Clinical trial NCT05028439: RFA Combined With Chemotherapy for Unresectable Cholangiocarcinoma
Official title: Endoscopic Radiofrequency Ablation Combined With Gemcitabine and S-1 in Paitiens for Unresectable Cholangiocarcinoma：A Randomized Open-label Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholangiocarcinoma
Keywords: biliary tract cancer
radiofrequency ablation
S-1
Gemcitabine
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
Collaborators: name: Hangzhou Cancer Hospital
name: Changhai Hospital
name: Eastern Hepatobiliary Surgery Hospital
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Xijing Hospital
First posted: 2021-08-31
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

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.

Primary outcomes:
measure: survival time
timeFrame: two years
Secondary outcomes:
measure: Adverse events
timeFrame: one month
measure: Stent patency time
timeFrame: two years
measure: Progression free survival
timeFrame: two years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
Study officials:
affiliation: First People's Hospital of Hangzhou
name: Xiaofeng Zhang, M.S
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.