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

China Medical University, China1 site in 1 country30 target enrollmentAugust 1, 2022

ConditionsUnresectable or Metastatic Colorectal Cancer

InterventionsFOLFOX/FOLFIRI

DrugsFOLFOX/FOLFIRI

Overview

Phase: Phase 2
Intervention: FOLFOX/FOLFIRI
Conditions: Unresectable or Metastatic Colorectal Cancer
Sponsor: China Medical University, China
Enrollment: 30
Locations: 1
Primary Endpoint: Objective response rate (ORR)
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

August 1, 2022

End Date

December 1, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

China Medical University, China

Responsible Party

Principal Investigator

Jingdong Zhang

Chief physician

China Medical University, China

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;