FOLFOX/FOLFIRI Containing Levofolinic Acid (Zuoyu ®) in the Treatment of Unresectable or Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Unresectable or Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: FOLFOX/FOLFIRI


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FOLFOX/FOLFIRI<br>q2w, after 8 cycles of medication or patient intolerance or disease progression; | Drug: FOLFOX/FOLFIRI<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | The proportion of patients whose best overall response (BOR) is complete response (CR) or partial response (PR) assessed by iRECIST v1.1 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | The date from random to the first occurrence of disease progression or death from any cause, whichever comes first | 2years | 
| Disease control rate (DCR) | The proportion of patients whose BOR is CR, PR, and stable disease (SD) assessed | 2years |