Determine the maximum tolerable dose (MTD) and / or phase II recommended dose (RP2D) of
the allotinib combined mXELIRI protocol.
To evaluate the safety and tolerance of the combination of anlotinib and mXELIRI in the
second-line treatment of patients with advanced colorectal cancer
This study consists of two phases, the dose-escalation phase, and the expansion phase. 9-12
patients with advanced colorectal cancer will be included in the dose escalation study.
Patients who met the inclusion criteria would be treated with anlotinib QD for 2 weeks, and
then stopped for 1 week, combined with mXELIRI. Every 21 days was a treatment cycle. Safety
information was collected until the disease progression or intolerable toxicity, so as to
determine the MTD and / or RP2D of anlotinib combined with irinotecan in patients with
advanced colorectal cancer. The study adopted the traditional 3+3 design .
The primary outcome in dose-expansion phase was objective response rate(ORR).
Advanced Colorectal Cancer
Clinical Study Identifier
Guangzhou University of Traditional Chinese Medicine
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