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Trial Title:
FOLFOX/FOLFIRI Containing Levofolinic Acid (Zuoyu ®) in the Treatment of Unresectable or Metastatic Colorectal Cancer
NCT ID:
NCT05797883
Condition:
Unresectable or Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
FOLFOX/FOLFIRI
Description:
mFOLFOX6 ：oxaliplatin 85mg/m² IV infusion 2h d1, 5-FU 400mg/m² push d1, Then 5-FU
1200mg/(m2▪d)×2d+Levofolinic Acid 200mg/m² continuous mixed infusion for 46-48h (total
5-FU 2400mg/m²); FOLFIRI ：Irinotecan 180mg/m ² static pulse infusion 30min~90min d1, 5-FU
400mg/m² push d1, Then 5-FU 1200mg/(m2▪d)×2d+ Levofolinic Acid 200mg/m² continuous mixed
infusion for 46-48h (total 5-FU 2400mg/m²); The combination of cetuximab/bevacizumab and
other targeted agents depends on the patient.
Arm group label:
FOLFOX/FOLFIRI
Summary:
To observe and evaluate the efficacy and safety of FOLFOX/FOLFIRI± target-directed
regimen containing Levofolinic Acid (Zuoyu ®) in first-line treatment of unresectable or
metastatic colorectal cancer
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male or female, ≥18 years old;
- Patients with histopathologically confirmed unresectable or metastatic colorectal
cancer who have not previously received chemotherapy or targeted therapy for
unresectable or metastatic lesions;
- Have at least one measurable lesion according to RECIST 1.1 standards;
- ECOG PS score: 0-2;
- Expected survival greater than 3 months;
- Routine blood routine, liver and kidney function, electrocardiogram and other
routine tests were basically normal, no contraindications of chemotherapy;
- The subjects voluntarily joined the study, signed the informed consent, had good
compliance, and cooperated with follow-up visits;
- Researchers believe treatment can benefit.
Exclusion Criteria:
- A proven allergy to the test drug and/or its excipients;
- Pregnant or lactating women;
- Patients judged by the investigator to be unsuitable for inclusion in this study;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Liaoning Cancer Hospital & Institute
Address:
City:
Shenyang
Zip:
110042
Country:
China
Status:
Recruiting
Contact:
Last name:
Qian Dong, Doctor
Phone:
17309815028
Email:
dongqian08@163.com
Investigator:
Last name:
Jingdong Zhang, Doctor
Email:
Principal Investigator
Start date:
August 1, 2022
Completion date:
December 1, 2024
Lead sponsor:
Agency:
China Medical University, China
Agency class:
Other
Source:
China Medical University, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05797883
