NCT03222089

Phase II Trial of FOLFOXIGIL Versus FOLFOXIRI as First-line Therapy in Patients With mCRC

FOLFOXIRI in Combination With GM-CSF and IL-2 (FOLFOXIGIL) Versus FOLFOXIRI as First-line Treatment for Patients With Metastatic Colorectal Cancer: a Phase II Trial by the FNF Team.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A randomized phase II trial of FOLFOXIRI in Combination With GM-CSF and IL-2 (FOLFOXIGIL) Versus FOLFOXIRI as First-line Treatment for Patients With Metastatic Colorectal Cancer.

Detailed description

The triple drug regimen FOLFOXIRI (irinotecan, oxaliplatin, fluorouracil, and folinate) for the first-line treatment of metastatic colorectal cancer has shown a significant increase in response rate and overall survival compared to FOLFIRI and FOLFOX. The combination of GOLF chemotherapy with GM-CSF and IL-2（GOLFIG regimen） has shown more active than the standard FOLFOX chemotherapy in first-line mCRC patients，through the chemoimmunomodulatory effects. SO the FOLFOXIGIL chemoimmunotherapy regimen was designed with the same principle to evaluate the antitumor frontline efficacy in comparison with the FOLFOXIRI regimen as first-line treatment of mCRC patients. This is a multicenter, randomized controlled, double-blind, phase II trial.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan	Irinotecan 165 mg/m² 1-hour IV day 1
DRUG	Oxaliplatin	oxaliplatin 85 mg/m² 2-hours IV day 1
DRUG	Levoleucovorin	Levoleucovorin 200 mg/m² 2-hours IV day 1
DRUG	5-FU	5-FU 2800 mg/m² 46-hours flat continuous infusion IV
DRUG	GM-CSF	GM-CSF 150ug s.c. d3-7 , Repeated every 4 weeks.
DRUG	IL-2	Interleukin-2 100MIU s.c. d8-14 and d17-d28, Repeated every 4 weeks.

Timeline

• Start date: 2017-07-20
• Primary completion: 2019-07-20
• Completion: 2020-07-20
• First posted: 2017-07-19
• Last updated: 2018-03-27

Locations

1 site across 1 country: China