drugset / Trial / NCT05028439
RFA Combined With Chemotherapy for Unresectable Cholangiocarcinoma
Completed
70 enrolled
First People's Hospital of Hangzhou
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · collabChanghai Hospital · collabEastern Hepatobiliary Surgery Hospital · collabHangzhou Cancer Hospital · collabXijing Hospital · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
Extrahepatic cholangiocarcinoma is a malignant tumor that is highly malignant and difficult to diagnose and treat early. Endobiliary radiofrequency ablation (RFA) has been reported to be a beneficial treatment option for palliation of malignant biliary strictures. Within the bile duct, RFA appears to be safe and may result in decreased tumor ingrowth. To date, little is known about the role of the addition of systemic chemotherapy to RFA for cholangiocarcinoma. The aim of this study is to compare the efficacy and safety of RAF combined with Gemcitabine and S-1 in patients with unresectable cholangiocarcinoma.
Timeline
- Start
- 2020-01-01
- Primary completion
- 2022-12-01
- Completion
- 2022-12-30
Publications
- Background Laquiere A, Boustiere C, Leblanc S, Penaranda G, Desilets E, Prat F. Safety and feasibility of endoscopic biliary radiofrequency ablation treatment of extrahepatic cholangiocarcinoma. Surg Endosc. 2016 Mar;30(3):1242-8. doi: 10.1007/s00464-015-4322-7. Epub 2015 Jul 11.
- Background Butros SR, Shenoy-Bhangle A, Mueller PR, Arellano RS. Radiofrequency ablation of intrahepatic cholangiocarcinoma: feasability, local tumor control, and long-term outcome. Clin Imaging. 2014 Jul-Aug;38(4):490-494. doi: 10.1016/j.clinimag.2014.01.013. Epub 2014 Feb 7.
- Background Strand DS, Cosgrove ND, Patrie JT, Cox DG, Bauer TW, Adams RB, Mann JA, Sauer BG, Shami VM, Wang AY. ERCP-directed radiofrequency ablation and photodynamic therapy are associated with comparable survival in the treatment of unresectable cholangiocarcinoma. Gastrointest Endosc. 2014 Nov;80(5):794-804. doi: 10.1016/j.gie.2014.02.1030. Epub 2014 May 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | S-1 | Small molecule | 80 mg/m2 | Oral |