NCT05928312

Fruquintinib Combined With Chemotherapy as Third-line /Third-line+ Treatment in Advanced Colorectal Cancer

The Efficacy and Safety of Fruquintinib Combined With Chemotherapy as Third-line /Third-line+ Treatment in Advanced Colorectal Cancer: An Open， Single-center Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To explore the efficacy and safety of fruquintinib combined with chemotherapy as third-line/third-line+ Treatment in advanced metastatic colorectal cancer

Detailed description

Due to the limited efficacy of third-line treatment, the previously effective chemotherapy regimen is a new treatment mode. RE-OPEN, RE-OX and a Korean study confirmed that mCRC patients who had previously been effectively treated with oxaliplatin were retreated with oxaliplatin on the third line to help them achieve OS for 14.5 to 18.5 months. At the same time, a phase III randomized SUNLIGHT study showed good efficacy at the ASCO-GI Congress in 2023. The above studies show that the regimen of antivascular drugs combined with chemotherapy has a tendency to improve the survival of patients with third-line advanced colorectal cancer. In order to further improve the efficacy of fruquintinib, we conducted a clinical study of fruquintinib combined with chemotherapy to observe the efficacy and safety of Third-line/Third-line+ treatment of advanced colorectal cancer, and to provide a more effective treatment plan for third-line and above treatment for advanced colorectal cancer patients.

Conditions

• Advanced Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Fruquintinib Combined With Chemotherapy	1.Security introduction period: \[1\] Safety introduction period (N=6), fruquintinib combined with three-week regimen: 1\. Fruquintinib: Three-week regimen of combined chemotherapy: 4mg/d, orally, once a day, taking the drug for 2 weeks and stopping the drug for 1 week, 3 weeks as a treatment cycle. \[2\] Safety introduction period (N=6), fruquintinib combined 2-week regimen: 1. Fruquintinib: two-week combination chemotherapy regimen: 4mg/d, orally, once a day, taking the drug for 3 weeks and stopping the drug for 1 week, 4 weeks as a treatment cycle. 2. Dose expansion phase design(N=60) Cohort 1 (30 patients) : Fruquintinib combined with oxaliplatin. Cohort 2 (30 patients) : Fruquintinib combined with irinotecan .

Timeline

• Start date: 2023-08-28
• Primary completion: 2025-06-28
• Completion: 2026-06-01
• First posted: 2023-07-03
• Last updated: 2023-07-20

Locations

1 site across 1 country: China