer. Gastro Hep Adv. 2022 Apr 15;1(4):618-626. doi: 10.1016/j.gastha.2022.04.007. eCollection 2022.

    PubMed 39132071

  • Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.

    PubMed 20375404

  • Oh DY, Ruth He A, Qin S, Chen LT, Okusaka T, Vogel A, Kim JW, Suksombooncharoen T, Ah Lee M, Kitano M, Burris H, Bouattour M, Tanasanvimon S, McNamara MG, Zaucha R, Avallone A, Tan B, Cundom J, Lee CK, Takahashi H, Ikeda M, Chen JS, Wang J, Makowsky M, Rokutanda N, He P, Kurland JF, Cohen G, Valle JW. Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer. NEJM Evid. 2022 Aug;1(8):EVIDoa2200015. doi: 10.1056/EVIDoa2200015. Epub 2022 Jun 1.

    PubMed 38319896

  • Valle JW, Lamarca A, Goyal L, Barriuso J, Zhu AX. New Horizons for Precision Medicine in Biliary Tract Cancers. Cancer Discov. 2017 Sep;7(9):943-962. doi: 10.1158/2159-8290.CD-17-0245. Epub 2017 Aug 17.

    PubMed 28818953

  • Abou-Alfa GK, Sahai V, Hollebecque A, Vaccaro G, Melisi D, Al-Rajabi R, Paulson AS, Borad MJ, Gallinson D, Murphy AG, Oh DY, Dotan E, Catenacci DV, Van Cutsem E, Ji T, Lihou CF, Zhen H, Feliz L, Vogel A. Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study. Lancet Oncol. 2020 May;21(5):671-684. doi: 10.1016/S1470-2045(20)30109-1. Epub 2020 Mar 20.

    PubMed 32203698

  • Javle M, Roychowdhury S, Kelley RK, Sadeghi S, Macarulla T, Weiss KH, Waldschmidt DT, Goyal L, Borbath I, El-Khoueiry A, Borad MJ, Yong WP, Philip PA, Bitzer M, Tanasanvimon S, Li A, Pande A, Soifer HS, Shepherd SP, Moran S, Zhu AX, Bekaii-Saab TS, Abou-Alfa GK. Infigratinib (BGJ398) in previously treated patients with advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements: mature results from a multicentre, open-label, single-arm, phase 2 study. Lancet Gastroenterol Hepatol. 2021 Oct;6(10):803-815. doi: 10.1016/S2468-1253(21)00196-5. Epub 2021 Aug 3.

    PubMed 34358484

  • Javle M, Borad MJ, Azad NS, Kurzrock R, Abou-Alfa GK, George B, Hainsworth J, Meric-Bernstam F, Swanton C, Sweeney CJ, Friedman CF, Bose R, Spigel DR, Wang Y, Levy J, Schulze K, Cuchelkar V, Patel A, Burris H. Pertuzumab and trastuzumab for HER2-positive, metastatic biliary tract cancer (MyPathway): a multicentre, open-label, phase 2a, multiple basket study. Lancet Oncol. 2021 Sep;22(9):1290-1300. doi: 10.1016/S1470-2045(21)00336-3. Epub 2021 Jul 30.

    PubMed 34339623

  • Abou-Alfa GK, Macarulla T, Javle MM, Kelley RK, Lubner SJ, Adeva J, Cleary JM, Catenacci DV, Borad MJ, Bridgewater J, Harris WP, Murphy AG, Oh DY, Whisenant J, Lowery MA, Goyal L, Shroff RT, El-Khoueiry AB, Fan B, Wu B, Chamberlain CX, Jiang L, Gliser C, Pandya SS, Valle JW, Zhu AX. Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Jun;21(6):796-807. doi: 10.1016/S1470-2045(20)30157-1. Epub 2020 May 13.

    PubMed 32416072

  • Zhu AX, Macarulla T, Javle MM, Kelley RK, Lubner SJ, Adeva J, Cleary JM, Catenacci DVT, Borad MJ, Bridgewater JA, Harris WP, Murphy AG, Oh DY, Whisenant JR, Lowery MA, Goyal L, Shroff RT, El-Khoueiry AB, Chamberlain CX, Aguado-Fraile E, Choe S, Wu B, Liu H, Gliser C, Pandya SS, Valle JW, Abou-Alfa GK. Final Overall Survival Efficacy Results of Ivosidenib for Patients With Advanced Cholangiocarcinoma With IDH1 Mutation: The Phase 3 Randomized Clinical ClarIDHy Trial. JAMA Oncol. 2021 Nov 1;7(11):1669-1677. doi: 10.1001/jamaoncol.2021.3836.

    PubMed 34554208

  • Le DT, Kim TW, Van Cutsem E, Geva R, Jager D, Hara H, Burge M, O'Neil B, Kavan P, Yoshino T, Guimbaud R, Taniguchi H, Elez E, Al-Batran SE, Boland PM, Crocenzi T, Atreya CE, Cui Y, Dai T, Marinello P, Diaz LA Jr, Andre T. Phase II Open-Label Study of Pembrolizumab in Treatment-Refractory, Microsatellite Instability-High/Mismatch Repair-Deficient Metastatic Colorectal Cancer: KEYNOTE-164. J Clin Oncol. 2020 Jan 1;38(1):11-19. doi: 10.1200/JCO.19.02107. Epub 2019 Nov 14.

    PubMed 31725351

  • Lamarca A, Kapacee Z, Breeze M, Bell C, Belcher D, Staiger H, Taylor C, McNamara MG, Hubner RA, Valle JW. Molecular Profiling in Daily Clinical Practice: Practicalities in Advanced Cholangiocarcinoma and Other Biliary Tract Cancers. J Clin Med. 2020 Sep 3;9(9):2854. doi: 10.3390/jcm9092854.

    PubMed 32899345

  • Strickler JH, Loree JM, Ahronian LG, Parikh AR, Niedzwiecki D, Pereira AAL, McKinney M, Korn WM, Atreya CE, Banks KC, Nagy RJ, Meric-Bernstam F, Lanman RB, Talasaz A, Tsigelny IF, Corcoran RB, Kopetz S. Genomic Landscape of Cell-Free DNA in Patients with Colorectal Cancer. Cancer Discov. 2018 Feb;8(2):164-173. doi: 10.1158/2159-8290.CD-17-1009. Epub 2017 Dec 1.

    PubMed 29196463

  • Goyal L, Saha SK, Liu LY, Siravegna G, Leshchiner I, Ahronian LG, Lennerz JK, Vu P, Deshpande V, Kambadakone A, Mussolin B, Reyes S, Henderson L, Sun JE, Van Seventer EE, Gurski JM Jr, Baltschukat S, Schacher-Engstler B, Barys L, Stamm C, Furet P, Ryan DP, Stone JR, Iafrate AJ, Getz G, Porta DG, Tiedt R, Bardelli A, Juric D, Corcoran RB, Bardeesy N, Zhu AX. Polyclonal Secondary FGFR2 Mutations Drive Acquired Resistance to FGFR Inhibition in Patients with FGFR2 Fusion-Positive Cholangiocarcinoma. Cancer Discov. 2017 Mar;7(3):252-263. doi: 10.1158/2159-8290.CD-16-1000. Epub 2016 Dec 29.

    PubMed 28034880

  • Miller AM, Shah RH, Pentsova EI, Pourmaleki M, Briggs S, Distefano N, Zheng Y, Skakodub A, Mehta SA, Campos C, Hsieh WY, Selcuklu SD, Ling L, Meng F, Jing X, Samoila A, Bale TA, Tsui DWY, Grommes C, Viale A, Souweidane MM, Tabar V, Brennan CW, Reiner AS, Rosenblum M, Panageas KS, DeAngelis LM, Young RJ, Berger MF, Mellinghoff IK. Tracking tumour evolution in glioma through liquid biopsies of cerebrospinal fluid. Nature. 2019 Jan;565(7741):654-658. doi: 10.1038/s41586-019-0882-3. Epub 2019 Jan 23.

    PubMed 30675060

  • Hwang S, Woo S, Kang B, Kang H, Kim JS, Lee SH, Kwon CI, Kyung DS, Kim HP, Kim G, Kim C, Chon HJ. Concordance of ctDNA and tissue genomic profiling in advanced biliary tract cancer. J Hepatol. 2025 Apr;82(4):649-657. doi: 10.1016/j.jhep.2024.10.020. Epub 2024 Oct 21.

    PubMed 39442892

Questions about this trial

What is this clinical trial studying?

An observational study of Biliary Tract Cancer, run by CHA University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hong Jae Chon, MD. PhD (82-31-780-3928, minidoctor@cha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detection of Actionable Genomic Alterations by ctDNA Profiling (time frame: Baseline (within 30 days prior to initiation of systemic therapy or prior to subsequent treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07151118, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

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