An Exploratory Clinical Study of Photodynamic Therapy Combined With Sonodynamic Therapy in Cholangiocarcinoma

Cholangiocarcinoma Clinical Trial

Official title: An Exploratory Clinical Study of Photodynamic Therapy With Hematoporphyrin Injection Combined With Sonodynamic Therapy in the Treatment of Inoperable Cholangiocarcinoma

Status Not yet recruiting

Clinical Trial Summary

After enrollment, they received photodynamic therapy and sonodynamic therapy for a maximum of 2 times, and the longest treatment time was 6 months.The investigator will judge whether the second photodynamic therapy+ sonodynamic therapy treatment treatment is necessary according to the tolerance and tumor progress of the subject. The second photodynamic therapy+ sonodynamic therapy treatmentwill be carried out at the end of the sixth month. After the treatment period, the patients will be followed up once in the first, third and sixth months respectively, and then every three months. The observation and follow-up were carried out from the first subject after randomization to the end of 24 months after the last case.

The inspection and follow-up evaluation on the 7th day of the treatment period, including vital sign examination, blood routine examination, urine routine examination, blood biochemical examination, electrocardiogram examination, recording the number of times of plastic stent/metal stent drainage/drainage tube replacement, evaluation of physical status scale, evaluation of quality-of-life scale, recording concomitant medication and adverse events.

At the end of the first, third and sixth month, you need to come to the hospital for follow-up evaluation. In the test group, the investigator shall judge whether the second photodynamic therapy is needed at the end of the sixth month according to the tolerance and tumor progression of the subject. Before receiving the next photodynamic therapy, your body and quality of life must be evaluated according to KPS score and quality of life scale Arrange laboratory and relevant examinations. If the second photodynamic therapy is needed, continue to record the concomitant medication and adverse events at this stage.

During the follow-up period, after the longest treatment period of 6 months, a follow-up was conducted every 3 months until the end of 24 months after the last subject was enrolled in the scheme. Your survival, replacement of plastic stent/metal stent/drainage tube, biliary drainage, treatment methods for cholangiocarcinoma and serious adverse events were recorded during the follow-up.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Cholangiocarcinoma

• NCT number: NCT05580328
• Study type: Interventional
• Source: Second Affiliated Hospital of Guangzhou Medical University
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Completion date: October 1, 2024