An observational study in Biliary Tract Cancer and Biliary Tract Cancers (BTC), sponsored by Ankara University. Active, not recruiting at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Ankara University · Observational
The goal of this observational study is to compare chemotherapy types that are given after surgery for biliary tract cancers. The main question it aims to answer is:
Are any of the chemotherapy regimens more effective in preventing recurrence, providing longer survival, or having less toxicity?
Nationwide multicenter retrospective data will be collected.
484 studies on the registry are indexed under Biliary Tract Neoplasms; 187 are open to participants now.
This study's planned enrollment of 600 is above the median of 160 across 67 observational studies indexed under Biliary Tract Neoplasms.
Browse Biliary Tract Neoplasms studies →Ankara University is the lead sponsor of 312 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients treated in any hospital (public, private, university/academic) across Türkiye
Exclusion Criteria:
Patients with biliary tract cancer, who underwent resection and received adjuvant chemotherapy
Drug: Chemotherapy
Any chemotherapy regimen that is used in the adjuvant setting
Also known as: capecitabine, gemcitabine, gemcitabine-cisplatin, gemcitabine-capecitabine, gemcitabine-oxaliplatin
Recurrence-free survival
The length of time from the start of adjuvant chemotherapy to the date of the first loco-regional or systemic recurrence or death
Time frame: From the date of adjuvant chemotherapy initiation until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 180 months
Overall survival
The length of time from the start of adjuvant chemotherapy to the date of death
Time frame: From the date of adjuvant chemotherapy initiation until the date of death from any cause, assessed up to 180 months
2-year recurrence-free survival
The length of time from the start of adjuvant chemotherapy to the date of recurrence or date in the first 2-years
Time frame: From start of adjuvant chemotherapy to the date of recurrence or death in the first 2 years
2-year overall survival
The length of time from the start of adjuvant chemotherapy to the date of death in the first 2 years
Time frame: From start of adjuvant chemotherapy to the date of death in the first 2 years
The number of patients experienced toxicities
The rates of grade 1-2 and grade 3-4 toxicities, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: From the date of initiation of the first cycle of adjuvant chemotherapy until 1 month after the last cycle of adjuvant chemotherapy
Recurrence-free survival analyses in subgroups
Recurrence-free survival (The length of time from start of adjuvant chemotherapy to the date of the first loco-regional or systemic recurrence or death) will be analysed and compared in different subgroups. Subgroups * Age ( below 65 vs. 65 and above 65) * ECOG performance score (0 vs. 1) * Lymph node status (Positive vs negative) * Resection (R1 vs. R0) * Anatomical subtype (intrahepatic vs perihilar vs. distal vs gallbladder)
Time frame: From the date of adjuvant chemotherapy initiation until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 180 months
Overall survival analyses in subgroups
Overall survival (The length of time from the start of adjuvant chemotherapy to the date of death) will be analysed and compared in different subgroups. Subgroups * Age ( below 65 vs. 65 and above 65) * ECOG performance score (0 vs. 1) * Lymph node status (Positive vs negative) * Resection (R1 vs. R0) * Anatomical subtype (intrahepatic vs perihilar vs. distal vs gallbladder)
Time frame: From the date of adjuvant chemotherapy initiation until the date of death from any cause, assessed up to 180 months
Plan to share: No
This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Ankara University