A new clinical trial aiming to assess the effectiveness of photodynamic therapy combined with sonodynamic therapy in the treatment of cholangiocarcinoma (CCA) will start shortly.
The study will include patients, who are 18 years of age or older with advanced nonresectable CCA due to vascular invasion or metastasis. CCA diagnosis must be confirmed by either biopsy, cytology, or imaging studies. The study will not be limited to intrahepatic hepatocarcinoma, hilar CCA, middle and lower segment CCA, as well as ampullary tumors will also be included.
Exclusion criteria included a lifespan under 3 months, severe cytopenia, elevated creatinine or hepatic enzymes, severe heart disease, severe hypertension, severe lung disease, central nervous system disorders, pregnancy, porphyria, mental illness, and mental retardation.
Read more about CCA therapies
The study aims to assess treatment effectiveness using computed tomography to measure tumor size after 24 months of treatment, which will be the primary outcome measure. Secondary outcome measures are yet to be disclosed.
Photodynamic therapy will be carried out with the drug hematoporphyrin. In this trial, patients will receive a dose of 5mg/kg intravenously 2 to 3 days before laser irradiation. The authors hypothesize that its effect will be enhanced by the combination with sonodynamic therapy.
Enrolled patients will receive combined photodynamic and sonodynamic therapy at least one time. Researchers will determine if a second dose is appropriate depending on the treatment tolerance of each patient and treatment response. Candidates for a second dose will receive it 6 months after the initial dose.
Follow-up evaluations are scheduled to occur every three months after the beginning of treatment up to 24 months. Examinations will include routine blood workups, urine workups, electrocardiograms, vital sign measuring, and quality-of-life assessments through standardized questionnaires.
The clinical trial is scheduled to start in December 2022, and it is expected to be completed by October 2024.
An Exploratory Clinical Study of Photodynamic Therapy Combined With Sonodynamic Therapy in Cholangiocarcinoma. ClinicalTrials.gov. October 14, 2022. Accessed October 22, 2022.