Clinical trial · Interventional
S-1 and Photodynamic Therapy in Cholangiocarcinoma
Photodynamic Therapy With S-1 in the Patients With Unresectable Type III or IV Cholangiocarcinoma: A Prospective Randomized Trial With Open Label Control
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
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 |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photodynamic therapy | Procedure | — | UNRESOLVED |
| S-1 Chemotherapy | Drug | — | UNRESOLVED |
| Systemic chemotherapy except S-1 | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 1
- description
- Treatment by combination of photodynamic therapy and S-1 1. PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation 2. S-1 chemotherapy before intolerable complication or definite tumor progression Based on the body surface area, \<1.25m2: 80mg/day, 1.25\~1.5m2: 100mg/day, ≧1.5m2: 120mg/day Given orally twice daily for 14days, followed by 7 days without treatment
- interventionNames
- Drug: S-1 Chemotherapy
- Procedure: Photodynamic therapy
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Treatment by photodynamic therapy only 1. PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation 2. Other managements except systemic chemotherapy were added freely.
- interventionNames
- Procedure: Photodynamic therapy
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic or cytologic diagnosis of cholangiocarcinoma * Not eligible for curative surgery * Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better * No serious or uncontrolled concomitant medical illness * Adequate bone marrow function (absolute neutrophil count ≧1,500 ul, platelet count ≧75,000/ul) * Consent this study in letter Exclusion Criteria: * Another neoplasia * Porphyria * Pregnant or breastfeeding women
References
Publications (1)
- RESULTPark 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. PMID 24485665