Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma
Status:
Recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
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.