NCT03110510

FOLFIRI as Salvage Treatment in Metastatic Biliary Tract Cancer (BTC) Patients Who Were Failed After Gemcitabine Containing Chemotherapy: A Phase II Single Arm Prospective Study

SAMSUNG MEDICAL CENTER

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

FOLFIRI as a salvage treatment in metastatic biliary tract cancer (BTC) patients who failed gemcitabine containing chemotherapy

Detailed description

Biliary tract carcinoma (BTC) is rare in the Europe and the United States, but not uncommon in Asia and Latin America. The tumor arises from the ductular epithelium of the biliary tree within the liver (intrahepatic), the extrahepatic ducts (extrahepatic), or the gallbladder. Intrahepatic cancer is steadily increasing in the Western world. BTCs carry a poor prognosis with 1-year survival rate of 25%. Although surgery remains the only curative treatment for BTC, most patients present with advanced disease and die within a few months of diagnosis. While a combination of gemcitabine and platinum agents seems to be a conclusive treatment option as first-line treatment until now, the role or the optimal regimen for second-line treatment has not been established. Few articles about second line treatment in advanced BTC were reported. French group recently reported the retrospective analysis of FOLFIRI regimen in advanced BTC patients. However, there is no prospective trial of FOLFIRI regimen to evaluate the efficacy and safety in advanced BTC patients. So we plan this study to evaluate the efficacy and safety of FOLFIRI regimen as a second line treatment in biliary tract cancer.

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Fluorouracil	5FU 400mg/m2 bolus and then 2400mg/m2, continuous infusion D1-2
DRUG	Irinotecan Hydrochloride	Irinotecan 180 mg/m2
DRUG	leucovorin calcium	Leucovorin 200 mg/m2

Timeline

• Start date: 2019-09-06
• Primary completion: 2019-09-06
• Completion: 2019-09-06
• First posted: 2017-04-12
• Last updated: 2022-06-15

Locations

1 site across 1 country: South Korea