Clinical trial · Interventional
Second-line Therapy of Unresectable Cholangiocarcinoma by RADIOEMBOLIZATION
Efficacy and Tolerance of RADIOEMBOLIZATION for Patients With Unresectable Intrahepatic Cholangiocarcinoma With Tumor Progression After First-line Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Not enough inclusion
Summary
Brief summary (as posted)
Cholangiocarcinoma (CCK) is a rare tumor (2000 new cases/year in France) with very poor prognosis (overall survival \< 3% at 5 years). Less than 20% of patients may benefit from curative surgical resection and most patients have medical treatment by palliative treatment by palliative chemotherapy. It is not standard first-line chemotherapy validated for unresectable CCK, but the best objective response rate (OR) and overall survival (OS) are observed with gemcitabine and platinum associations (OR 24 to 36% and OS between 9.5 to 15.4 months). In case of tumor progression ater this first line therapy, no treatment is currently being validated. RADIOEMBOLIZATION (RE) is a new, transarterial approach to radiation therapy using 90 Yttrium microspheres. In the patients with unresectable CCK , the first pilot studies showed interesting results with rates of OR 45 to 90% and a median OS of 14.9 mots and an acceptable safety. Study Hypothesis : RE could help achieve tumor stabilization in patients with intra-hepatic CCK in tumor progression after first-line therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholestasis, Progressive Familial Intrahepatic 3 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Yttrium microsphere injection | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Yttrium microsphere injection
- interventionNames
- Device: Yttrium microsphere injection
Primary outcomes (1)
- measure
- Progression -free survival at 6 months (from date of inclusion)
- timeFrame
- 6 months
- description
- Progression -free survival defined by the number of patients alive at 6 months without tumor progression documented on imaging evaluation ( MRI or CT) using RECIST criteria version 1.1.
Secondary outcomes (3)
- measure
- Tumor response at 1 month, 2 months, 4 months, 6 months
- timeFrame
- 1 month, 2 months, 4 months, 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Unresectable intra-hepatic CCK histologically proven * Tumor progression documented on imaging evaluation ( CT or MRI) according to RECIST criteria version 1.1 after first-line therapy * Performance status \< 2 ; 4) Bilirubin \< 36 micromol/l * age \> 18 years Exclusion Criteria: * Extra-hepatic metastases * Uncontrolled biliary obstruction * Contra-indications to RE.
References
Publications (9)
- BACKGROUNDWest J, Wood H, Logan RF, Quinn M, Aithal GP. Trends in the incidence of primary liver and biliary tract cancers in England and Wales 1971-2001. Br J Cancer. 2006 Jun 5;94(11):1751-8. doi: 10.1038/sj.bjc.6603127. PMID 16736026
- BACKGROUNDKhan SA, Thomas HC, Davidson BR, Taylor-Robinson SD. Cholangiocarcinoma. Lancet. 2005 Oct 8;366(9493):1303-14. doi: 10.1016/S0140-6736(05)67530-7. PMID 16214602
- BACKGROUNDPatel T. Increasing incidence and mortality of primary intrahepatic cholangiocarcinoma in the United States. Hepatology. 2001 Jun;33(6):1353-7. doi: 10.1053/jhep.2001.25087. PMID 11391522
- BACKGROUNDGores GJ. Cholangiocarcinoma: current concepts and insights. Hepatology. 2003 May;37(5):961-9. doi: 10.1053/jhep.2003.50200. No abstract available. PMID 12717374
- BACKGROUNDKhan SA, Davidson BR, Goldin R, Pereira SP, Rosenberg WM, Taylor-Robinson SD, Thillainayagam AV, Thomas HC, Thursz MR, Wasan H; British Society of Gastroenterology. Guidelines for the diagnosis and treatment of cholangiocarcinoma: consensus document. Gut. 2002 Nov;51 Suppl 6(Suppl 6):VI1-9. doi: 10.1136/gut.51.suppl_6.vi1. No abstract available. PMID 12376491
- BACKGROUNDValle 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. PMID 20375404
- BACKGROUNDDucreux M, Van Cutsem E, Van Laethem JL, Gress TM, Jeziorski K, Rougier P, Wagener T, Anak O, Baron B, Nordlinger B; EORTC Gastro Intestinal Tract Cancer Group. A randomised phase II trial of weekly high-dose 5-fluorouracil with and without folinic acid and cisplatin in patients with advanced biliary tract carcinoma: results of the 40955 EORTC trial. Eur J Cancer. 2005 Feb;41(3):398-403. doi: 10.1016/j.ejca.2004.10.026.