Cholangiocarcinoma treatment with radiofrequency ablation or photodynamic therapy

Phase 1

Recruiting

Conditions: hilar cholangiocarcinoma
MedDRA version: 20.0Level: LLTClassification code: 10074878Term: Hilar cholangiocarcinoma Class: 10029104
Therapeutic area: Diseases [C] - Neoplasms [C04]
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: CTIS2022-500107-50-00

Lead Sponsor: niversity Of Leipzig

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 258

Inclusion Criteria

Hilar cholangiocarcinoma (cytological or histological confirmation), Surgery is not planned, Age 18 or older, Written informed consent

Exclusion Criteria

Tumour not accessible endoscopically, Planned surgical procedure within the next 30 days, Concurrent eye disease that will require a slit lamp examination within the next 30 days, Prior radiotherapy within the last four weeks, Previous PDT or RFA, Planned liver transplantation, Known hypersensitivity to porphyrins or to any of the other ingredients of the photosensitizer chosen, Leukopenia (< 2000/mm³), Thrombocytopenia (< 100,000/mm³), Severe, uncorrected coagulopathy (at the discretion of the physician), Suspected erosion of major blood vessels, because of the risk of life-threatening mass haemorrhage exists, Porphyria (clinician’s assessment) or other light-exacerbated diseases, Severely impaired liver and or kidney function (at the discretion of the physician), Bedridden for more than 50% of the time (similar to ECOG grade 3)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does PDT or RFA lead to longer survival?;Secondary Objective: How do quality of life and quality of life adjusted years compare between PDT and RFA? What are the most relevant harms with RFA and PDT and how frequently do they occur?;Primary end point(s): The primary endpoint is overall survival, i.e. time from randomization to death from any cause or to the last known date on which the patient was alive. The comparison between arms will be based on the hazard ratio as estimated from a Cox regression model.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Overall survival (complementary perspectives);Secondary end point(s):Days alive and out of hospital up to two years;Secondary end point(s):Quality of Life (QoL) at various points in time after randomization (V2 (14 days), V3 (ca. 3 months), as a function of time after 6 months, adjusting for the baseline value);Secondary end point(s):Quality-adjusted life years (QALYs);Secondary end point(s):Stent patency based on clinician’s assessment (e.g. cholangitis, cholestasis, ultrasound);Secondary end point(s):Laboratory parameters;Secondary end point(s):Pruritus as a function of time up to two years will be considered