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Clinical trial

Clinical Study on the Efficacy and Safety of FOLFOX/FOLFIRI± Targeted Drug Regimen Containing Levofolinic Acid (Zuoyu ®) in the Treatment of Unresectable or Metastatic Colorectal Cancer

ID
Name
HL-ZY-002
Description
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
Trial arms
Trial start
2022-08-01
Estimated PCD
2023-12-01
Trial end
2024-12-01
Status
Recruiting
Phase
Early phase I
Treatment
FOLFOX/FOLFIRI
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.
Arms:
FOLFOX/FOLFIRI
Size
30
Primary endpoint
Objective response rate (ORR)
2 years
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;
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2023-04-04

1 organization

1 product

1 indication

Organization
China Medical University
Product
FOLFOX/FOLFIRI
Indication
Colorectal Cancer