NCT04683965

Pemetrexed and TAS-102 in Combination With Bevacizumab in Refractory Colorectal Cancer

A Single Arm, Open Label, Exploratory Study of Pemetrexed and TAS-102 in Combination With Bevacizumab in Patients Who Have Progressed After Standard Second Line Therapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Limited agents are optional after standard first and second line treatment for mCRC. Only Regorafenib and Fruquintinib are approved in China. PFS of these targeted drugs are not very long. Pemetrexed has shown significant efficacy in advanced lung cancer regarding PFS and OS with controllable toxicity. TAS-102 has been used in colorectal cancer with promising outcomes. Bevacizumab is also an important monoclonal antibody which could make benefits in treated patients. This study is aimed to explore the efficacy, safety in advanced colorectal cancer failed to standard therapy in Chinese population.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
DRUG	Pemetrexed	Pemetrexed 500 mg/m2 d1
DRUG	TAS-102	TAS-102, capsule, 35mg/m2, bid,p.o, d1\~5,d8\~12
DRUG	Bevacizumab	Bevacizumab 5 mg/kg d1,d14

Timeline

• Start date: 2021-01-01
• Primary completion: 2024-01-01
• Completion: 2024-05-01
• First posted: 2020-12-24
• Last updated: 2022-08-02

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study