RFA Combined With Chemotherapy for Unresectable Cholangiocarcinoma

NCT05028439 | Completed DMC

• 1 other identifier: 2020-08-17
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholangiocarcinoma

Keywords

biliary tract cancer; radiofrequency ablation; S-1; Gemcitabine

Outcome Measures

Primary Outcomes (1)

• survival time

  The period from endoscopic treatment to patient death or the last day of study

  two years

Secondary Outcomes (3)

• Adverse events

  one month

• Stent patency time

  two years

• Progression free survival

  two years

Study Arms (2)

RAF combined with gemcitabine and S-1 group

EXPERIMENTAL

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; Drug: Chemotherapy drug

RFA-only gruop

PLACEBO COMPARATOR

Patients will only receive endobiliary radiofrequency ablation ( RFA) followed by plastic stent(s) placement

Device: radiofrequency ablation

Interventions

radiofrequency ablation DEVICE

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

RAF combined with gemcitabine and S-1 group; RFA-only gruop

Chemotherapy drug 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

Also known as: oral fluoropyrimidine

RAF combined with gemcitabine and S-1 group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead
• Hangzhou Cancer Hospital: collaborator
• Changhai Hospital: collaborator
• Eastern Hepatobiliary Surgery Hospital: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator
• Xijing Hospital: collaborator

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 31006, China

Location

Related Publications (3)

• Laquiere A, Boustiere C, Leblanc S, Penaranda G, Desilets E, Prat F. Safety and feasibility of endoscopic biliary radiofrequency ablation treatment of extrahepatic cholangiocarcinoma. Surg Endosc. 2016 Mar;30(3):1242-8. doi: 10.1007/s00464-015-4322-7. Epub 2015 Jul 11.

  PMID: 26162420 BACKGROUND

• Butros SR, Shenoy-Bhangle A, Mueller PR, Arellano RS. Radiofrequency ablation of intrahepatic cholangiocarcinoma: feasability, local tumor control, and long-term outcome. Clin Imaging. 2014 Jul-Aug;38(4):490-494. doi: 10.1016/j.clinimag.2014.01.013. Epub 2014 Feb 7.

  PMID: 24637151 BACKGROUND

• 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.

  PMID: 24836747 BACKGROUND

MeSH Terms

Conditions

Cholangiocarcinoma; Biliary Tract Neoplasms

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Xiaofeng Zhang, M.S

  First People's Hospital of Hangzhou

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 31, 2021
• Study Start: January 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 30, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)