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Clinical Trial Summary

1. Determine the maximum tolerable dose (MTD) and / or phase II recommended dose (RP2D) of the allotinib combined mXELIRI protocol. 2. To evaluate the safety and tolerance of the combination of anlotinib and mXELIRI in the second-line treatment of patients with advanced colorectal cancer


Clinical Trial Description

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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05035914
Study type Interventional
Source Guangzhou University of Traditional Chinese Medicine
Contact Haibo Zhang, Professor
Phone 86 20 81887233
Email [email protected]
Status Recruiting
Phase Phase 1/Phase 2
Start date July 9, 2021
Completion date December 31, 2024

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