Safety and Efficacy of PDT vs RFA vs PDT+RFA for the Treatment of Extrahepatic Cholangiocarcinoma

Bile Duct Cancer Clinical Trial

Official title:

Clinical Effect and Safety of Photodynamic Therapy Versus Radiofrequency Ablation Versus Photodynamic Therapy Plus Radiofrequency Ablation for Unresectable Extrahepatic Cholangiocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05519319
• Other study ID #: 2023-01
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 1, 2026

Study information

• Verified date: February 2023
• Source: First People's Hospital of Hangzhou
• Contact: Jianfeng Yang, Doctor
• Phone: +8613454132186
• Email: yjf-1976[@]163.com, yjf3303[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A median survival period of 3 to 6 months is the prognosis for patients with advanced, unresectable EHCC. For patients with locally advanced, unresectable EHCC, effective management of tumor growth is the only option to increase stent patency and survival time. In patients with cholangiocarcinoma, photodynamic therapy (PDT) is therapy that has been shown to improve stent patency and overall survival (OS). Endoscopic radiofrequency ablation (RFA) has been demonstrated in numerous studies to prolong the life spans of individuals with malignant biliary obstruction . In the literature, comparing the clinical efficacy and adverse outcomes of these two endoscopic procedures is rare.

Description:

The lower common bile duct and the hepatic hilar area are the origin of extrahepatic cholangiocarcinoma (EHCC). Patients with advanced, unresectable EHCC have a relatively poor prognosis, with a median survival time of 3 to 6 months. The only way to prolong stent patency and survival for patients with unresectable locally advanced EHCC is by active control of tumor development. The only treatment that has consistently demonstrated an improvement in stent patency and overall survival (OS) in cholangiocarcinoma patients is photodynamic therapy (PDT). The popularity of endoscopic retrograde cholangio-pancreatography (ERCP)-guided radiofrequency ablation (RFA) has grown recently in an effort to increase stent patency and survival time for patients with malignant biliary obstruction.RFA for biliary cholangiocarcinoma has demonstrated safety and effectiveness. Endoscopic RFA has been shown in various studies to prolong stent patency and the survival of patients with malignant biliary obstruction. The clinical effectiveness and adverse events of these two endoscopic treatments have not been compared in many papers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed cholangiocarcinoma;
• unresectable cholangiocarcinoma due to local infiltration of major vessels according to computed tomography (CT), magnetic resonance cholangiopancreatography (MRCP), or endoscopic ultrasound(EUS);
• No previous treatment;
• Adequate bone marrow and organ function (white blood cells>4.0×109/L, hemoglobin>90 g/L, and platelets>75×109/L, serum creatinine<2.0 mg/dl);
• A Karnofsky performance status (KPS) score = 50;
• Signed written informed consent.

Exclusion Criteria:

• Imaging examination (CT, MRCP, EUS) showed distant metastasis of liver, lung and other organs;
• Coexistent with other malignant tumors;
• Pregnant or nursing women;
• Previous gastrointestinal diversion;
• Participation in another study during the month before enrollment in this study;
• Alcohol and/or substance abuse or potentially poor compliance per a doctor's judgment.

Related Conditions & MeSH terms

• Bile Duct Cancer
• Bile Duct Neoplasms
• Cholangiocarcinoma
• Extrahepatic Cholangiocarcinoma

Intervention

Procedure:
• RFA
RFA will be performed
• PDT
PDT will be performed
• RFA combined with PDT
RFA and PDT will be performed

Locations

Country	Name	City	State
China	Hangzhou First People's Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

References & Publications (4)

Chen P, Yang T, Shi P, Shen J, Feng Q, Su J. Benefits and safety of photodynamic therapy in patients with hilar cholangiocarcinoma: A meta-analysis. Photodiagnosis Photodyn Ther. 2022 Mar;37:102712. doi: 10.1016/j.pdpdt.2022.102712. Epub 2022 Jan 5. — View Citation

Gao DJ, Yang JF, Ma SR, Wu J, Wang TT, Jin HB, Xia MX, Zhang YC, Shen HZ, Ye X, Zhang XF, Hu B. Endoscopic radiofrequency ablation plus plastic stent placement versus stent placement alone for unresectable extrahepatic biliary cancer: a multicenter randomized controlled trial. Gastrointest Endosc. 2021 Jul;94(1):91-100.e2. doi: 10.1016/j.gie.2020.12.016. Epub 2020 Dec 24. — View Citation

Li Z, Jiang X, Xiao H, Chen S, Zhu W, Lu H, Cao L, Xue P, Li H, Zhang D. Long-term results of ERCP- or PTCS-directed photodynamic therapy for unresectable hilar cholangiocarcinoma. Surg Endosc. 2021 Oct;35(10):5655-5664. doi: 10.1007/s00464-020-08095-1. E — View Citation

Yang J, Wang J, Zhou H, Zhou Y, Wang Y, Jin H, Lou Q, Zhang X. Efficacy and safety of endoscopic radiofrequency ablation for unresectable extrahepatic cholangiocarcinoma: a randomized trial. Endoscopy. 2018 Aug;50(8):751-760. doi: 10.1055/s-0043-124870. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	OS was defined as the time from initial RFA or PDT to death or the end of the study.	Three years
Secondary	Adverse events	Number of patients with adverse events	Three years
Secondary	Progression-free survival(PFS)	PFS was measured from therapy until the date of disease progression or death	Three years