Comparing treatments for bile duct cancer
Clinical Effect and Safety of Photodynamic Therapy Versus Radiofrequency Ablation Versus Photodynamic Therapy Plus Radiofrequency Ablation for Unresectable Extrahepatic Cholangiocarcinoma
This study is testing which treatment—photodynamic therapy, radiofrequency ablation, or a mix of both—works best for people with bile duct cancer that can’t be surgically removed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | First People's Hospital of Hangzhou Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05519319 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of three treatment approaches for extrahepatic cholangiocarcinoma: photodynamic therapy (PDT), radiofrequency ablation (RFA), and a combination of both. Patients with unresectable cholangiocarcinoma will be treated to assess which method best improves stent patency and overall survival. The study aims to fill a gap in existing literature by directly comparing the clinical outcomes and adverse effects of these two endoscopic procedures.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed unresectable extrahepatic cholangiocarcinoma who have not received prior treatment.
Not a fit: Patients with distant metastasis or other concurrent malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more effective treatment option that improves survival and quality of life.
How similar studies have performed: While there is evidence supporting the effectiveness of PDT and RFA individually, this direct comparison is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hangzhou, Zhejiang
- Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Xiaofeng Zhang — First People's Hospital of Hangzhou
- Study coordinator: Jianfeng Yang, Doctor
- Email: yjf-1976@163.com, yjf3303@zju.edu.cn
- Phone: +8613454132186
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.