Overview

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

Status:
Not yet recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
Summary
FOLFIRI as a salvage treatment in metastatic biliary tract cancer (BTC) patients who failed gemcitabine containing chemotherapy
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Samsung Medical Center
Treatments:
Calcium
Fluorouracil
Irinotecan
Leucovorin
Levoleucovorin
Criteria
Inclusion Criteria:

Provision of a signed written informed consent Age ≥ 20 Histologically or cytologically
confirmed carcinoma of biliary tract Progression after treatment with first line
gemcitabine-based chemotherapy ECOG performance status of 0~2 Measurable lesion per RECIST
1.1 criteria Expected life expectancy ≥ 3months Adequate marrow, hepatic, renal and cardiac
functions Negative pregnancy test within 28 days Available archival tissue or fresh biopsy

Exclusion Criteria:

Poor performance statue Previous treatment history of irinotecan Hypersensitivity to
irinotecan Other primary cancer except properly treated non-melanoma skin cancer, cured
cervix carcinoma in situ and other cured solid tumor without evidence of recurrence after 5
years of curative treatment.

Severe co-morbid illness and/or active infections Any other clinical trial therapeutics
within 14 days Any anti-cancer therapy within 3 weeks prior to initiation of study
treatment (radiotherapy, systemic chemotherapy) CTCAE grade 2 or more adverse events
remained Intestinal obstruction or CTCAE grade 3-4 upper GI bleeding within 4 weeks QTcB >
480msec or family history of QT prolongation Current heart problem such as: pooly
controlled hypertension cardiomyopathy, clinically significant valvular heart disease,
uncontrolled angina, acute coronary syndrome within 6 months.

Severe, uncontrolled systemic disease, active infection such as HBV, HCV or HIV, active
bleeding tendency or history of organ transplantation