NCT05580328

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

Status unknown NA Last updated 14 November 2022

What this trial tests

NA trial testing Hematoporphyrin Injection actived by photodynamic therapy combined with Sonodynamic Therapy in Cholangiocarcinoma in 10 participants. Status unknown.

Timeline

1 December 2022

Primary endpoint
1 October 2024

1 October 2024

Quick facts

Lead sponsor	Second Affiliated Hospital of Guangzhou Medical University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 December 2022
Primary completion	1 October 2024
Estimated completion	1 October 2024

Drugs / interventions tested

• Hematoporphyrin Injection actived by photodynamic therapy combined with Sonodynamic Therapy — full drug profile →

Conditions studied

• Cholangiocarcinoma — all drugs for Cholangiocarcinoma →

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Who can join

18 and older, any sex, with Cholangiocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nanosensitizer-mediated augmentation of sonodynamic therapy efficacy and antitumor immunity.
   Li Y, Chen W, Kang Y, Zhen X, et al · · 2023 · cited 130× · PMID 37914681 · DOI 10.1038/s41467-023-42509-7
2. Trial watch: an update of clinical advances in photodynamic therapy and its immunoadjuvant properties for cancer treatment.
   Penetra M, Arnaut LG, Gomes-da-Silva LC. · · 2023 · cited 36× · PMID 37346450 · DOI 10.1080/2162402x.2023.2226535
3. Nanosensitizer-assisted sonodynamic therapy for breast cancer.
   Yu J, Hu JR, Tian Y, Lei YM, et al · · 2025 · cited 8× · PMID 40197318 · DOI 10.1186/s12951-025-03311-3
4. One-dimensional nanosonosensitizer boosted multiple branches of immune responses against MHC-deficient immune-evasive urologic tumor.
   Yang W, Di S, Yang Z, Cao J, et al · · 2025 · cited 6× · PMID 39879294 · DOI 10.1126/sciadv.ado7373
5. Novel Spatially Asymmetric Copper Bismuthate-Mediated Augmentation of Energy Conversion to Realize "Three-Step" Tumor Suppression.
   Wang J, Zheng H, Hu G, Yang X, et al · · 2024 · cited 6× · PMID 38654629 · DOI 10.1002/advs.202402599
6. Focused ultrasound-induced cell apoptosis for the treatment of tumours.
   Wang N, Luo L, Xu X, Zhou H, et al · · 2024 · cited 1× · PMID 39184389 · DOI 10.7717/peerj.17886
7. Defect-Rich 2D Layered Double Hydroxides Enhance Sonodynamic Antibacterial Therapy.
   Liu Q, Yang Y, Zhao R, Huang L, et al · · 2026 · PMID 41556229 · DOI 10.1002/advs.202524216