Study protocol of an open-label, single arm phase II trial investigating the efficacy and safety of Trifluridine/Tipiracil combined with irinotecan as a second line therapy in patients with cholangiocarcinoma (TRITICC)

Table 6 Recommended dose interruption/ modification criteria

	Grade 2	Grade 3	Grade 4
1st occurence	No dose recuction, prophylaxis if possible	75% of the initial dose, prophylaxis if possible	Permanent discontinuation, unless continuation of treatment is in the patients best interest; if so 50% of the inizial dose following consultation with the study coordination centre
2nd occurence	75% of the initial dose	50% of the initial dose
3rd occurence	50% of the initial dose	Definitive withdrawal, unless continuation of treatment is in the patients best interest
4th occurence	Permanent discontinuation, unless continuation of treatment is in the patients best interest

ISSN: 1471-2407