Clinical trial NCT05580328: An Exploratory Clinical Study of Photodynamic Therapy Combined With Sonodynamic Therapy in Cholangiocarcinoma
Official title: An Exploratory Clinical Study of Photodynamic Therapy With Hematoporphyrin Injection Combined With Sonodynamic Therapy in the Treatment of Inoperable Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholangiocarcinoma
Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18, male or female
* Patients with advanced cholangiocarcinoma confirmed by imaging, biopsy or cytology (including hilar cholangiocarcinoma, middle and lower segment cholangiocarcinoma, ampullary tumor, etc.) who do not have the conditions for surgical resection due to vascular invasion and metastasis
* Karnofsky score ≥ 70
* The patient voluntarily participated in the trial and signed the informed consent form

Exclusion Criteria:

* The expected life span is less than 3 months
* White blood cells of subjects \< 3.0 × 109/L, or hemoglobin is less than 80 g/L, or neutrophil is less than 1.5 × 109/L, or platelet\<75 × 109/L, or other blood system diseases
* Blood creatinine \> 1.5 times the upper limit of normal value
* In patients with severe liver function damage, ALT and/or AST\>5 times the upper limit of normal value
* Have porphyria or allergy to porphyrin drugs
* Patients with active and untreated infection and/or acute bacterial or fungal infection (except biliary tract infection and cholecystitis) at the time of enrollment
* Severe hypertension (180mmhg / 110mmhg) that has not been controlled after intervention treatment, or serious complications of hypertension, or serious complications of diabetes
* Have serious heart, lung and central nervous system diseases
* Patients with mental illness or mental retardation who cannot correctly describe their feelings or cannot take medicine as instructed by the doctor
* Female patients who have become pregnant or may become pregnant and are unwilling to take reasonable and effective contraceptive measures, or are breastfeeding, or patients and/or sexual partners hope to become pregnant during the study period
* In addition to the above, the investigator determined that the patients were not suitable for this study.

Primary outcomes:
measure: Size of tumor evaluated by CT
timeFrame: CT will be performed at the 24th months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: