Clinical Trials Logo
  1. Home
  2. Cholangiocarcinoma
  3. NCT01739465
  4. Details
NCT01739465 Clinical Trial

Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma

Cholangiocarcinoma Clinical Trial

Official title:
A Randomized Controlled Trial Comparing Endoscopic Biliary Radiofrequency Ablation With Photodynamic Therapy for Inoperable Cholangiocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01739465
Other study ID # RFA2012
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received November 29, 2012
Last updated February 25, 2013
Start date November 2012

Study information
Verified date February 2013
Source Guangzhou Medical University
Contact Huihong Liang, MD
Phone +86-20-34153043
Email beanth@163.com
Is FDA regulated No
Health authority China: Science and Technology Commission of Guangzhou
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare endoscopic radiofrequency ablation with photodynamic therapy for inoperable cholangiocarcinoma

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Age = 18 years old

- Pathologically or radiologically confirmed biliary malignant

- Inoperability by staging

Exclusion Criteria:

- Cholangiocarcinoma with widespread metastasis

- Coagulopathy (INR > 2.0 or prothrombin time > 100 sec or platelet count < 50,000)

- Prior SEMS placement

- Pregnancy

- Eastern Cooperative Oncology Group (ECOG) performance status = 3 )

- Life expectancy < 3months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Self expanding metallic stent (SEMS)
Self expanding metallic stent
• Endoscopic radiofrequency ablation (ERFA)
Endoscopic radiofrequency ablation
• Photodynamic therapy (PDT)
Photodynamic therapy

Locations
Country Name City State
China The Second Hospital of Guangzhou Medical College Guangzhou Guangdong
China The second hospital of Guangzhou Medical college Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary stent patency 6 months No
Secondary overall survival rate 3 years No
See also
  Status Clinical Trial Phase
Recruiting NCT05497531 - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers N/A
Recruiting NCT05678218 - Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Recruiting NCT05179486 - Molecular Epidemiology of Biliary Tree Cancers
Suspended NCT05124743 - HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
Terminated NCT04304781 - Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer Phase 1
Completed NCT03150615 - Enteral Nutrition After Pancreaticoduodenectomy N/A
Completed NCT01912053 - Efficacy Study of Intra-hepatic Administration of Therasphere® in Association With Intravenous Chemotherapy to Treat Cholangiocarcinoma Phase 2
Recruiting NCT01439698 - Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry N/A
Terminated NCT01434459 - Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin Phase 1
Completed NCT01206049 - Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations Phase 2
Recruiting NCT00973713 - Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol Phase 2
Terminated NCT00975039 - Study Using WST11 in Patients With Non-Resectable or Inoperable Cholangiocarcinoma Phase 2
Completed NCT00779454 - Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma Phase 2
Terminated NCT04066491 - Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC Phase 2/Phase 3
Recruiting NCT04340986 - Cohort of Patients With Hepatocellular Carcinoma or Cholangiocarcinoma
Active, not recruiting NCT04526106 - REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03603834 - Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma Phase 2
Recruiting NCT05007106 - MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Phase 2