Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma

Official Title

A Multi-Centre, Open-Label Phase 2 Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma (The MOCHA 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.

Trial Description

Primary Outcome:

• Median progression-free survival (PFS)

• Safety and tolerability of FTD/TPI: CTCAE version 5.0
• Disease Control Rate (Complete Response, Partial Response, Stable Disease) of FTD/TPI
• Duration of response of FTD/TPI
• Median overall survival of patients with cholangiocarcinoma treated with FTD/TPI.
• Quality of life: European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30

View this trial on ClinicalTrials.gov