# Trifluridine/Tipiracil and Irinotecan for the Treatment of Advanced Refractory Biliary Tract Cancer

> **NCT04072445** · PHASE2 · COMPLETED · sponsor: **Mayo Clinic** · enrollment: 28 (actual)

## Conditions studied

- Advanced Bile Duct Carcinoma
- Advanced Gallbladder Carcinoma
- Refractory Bile Duct Carcinoma
- Refractory Gallbladder Carcinoma
- Stage III Distal Bile Duct Cancer AJCC v8
- Stage III Gallbladder Cancer AJCC v8
- Stage III Intrahepatic Bile Duct Cancer AJCC v8
- Stage IIIA Distal Bile Duct Cancer AJCC v8
- Stage IIIA Gallbladder Cancer AJCC v8
- Stage IIIA Intrahepatic Bile Duct Cancer AJCC v8
- Stage IIIB Distal Bile Duct Cancer AJCC v8
- Stage IIIB Gallbladder Cancer AJCC v8
- Stage IIIB Intrahepatic Bile Duct Cancer AJCC v8
- Stage IV Distal Bile Duct Cancer AJCC v8
- Stage IV Gallbladder Cancer AJCC v8
- Stage IV Intrahepatic Bile Duct Cancer AJCC v8
- Stage IVA Gallbladder Cancer AJCC v8
- Stage IVB Gallbladder Cancer AJCC v8

## Interventions

- **DRUG:** Irinotecan
- **DRUG:** Irinotecan Hydrochloride
- **DRUG:** Trifluridine and Tipiracil Hydrochloride

## Key facts

- **NCT ID:** NCT04072445
- **Lead sponsor:** Mayo Clinic
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2019-10-18
- **Primary completion:** 2021-08-13
- **Final completion:** 2021-08-13
- **Target enrollment:** 28 (ACTUAL)
- **Last updated:** 2023-08-09

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04072445

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04072445, "Trifluridine/Tipiracil and Irinotecan for the Treatment of Advanced Refractory Biliary Tract Cancer". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT04072445. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
