NCT06168292

Brief Summary

\[Study objectives\] To evaluate the efficacy and safety of the combined treatment of radiotherapy and endoscopic intraductal radiofrequency ablation in patients with locoregional extrahepatic cholangiocarcinoma.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
50mo left

Started Apr 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Apr 2024Jun 2030

First Submitted

Initial submission to the registry

November 26, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

4.2 years

First QC Date

November 26, 2023

Last Update Submit

June 16, 2025

Conditions

Biliary Tract CarcinomaRadiotherapyRadio-frequency Ablation

Outcome Measures

Primary Outcomes (1)

  • 2-year local control rate

    2-year local control rate

    At 2 years from the date of study enrollment

Secondary Outcomes (5)

  • 1-year local control rate

    At 1 years from the date of study enrollment

  • Overall survival

    The time point of death from any cause from the study enrollment date, whichever occurs first, up to 2 years

  • Progression-free survival

    The time point of the date of study enrollment until disease progression or death from any cause, whichever occurs first, up to 2 years

  • Local progression-free survival

    The time point of the date of study enrollment until locoregional progression or death from any cause, whichever occurs first, up to 2 years

  • Period of Stent patency

    The time point of the date of biliary stent placement after ID-RFA to the occurrence of stent dysfunction, up to 2 years

Study Arms (1)

Experimental

EXPERIMENTAL

The clinical study will be conducted in the following order. Of patients with extrahepatic cholangiocarcinoma requiring biliary drainage, those who meet the inclusion criteria and consent to the study will be enrolled in the study and hospitalized to undergo endoscopic biliary drainage. The histologic or cytologic examination will be performed at the time of the first biliary drainage, and the extent of the cholangiocarcinoma lesion will be assessed during the procedure. After the diagnosis of extrahepatic cholangiocarcinoma, ID-RFA will be performed, and a biliary stent will be inserted for biliary drainage. Radiotherapy will be performed within 1 month of ID-RFA.

Procedure: ID-RFA and Radiotherapy

Interventions

ID-RFA and RadiotherapyPROCEDURE

The histologic or cytologic examination will be performed at the time of the first biliary drainage, and the extent of the cholangiocarcinoma lesion will be assessed during the procedure. After the diagnosis of extrahepatic cholangiocarcinoma, ID-RFA will be performed, and a biliary stent will be inserted for biliary drainage. Radiotherapy will be performed within 1 month of ID-RFA.

Experimental

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 20 years of age or older, who voluntarily agree to participate in the study and sign the informed consent.
  • Patients with cytopathologically diagnosed inoperable extrahepatic cholangiocarcinoma

You may not qualify if:

  • Patients who refuse to sign the informed consent
  • Patients with metastatic cancer (stage IV) or malignant ascites
  • Patients with intrahepatic cholangiocarcinoma
  • Patients who are unable to undergo endoscopic procedures as determined by the investigator.
  • Patients with a life expectancy of 3 months or less
  • Patients with ID-RFA contraindications: pacemaker, pregnancy, uncorrected bleeding tendency (PT INR \> 1.5, platelets \< 50,000/mm3)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center, Korea

Goyang-si, Other, 10408, South Korea

RECRUITING

Related Publications (12)

  • Prezzano KM, Prasad D, Hermann GM, Belal AN, Alberico RA. Radiofrequency Ablation and Radiation Therapy Improve Local Control in Spinal Metastases Compared to Radiofrequency Ablation Alone. Am J Hosp Palliat Care. 2019 May;36(5):417-422. doi: 10.1177/1049909118819460. Epub 2018 Dec 13.

    PMID: 30541334BACKGROUND

  • Hiraki T, Gobara H, Iguchi T, Fujiwara H, Matsui Y, Kanazawa S. Radiofrequency ablation for early-stage nonsmall cell lung cancer. Biomed Res Int. 2014;2014:152087. doi: 10.1155/2014/152087. Epub 2014 Jun 3.

    PMID: 24995270BACKGROUND

  • Autorino R, Mattiucci GC, Ardito F, Balducci M, Deodato F, Macchia G, Mantini G, Perri V, Tringali A, Gambacorta MA, Tagliaferri L, Giuliante F, Morganti AG, Valentini V. Radiochemotherapy with Gemcitabine in Unresectable Extrahepatic Cholangiocarcinoma: Long-term Results of a Phase II Study. Anticancer Res. 2016 Feb;36(2):737-40.

    PMID: 26851032BACKGROUND

  • Cho JH, Jeong S, Kim EJ, Kim JM, Kim YS, Lee DH. Long-term results of temperature-controlled endobiliary radiofrequency ablation in a normal swine model. Gastrointest Endosc. 2018 Apr;87(4):1147-1150. doi: 10.1016/j.gie.2017.09.013. Epub 2017 Sep 25.

    PMID: 28958907BACKGROUND

  • Kim EJ, Chung DH, Kim YJ, Kim YS, Park YH, Kim KK, Cho JH. Endobiliary radiofrequency ablation for distal extrahepatic cholangiocarcinoma: A clinicopathological study. PLoS One. 2018 Nov 15;13(11):e0206694. doi: 10.1371/journal.pone.0206694. eCollection 2018.

    PMID: 30439965BACKGROUND

  • Sofi AA, Khan MA, Das A, Sachdev M, Khuder S, Nawras A, Lee W. Radiofrequency ablation combined with biliary stent placement versus stent placement alone for malignant biliary strictures: a systematic review and meta-analysis. Gastrointest Endosc. 2018 Apr;87(4):944-951.e1. doi: 10.1016/j.gie.2017.10.029. Epub 2017 Nov 3.

    PMID: 29108980BACKGROUND

  • Yang J, Wang J, Zhou H, Zhou Y, Wang Y, Jin H, Lou Q, Zhang X. Efficacy and safety of endoscopic radiofrequency ablation for unresectable extrahepatic cholangiocarcinoma: a randomized trial. Endoscopy. 2018 Aug;50(8):751-760. doi: 10.1055/s-0043-124870. Epub 2018 Jan 17.

    PMID: 29342492BACKGROUND

  • Lee YN, Jeong S, Choi HJ, Cho JH, Cheon YK, Park SW, Kim YS, Lee DH, Moon JH. The safety of newly developed automatic temperature-controlled endobiliary radiofrequency ablation system for malignant biliary strictures: A prospective multicenter study. J Gastroenterol Hepatol. 2019 Aug;34(8):1454-1459. doi: 10.1111/jgh.14657. Epub 2019 Apr 14.

    PMID: 30861593BACKGROUND

  • Klement RJ, Abbasi-Senger N, Adebahr S, Alheid H, Allgaeuer M, Becker G, Blanck O, Boda-Heggemann J, Brunner T, Duma M, Eble MJ, Ernst I, Gerum S, Habermehl D, Hass P, Henkenberens C, Hildebrandt G, Imhoff D, Kahl H, Klass ND, Krempien R, Lewitzki V, Lohaus F, Ostheimer C, Papachristofilou A, Petersen C, Rieber J, Schneider T, Schrade E, Semrau R, Wachter S, Wittig A, Guckenberger M, Andratschke N. The impact of local control on overall survival after stereotactic body radiotherapy for liver and lung metastases from colorectal cancer: a combined analysis of 388 patients with 500 metastases. BMC Cancer. 2019 Feb 26;19(1):173. doi: 10.1186/s12885-019-5362-5.

    PMID: 30808323BACKGROUND

  • Machtay M, Paulus R, Moughan J, Komaki R, Bradley JE, Choy H, Albain K, Movsas B, Sause WT, Curran WJ. Defining local-regional control and its importance in locally advanced non-small cell lung carcinoma. J Thorac Oncol. 2012 Apr;7(4):716-22. doi: 10.1097/JTO.0b013e3182429682.

    PMID: 22425920BACKGROUND

  • Gkika E, Hawkins MA, Grosu AL, Brunner TB. The Evolving Role of Radiation Therapy in the Treatment of Biliary Tract Cancer. Front Oncol. 2020 Dec 14;10:604387. doi: 10.3389/fonc.2020.604387. eCollection 2020.

    PMID: 33381458BACKGROUND

  • Park N, Jung MK, Kim EJ, Paik WH, Cho JH. In-stent radiofrequency ablation with uncovered metal stent placement for tumor ingrowth/overgrowth causing self-expandable metal stent occlusion in distal malignant biliary obstruction: multicenter propensity score-matched study. Gastrointest Endosc. 2023 Apr;97(4):694-703.e2. doi: 10.1016/j.gie.2022.11.017. Epub 2022 Nov 30.

    PMID: 36460085BACKGROUND

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Sang Myung Woo, M.D

    National Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Myung Woo, M.D

CONTACT

82-31-920-1733wsm@ncc.re.kr

Jung Won Chun, M.D

CONTACT

82-31-920-0887deli4927@ncc.re.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 26, 2023

First Posted

December 13, 2023

Study Start

April 1, 2024

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2030

Last Updated

June 19, 2025

Record last verified: 2025-06

Locations

KR(1)