Clinical trial · Interventional
Clinical Effect and Safety of PDT and RFA for Unresectable EHCC
Clinical Effect and Safety of Photodynamic Therapy With Radiofrequency Ablation for Unresectable Extrahepatic Cholangiocarcinoma
- 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)
The prognosis of patients with advanced unresectable EHCC is very poor with a median survival of 3 to 6 months. Active control of tumor growth is the key to extending stent patency and survival for patients with unresectable locally advanced EHCC. Photodynamic therapy (PDT) is by far the only modality that has shown to improve stent patency as well as over survival (OS) in patients with cholangiocarcinoma. In recent years, many studies have shown that endoscopic radiofrequency ablation (RFA) extends stent patency and possibly the survival of patients with malignant biliary obstruction. However, there are few reports comparing the clinical efficacy and advers event of these two endoscopic treatment.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photodynamic therapy | Procedure | — | UNRESOLVED |
| radiofrequency ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- PDT group
- description
- Patients in PDT group underwnt PDT
- interventionNames
- Procedure: Photodynamic therapy
- type
- EXPERIMENTAL
- label
- RFA group
- description
- Patients in RFA group underwent RFA
- interventionNames
- Procedure: radiofrequency ablation
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- two years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * histologically or cytologically confirmed cholangiocarcinoma; * unresectable cholangiocarcinoma due to local infiltration of major vessels according to computed tomography (CT), magnetic resonance cholangiopancreatography (MRCP), or endoscopic ultrasound（EUS）; * no previous treatment; * adequate bone marrow and organ function (white blood cells\>4.0×109/L, hemoglobin\>90 g/L, and platelets\>75×109/L, serum creatinine\<2.0 mg/dl); * a Karnofsky performance status (KPS) score ≥ 50; * signed written informed consent. Exclusion Criteria: * imaging examination (CT, MRCP, EUS) showed distant metastasis of liver, lung and other organs; * coexistent with other malignant tumors; * pregnant or nursing women; * previous gastrointestinal diversion; * participation in another study during the month before enrollment in this study; * alcohol and/or substance abuse or potentially poor compliance per a doctor's judgment.
References
Publications (0)
Data not yet available