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

March 22, 2023 updated by: Jingdong Zhang, China Medical University, China

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110042
        • Recruiting
        • Liaoning cancer Hospital & Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

March 22, 2023

First Submitted That Met QC Criteria

March 22, 2023

First Posted (Actual)

April 4, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL-ZY-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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