Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma — MOCHA  

Cholangiocarcinoma Clinical Trial

Official title: A Multi-Centre, Open-Label Phase 2 Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma (The MOCHA Trial)

Status Terminated

Clinical Trial Summary

This is a multi-centre, open-label, single arm phase 2 study to assess the efficacy of TRIFLURIDINE/TIPIRACIL, in patients with advanced cholangiocarcinoma as measured by median progression-free survival (PFS).

This study will enroll a total of 47 patients over a 12-month period, according to a two stage enrollment design. Nine patients will be enrolled during the first stage and the trial will be terminated if 4 or more out of the 9 have disease progression. If the trial goes on to the second stage, a total of 47 patients (38 in second stage) will be required.

Patients will be seen prior to enrolment (within 28 days of treatment), every 4 weeks while on treatment, at the end of treatment, and 30 days post-treatment. Patients will remain on long-term follow-up and will be seen every 12 weeks (+/- 14 days) until 1 year post-treatment when they will enter into the survival follow-up period and will be contacted every 12 weeks by phone until progression or toxicity.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Bile Duct Cancer
• Bile Duct Neoplasms
• Cholangiocarcinoma

• NCT number: NCT04076761
• Study type: Interventional
• Source: Sunnybrook Health Sciences Centre
• Status: Terminated
• Phase: Phase 2
• Start date: December 11, 2019
• Completion date: September 30, 2022