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

NCT03222089 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-03-27

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Fujian Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Rongbo Lin, MD · Fujian Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-20
Primary Completion
2019-07-20
Completion
2020-07-20

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03222089 on ClinicalTrials.gov