Photodynamic Therapy for Cholangiocarcinoma

Cholangiocarcinoma Non-resectable Clinical Trial

Official title:

Evaluation of Bile Duct Patency After Photodynamic Therapy in Unresectable Cholangiocarcinoma：a Prospective Non-randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04860154
• Other study ID #: Photodynamic therapy
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2021
• Est. completion date: May 1, 2024

Study information

• Verified date: September 2023
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: Xun Li, M.D.,Ph.D.
• Phone: +86 13993138612
• Email: drlixun[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of the bile duct patency with photodynamic therapy (PDT) and regular Endoscopic Retrograde Cholangiopancreatography(ERCP) stents in unresectable cholangiocarcinoma.

Description:

Cholangiocarcinoma is a malignant tumor originating from the bile duct epithelium, accounting for about 70% of the malignant tumors of the bile duct system. Patients have no obvious clinical symptoms in the early stage. After late diagnosis, the effective treatment is surgical resection and & or liver transplantation, and chemotherapy is only used as adjuvant or palliative treatment. Some types of cholangiocarcinomas, such as hilar cholangiocarcinomas, are difficult to achieve radical resection due to their anatomical location, early invasions and are prone to recurrence with a poor long-term efficacy after surgery. Therefore, the comprehensive treatment of cholangiocarcinoma by multiple means urgently needs to be explored. In recent years, photodynamic therapy (PDT), as a new local treatment method, has attracted increasing attention. This study investigates the bile duct patency and effectiveness of photodynamic therapy compare with ordinary ERCP treatment for cholangiocarcinoma including the median survival, overall survival, and other indicators of side effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• ERCP cholangiocarcinoma(the tumor is unresectable or patient can't accept surgery in the situation, the tumor can be resected but the patients cannot tolerate surgery);

Exclusion Criteria:

• Proximal cholangiocarcinoma (Bismuth type ?-?, or intra-hepatic cholangiocarcinoma);
• Patients with Karnofsky Performance Scale (KPS) score=70;
• Expected survival=3months;
• Patients with porphyria;
• Coagulation dysfunction (INR> 1.5) and low peripheral blood platelet count(<50×10^9 / L) or using anti-coagulation drugs;
• Bilirubin could not be reduced to less than 100mmol/L within 1 month after drainage;
• Patients have intrahepatic metastasis or distant metastasis;
• Patients with no pathological diagnosis;
• known to allergic to study drug(porphyrin drugs) or other similar and related compounds;
• Other photosensitizers have been used within 4 weeks prior;
• Metal biliary stents were placed previously;
• Patients with contraindications to ERCP;
• Patients with HIV infection;
• Pregnant, parturient, or breastfeeding women;
• Patients complicated with other malignant tumors;
• Patients with severe liver function damage;
• Patients who were in cachexia, liver abscess, or advanced patients who were unable to tolerate PDT;
• Patients with other serious physical or mental illnesses that prevent researchers to enroll them in this study as subjects;
• Patients with other contraindications for photodynamic therapy.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Cholangiocarcinoma Non-resectable

Intervention

Drug:
• Hematoporphyrin
Patients with negative skin test of hematoporphyrin Injection (3.0-5.0mg/Kg plus saline 250 mL intravenous drip, the drip was completed within 1 hour) and keep patients away from the light. The first PDT therapy was performed 24 hours after infusion of hematoporphyrin injection by ERCP. The biliary tumor necrosis was observed and the biliary tract was cleaned up 24 hours later and then PDT therapy showed again if necessary. Multiple plastic stents or bald metal stents will be placed. Follow up regularly after the procedure, PDT therapy would be given again in 3 months.

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Jilin
China	Southwest Hospital, Army Medical University	Chongqing	Chongqing
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Shandong Provincial Third Hospital	Jinan	Shandong
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	Xinhua Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	General Hospital of Taiyuan Iron and Steel Corporation	Taiyuan	Shanxi
China	The First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	The first affiliated hospital of Xi 'an JiaoTong university	Xi'an	Shaanxi
China	General Hospital of Ningxia Medical University	Yingchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
Hepatopancreatobiliary Surgery Institute of Gansu Province

Country where clinical trial is conducted

China, 

References & Publications (4)

Gonzalez-Carmona MA, Bolch M, Jansen C, Vogt A, Sampels M, Mohr RU, van Beekum K, Mahn R, Praktiknjo M, Nattermann J, Trebicka J, Branchi V, Matthaei H, Manekeller S, Kalff JC, Strassburg CP, Weismuller TJ. Combined photodynamic therapy with systemic chemotherapy for unresectable cholangiocarcinoma. Aliment Pharmacol Ther. 2019 Feb;49(4):437-447. doi: 10.1111/apt.15050. Epub 2019 Jan 13. — View Citation

Lu Y, Liu L, Wu JC, Bie LK, Gong B. Efficacy and safety of photodynamic therapy for unresectable cholangiocarcinoma: A meta-analysis. Clin Res Hepatol Gastroenterol. 2015 Dec;39(6):718-24. doi: 10.1016/j.clinre.2014.10.015. Epub 2015 Jun 10. — View Citation

Strand DS, Cosgrove ND, Patrie JT, Cox DG, Bauer TW, Adams RB, Mann JA, Sauer BG, Shami VM, Wang AY. ERCP-directed radiofrequency ablation and photodynamic therapy are associated with comparable survival in the treatment of unresectable cholangiocarcinoma. Gastrointest Endosc. 2014 Nov;80(5):794-804. doi: 10.1016/j.gie.2014.02.1030. Epub 2014 May 15. — View Citation

Talreja JP, Degaetani M, Ellen K, Schmitt T, Gaidhane M, Kahaleh M. Photodynamic therapy in unresectable cholangiocarcinoma: not for the uncommitted. Clin Endosc. 2013 Jul;46(4):390-4. doi: 10.5946/ce.2013.46.4.390. Epub 2013 Jul 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bile duct patency	Patency period of the stents after treatment	3years (every 3 months or obstruction appears)
Primary	Median survival time	The time of the half of the patients survived after initial therapy	3years (every 3 months)
Secondary	Overall survival	The time from initial therapy to death or the end of the study	5years (every 3 months)
Secondary	Karnofsky Performance Scale	The Karnofsky Performance Scale scores range from 0 (death) to 100 (normal). The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is a normal activity with effort and some signs or symptoms of the disease. pre-operation, 1 month, 3 months, 6 months, 9 months, and 12 months after the operation	1year (baseline and every 3 months)
Secondary	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30	EORTCQLQ-C30 score used to assess the quality of life of cancer patients. EORTCQLQ-C30 score contains 30 questions, the first 28 questions include 1-4 points, the lower the score, the better; but the latter two questions include 1-7 points, the higher the score, the better. pre-operation, 1 month, 3 months, 6 months, 9 months, and 12 months after the operation	1year (baseline and every 3 months)
Secondary	The change of weight in kilograms	Weight changes of the patient before and after PDT treatment, pre-operation, 1 month, 3 months, 6 months, 9 months, and 12 months after the operation	1year (baseline and every 3 months)
Secondary	Beck Anxiety Inventory	BAI is a 21-item self-reported questionnaire that measures the existence and severity of symptoms of anxiety. Each of the 21 items on the BAI tool represents an anxiety symptom. A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and; 26 - 63 as "Severe", pre-operation, 1 month, 3 months, 6 months, 9 months and 12 months after the operation	1year (baseline and every 3 months)
Secondary	Cumulative treatment costs	The overall treatment costs from initial PDT to death or the end of the study	5years (baseline and in each year)