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

Unresectable or Metastatic Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05797883
• Other study ID #: HL-ZY-002
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2023
• Source: China Medical University, China
• Contact: Jingdong Zhang
• Phone: +86-13804027878
• Email: zhangjingdong[@]cancerhosp-ln-cmu.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Unresectable or Metastatic Colorectal Cancer

Intervention

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.

Locations

Country	Name	City	State
China	Liaoning Cancer Hospital & Institute	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, China

Country where clinical trial is conducted

China, 

Outcome

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