A new nonrandomized clinical trial that aims to compare the clinical efficacy and safety of endoscopic photodynamic therapy (PDT) and radiofrequency ablation (RFA) for extrahepatic cholangiocarcinoma (CCA) recently opened.
Currently, patients with unresectable extrahepatic CCA have a median survival of approximately 6 months, thus creating a need for therapies capable of managing tumor growth and prolonging stent patency. Both PDT and RFA have been proven to improve survival and prolong stent patency in patients with extrahepatic CCA. However, the literature comparing the efficacy and safety of these endoscopic approaches is scarce.
The clinical trial aims to include 70 patients with a confirmed diagnosis of extrahepatic CCA, either by histology or cytology. In all of the included patients, tumors must have been deemed unresectable after assessment with computed tomography or endoscopic ultrasound.
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All patients must have sufficient bone marrow function and must not have received any previous treatments. Patients with evidence of metastasis, other malignant tumors, or previous gastrointestinal diversion will be excluded.
Read more about CCA therapies
Patients included in the trial will be divided into 3 parallel groups. The first group will receive endoscopic retrograde cholangiopancreatography (ERCP) PDT. Photoactivation will be performed at 640 nm with the help of a diode laser at a light dose of 180 J/cm2 at a power density of 300 mW/cm2. The second group will receive ERCP-guided RFA. The third group will receive a combination of RFA and PDT.
The primary outcome measure of the study is overall survival, defined as the interval between treatment initiation with PDT, RFA, or combined PDT and RFA and death. Secondary outcome measures include the number of patients that experience adverse effects and progression-free survival, defined as the time from treatment initiation to disease progression or death.
The trial is estimated to start on January 1, 2023, and the estimated primary completion date is December 31, 2025.
Reference
Safety and efficacy of PDT vs RFA vs PDT+RFA for the treatment of extrahepatic cholangiocarcinoma. ClinicalTrials.gov. August 29, 2022. Accessed September 6, 2022.
