Clinical trial · Interventional
Neoadjuvant PDT in the Treatment of Cholangiocarcinoma
A Prospective Randomized Controlled Study of Neoadjuvant PDT in the Treatment of 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)
For patients with locally advanced cholangiocarcinoma with resectable margins, patients who meet the selection criteria are randomly divided into two groups A and B. Group A: neoadjuvant PDT therapy combined with radical surgery; Group B: radical surgery. This study aims to explore the clinical effectiveness and safety of neoadjuvant photodynamic therapy for cholangiocarcinoma, as well as its role in destroying local tumors and enhancing systemic inflammation.
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 Resectable | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant PDT + radical surgery | Procedure | — | UNRESOLVED |
| Radical surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- neoadjuvant PDT + radical surgery
- description
- Photodynamic therapy for neoadjuvant treatment of cholangiocarcinoma
- interventionNames
- Procedure: Neoadjuvant PDT + radical surgery
- type
- ACTIVE_COMPARATOR
- label
- radical surgery
- description
- Patients with cholangiocarcinoma undergo radical surgical resection
- interventionNames
- Procedure: Radical surgery
Primary outcomes (3)
- measure
- R0 resection rate
- timeFrame
- During operation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with age between 18 to 75 years; * Patients'gender was not limited; * Patients with locally advanced cholangiocarcinoma who have a clear diagnosis of the primary disease and require surgical resection or potential surgical resection; * No history of radiotherapy and chemotherapy; * Willing to accept this clinical trial, sign informed consent and be able to cooperate with follow-up. Exclusion Criteria: * Women during pregnancy or breastfeeding, and those with mental illness; * Patients allergic to porphyrin drugs, porphyria; * Long-term use of glucocorticoids or autoimmune suppression; * Surgical contraindication, including: Child-Pugh C with hepatic encephalopathy Anyone with heart, lung, kidney dysfunction or other organ dysfunction, and cannot tolerate surgery.Hepatic ducts stone disease, who was diagnosed as Acute Cholangitis of Severe Type, especially complicated with bacteremia or septic shock. End stage disease, complicated with biliary cirrhosis or portal hypertension.Patients with long- term obstructive jaundice, dehydration, electrolyte disturbance or coagulation defects; Patients have the tendency or history of bleeding.
References
Publications (2)
- BACKGROUNDWiedmann M, Caca K, Berr F, Schiefke I, Tannapfel A, Wittekind C, Mossner J, Hauss J, Witzigmann H. Neoadjuvant photodynamic therapy as a new approach to treating hilar cholangiocarcinoma: a phase II pilot study. Cancer. 2003 Jun 1;97(11):2783-90. doi: 10.1002/cncr.11401. PMID 12767091
- BACKGROUNDWagner A, Wiedmann M, Tannapfel A, Mayr C, Kiesslich T, Wolkersdorfer GW, Berr F, Hauss J, Witzigmann H. Neoadjuvant Down-Sizing of Hilar Cholangiocarcinoma with Photodynamic Therapy--Long-Term Outcome of a Phase II Pilot Study. Int J Mol Sci. 2015 Nov 6;16(11):26619-28. doi: 10.3390/ijms161125978. PMID 26561801