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

NCT04072445 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-08-09

Study results available
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Summary

This phase II trial studies how well trifluridine/tipiracil and irinotecan work in treating patients with biliary tract cancer that has spread to other places in the body (advanced) and has not responded to treatment (refractory). Trifluridine/tipiracil and irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

  • 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

Given IV

DRUG

Irinotecan Hydrochloride

Given IV

DRUG

Trifluridine and Tipiracil Hydrochloride

Given PO

Sponsors & Collaborators

Principal Investigators

  • Amit Mahipal · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-18
Primary Completion
2021-08-13
Completion
2021-08-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04072445 on ClinicalTrials.gov