S-1 and Photodynamic Therapy in Cholangiocarcinoma

Phase 3 Completed 43 enrolled Asan Medical Center

RandomizedParallel-groupSingle-blindTreatment

Summary

In patients with unresectable perihilar cholangiocarcinoma, photodynamic therapy with biliary stent has been known for palliation of jaundice and improving survival. But most of therapeutic effects were expected to delay bile duct obstruction rather than to decrease the tumor. Recently orally available chemotherapeutic agent, S-1 was reported as effective in patients with bile duct adenocarcinoma. The investigators' aims of study evaluate the combined effect of photodynamic therapy and S-1.

Timeline

Start: 2009-02
Primary completion: 2013-07
Completion: 2013-08

Outcome

Met primary endpoint

paper The UHC patients treated with PDT plus S-1 showed higher 1-year survival rate compared with the patients treated with PDT alone (76.2% versus 32%, P=0.003) PMID 24485665 ↗

Publications

Results Park DH, Lee SS, Park SE, Lee JL, Choi JH, Choi HJ, Jang JW, Kim HJ, Eum JB, Seo DW, Lee SK, Kim MH, Lee JB. Randomised phase II trial of photodynamic therapy plus oral fluoropyrimidine, S-1, versus photodynamic therapy alone for unresectable hilar cholangiocarcinoma. Eur J Cancer. 2014 May;50(7):1259-68. doi: 10.1016/j.ejca.2014.01.008. Epub 2014 Jan 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	S-1	Small molecule	80 mg	Oral
Subject	S-1	Small molecule	100 mg	Oral
Subject	S-1	Small molecule	120 mg	Oral