NCT05035914

Anlotinib Combined With mXELIRI as Second-line Treatment of Advanced Colorectal Cancer

Phase Ib / II Study of Anlotinib Combined With mXELIRI as Second-line Treatment of Advanced Colorectal Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Guangzhou University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed 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).

Conditions

• Advanced Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Anlotinib Hydrochloride	Anlotinib Hydrochloride is a capsule in the form of 8 mg ,10 mg and 12 mg, orally, once daily, 2 weeks on/1 week off.

Timeline

• Start date: 2021-07-09
• Primary completion: 2022-12-31
• Completion: 2024-12-31
• First posted: 2021-09-05
• Last updated: 2021-09-05

Locations

1 site across 1 country: China