RFA Combined With Chemotherapy for Unresectable Cholangiocarcinoma

February 17, 2023 updated by: Jianfeng Yang, First People's Hospital of Hangzhou

Endoscopic Radiofrequency Ablation Combined With Gemcitabine and S-1 in Paitiens for Unresectable Cholangiocarcinoma：A Randomized Open-label Clinical Trial

Extrahepatic cholangiocarcinoma is a malignant tumor that is highly malignant and difficult to diagnose and treat early. Endobiliary radiofrequency ablation (RFA) has been reported to be a beneficial treatment option for palliation of malignant biliary strictures. Within the bile duct, RFA appears to be safe and may result in decreased tumor ingrowth. To date, little is known about the role of the addition of systemic chemotherapy to RFA for cholangiocarcinoma. The aim of this study is to compare the efficacy and safety of RAF combined with Gemcitabine and S-1 in patients with unresectable cholangiocarcinoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Over 60 % of common bile duct (CBD) obstructions are due to malignancy, and the majority of neoplasms are unresectable at the time of diagnosis. Biliary drainage with placement of metal or plastic stents for palliation is the therapy of choice in this set of patients.

Radiofrequency ablation (RFA) is well established method for treatment of some solid tumors, like liver cancer, lung cancer, etc. Recently, an endoscopically applicable radiofrequency probe, HabibTM EndoHBP catheter, was approved for clinical use. RFA uses a high-frequency alternating current to generate heat and achieve coagulative necrosis when in contact with tissue. Many studies showed RFA with biliary stent was a beneficial treatment option for palliation of malignant biliary strictures. However, most of therapeutic effects were expected to delay bile duct obstruction rather than to decrease the tumor. Recently orally available chemotherapeutic agent, S-1, an oral fluoropyrimidine, was reported as effective in patients with bile duct adenocarcinoma. To date, little is known about the role of the addition of systemic chemotherapy to RFA for cholangiocarcinoma.

The aim of this study is to compare the efficacy and safety of RAF combined with Gemcitabine and S-1 in patients with unresectable cholangiocarcinoma

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 31006
        • Hangzhou First People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Obtention of a written informed consent.
  • Patient with histologically proved cholangiocarcinoma ; histologic diagnosis must be proved by biliary brushing, bile cytology, endobiliary biopsy under Spyglass, or by EUS-FNA.
  • Patient with Karnofsky score > 60， ECOG>level 2
  • Patient capable of fill in the quality of life questionnaire
  • For the first time treatment
  • CT, MRCP, EUS and other examinations indicate that the tumor has locally infiltrated large blood vessels and cannot be surgically removed

Exclusion Criteria

  • No written informed consent
  • Patients under or already treated by radiotherapy or chemotherapy treatment for cholangiocarcinoma.
  • Pregnant, parturient or breastfeeding women
  • Serious abnormalities in liver and kidney function and coagulation function
  • The ERCP guide wire cannot pass the stricture due to severe biliary stricture
  • Merge with other malignant tumors
  • Use other treatments that may affect the observation, such as radioactive particles or seed stent implantation, P53 injection, oral chemotherapy, interventional therapy, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RAF combined with gemcitabine and S-1 group
Patients will receive endobiliary radiofrequency ablation ( RFA) followed by plastic stent(s) placement, and be treated with gemcitabine and S-1 within 1 month after RFA.
Device: radiofrequency ablation
All patients underwent biliary sphincterotomy. Cholangiogram was performed to confirm stricture location, length and diameter. The Habib Endo HPB (Hepatobiliary) probe (EMcision, HitchinHerts, UK) was then advanced over a wire at the level of the biliary stricture and ablation using ERBE generator set at 7-10 watts for a time period of 90-120 s was conducted. A 1- to 2-min resting period after energy delivery was allowed before moving the catheter along the length of the stricture to ablate the rest of the stricture. Plastic stent(s) were placed after RFA depending on the location of the malignant obstruction
Drug: Chemotherapy drug
Gemcitabine 1 000 mg/m2 intravenously on day 1，8; S-1 80 mg/m2 was taken orally twice for two weeks. The curative effect was evaluated comprehensively for each 2 cycles of chemotherapy
Other Names:
  • oral fluoropyrimidine
Placebo Comparator: RFA-only gruop
Patients will only receive endobiliary radiofrequency ablation ( RFA) followed by plastic stent(s) placement
Device: radiofrequency ablation
All patients underwent biliary sphincterotomy. Cholangiogram was performed to confirm stricture location, length and diameter. The Habib Endo HPB (Hepatobiliary) probe (EMcision, HitchinHerts, UK) was then advanced over a wire at the level of the biliary stricture and ablation using ERBE generator set at 7-10 watts for a time period of 90-120 s was conducted. A 1- to 2-min resting period after energy delivery was allowed before moving the catheter along the length of the stricture to ablate the rest of the stricture. Plastic stent(s) were placed after RFA depending on the location of the malignant obstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival time
Time Frame: two years
The period from endoscopic treatment to patient death or the last day of study
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: one month
Number of participants with adverse events; type, frequency and intensity of adverse events
one month
Stent patency time
Time Frame: two years
Take the stent placement as the starting point and the stent occlusion confirmed by ERCP as the end point. Record the time interval between the two point
two years
Progression free survival
Time Frame: two years
evaluate the survival time without disease progression
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First People's Hospital of Hangzhou

Collaborators

Xijing Hospital
Changhai Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Eastern Hepatobiliary Surgery Hospital
Hangzhou Cancer Hospital

Investigators

  • Study Director: Xiaofeng Zhang, M.S, First People's Hospital of Hangzhou

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

August 25, 2021

First Submitted That Met QC Criteria

August 25, 2021

First Posted (Actual)

August 31, 2021

Study Record Updates

Last Update Posted (Estimate)

February 20, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-08-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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