Clinical trial

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

Name

2020-08-17

Description

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.

Trial arms

Trial start

2020-01-01

Estimated PCD

2022-12-01

Trial end

2022-12-30

Status

Completed

Treatment

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

Arms:

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

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

Arms:

RAF combined with gemcitabine and S-1 group

Other names:

oral fluoropyrimidine

Size

Primary endpoint

survival time

two years

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ACTUAL'}}

Updated at

2023-02-21

1 organization

1 drug

1 indication

Organization

First People's Hospital of Hangzhou

Drug

AN0025

Indication

Cholangiocarcinoma