Back to resultsFOLFOX/FOLFIRI Containing Levofolinic Acid (Zuoyu ®) in the Treatment of Unresectable or Metastatic Colorectal Cancer
Primary Purpose
Unresectable or Metastatic Colorectal Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
FOLFOX/FOLFIRI
Sponsored by
About this trial
This is an interventional treatment trial for Unresectable or Metastatic Colorectal Cancer
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;
Sites / Locations
- Liaoning Cancer Hospital & InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FOLFOX/FOLFIRI
Arm Description
q2w, after 8 cycles of medication or patient intolerance or disease progression;
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Progression-free survival (PFS)
The date from random to the first occurrence of disease progression or death from any cause, whichever comes first
Disease control rate (DCR)
The proportion of patients whose BOR is CR, PR, and stable disease (SD) assessed
Full Information
NCT ID
NCT05797883
First Posted
March 22, 2023
Last Updated
March 22, 2023
Sponsor
China Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT05797883
Brief Title
FOLFOX/FOLFIRI Containing Levofolinic Acid (Zuoyu ®) in the Treatment of Unresectable or Metastatic Colorectal Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable or Metastatic Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FOLFOX/FOLFIRI
Arm Type
Experimental
Arm Description
q2w, after 8 cycles of medication or patient intolerance or disease progression;
Intervention Type
Drug
Intervention Name(s)
FOLFOX/FOLFIRI
Intervention 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.
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
The proportion of patients whose best overall response (BOR) is complete response (CR) or partial response (PR) assessed by iRECIST v1.1
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
The date from random to the first occurrence of disease progression or death from any cause, whichever comes first
Time Frame
2years
Title
Disease control rate (DCR)
Description
The proportion of patients whose BOR is CR, PR, and stable disease (SD) assessed
Time Frame
2years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingdong Zhang
Phone
+86-13804027878
Email
zhangjingdong@cancerhosp-ln-cmu.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qian Dong
Email
dongqian08@163.com
Facility Information:
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qian Dong, Doctor
Phone
17309815028
Email
dongqian08@163.com
First Name & Middle Initial & Last Name & Degree
Jingdong Zhang, Doctor
12. IPD Sharing Statement
Learn more about this trial
FOLFOX/FOLFIRI Containing Levofolinic Acid (Zuoyu ®) in the Treatment of Unresectable or Metastatic Colorectal Cancer
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