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

NCT05797883 | Unknown Phase 2

• 1 other identifier: HL-ZY-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Unresectable or Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Progression-free survival (PFS)

  2years

• Disease control rate (DCR)

  2years

Study Arms (1)

FOLFOX/FOLFIRI

EXPERIMENTAL

q2w, after 8 cycles of medication or patient intolerance or disease progression;

Drug: FOLFOX/FOLFIRI

Interventions

FOLFOX/FOLFIRI DRUG

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.

FOLFOX/FOLFIRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• A proven allergy to the test drug and/or its excipients;
• Pregnant or lactating women;

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110042, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Folfox protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Jingdong Zhang

CONTACT

+86-13804027878; zhangjingdong@cancerhosp-ln-cmu.com

Qian Dong

CONTACT

dongqian08@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 4, 2023
• Study Start: August 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: April 4, 2023

Record last verified: 2023-01

Locations

CN (1)