Clinical Study on the First-line Treatment of Advanced Colorectal Cancer With Simultaneous Infusion of Levozolinate for Injection and 5-FU

A Study to Evaluate the Efficacy and Safety of a First-line Treatment for Advanced Colorectal Cancer With Simultaneous Infusion of Levozolinate for Injection and 5-FU

Phase II study of simultaneous infusion of levozolinate for injection and 5-FU as first-line treatment for advanced colorectal cancer

Study Overview

• Status: Recruiting
• Conditions: Advanced Colorectal Cancer
• Intervention / Treatment: Drug: mFOLFOX/FOLFIRI ( Standard Chemotherapy)

Detailed Description

To observe and evaluate the efficacy and safety of simultaneous infusion of levofolinate for injection and 5-FU in the first-line treatment of advanced colorectal cancer

• Study Type: Interventional
• Enrollment (Estimated): 583
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Guanghai Dai; Phone Number: +861066947252; Email: daigh301@vip.sina.com
• Study Contact Backup: Name: miaomiao Gou; Email: daigh301@vip.sina.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Chinese PLA General Hospital, Beijing
    • Contact: Guanghai Dai; Phone Number: +861066947252; Email: daigh301@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The subjects voluntarily joined this study and signed the informed consent form.
2. Age: 18 to 75 years old, gender not limited;
3. ECOG PS score: 0-2 points
4. Patients with unresectable or metastatic colorectal cancer confirmed by histology or cytology, where the primary tumor location and the status of RAS and BRAF are known;
5. No previous treatment for unresectable or metastatic lesions has been received;
6. There is at least one measurable lesion in accordance with the RECIST 1.1 standard;

7. In the pre-treatment examination indicators, there was no serious hematopoietic function abnormality, and the functions of the heart, lungs, liver and kidneys were basically normal.

   1. Hemoglobin (Hb) ≥70 g/L;
   2. White blood cell count (WBC) ≥3.0×109/L; Neutrophil count (NEUT) ≥1.5×109/L;
   3. Platelet count (PLT) ≥100×109/L;
   4. Liver function (aspartate aminotransferase AST or alanine aminotransferase ALT) level ≤2.5 times the upper limit of normal value (ULN); Renal function (serum creatinine sCr) level ≤1.5 times the upper limit of the normal value (ULN). Total bilirubin (TBIL) ≤1.5 times the upper limit of the normal value (ULN).
8. The expected survival period is more than three months.

Exclusion Criteria:

1. Those who have been confirmed to be allergic to the test drug and/or its excipients;
2. Those with contraindications to chemotherapy;
3. Colorectal cancer patients with MSI-H or dMMR;
4. Pregnant or lactating women;
5. There is a history of other malignant tumors in the past;
6. Those with systemic internal diseases and mental disorders who are not suitable for chemotherapy;
7. Patients who were determined by the researchers to be unsuitable for inclusion in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: arm1; For patients with wild-type RAS and BRAF and the primary lesion located in the left colorectum, the mFOLFOX6 or FOLFIRI regimens with simultaneous infusion of levofolinic acid and 5-FU for injection were received. Whether to combine cetuximab was determined by the researchers	Drug: mFOLFOX/FOLFIRI ( Standard Chemotherapy); mFOLFOX6: Oxaliplatin 85mg/m², intravenous infusion for 2 hours, day 1; 5-FU 400mg/m² injection, d1; Levofolic acid for injection at 200mg/m² and 5-FU at 2400mg/m² were mixed and infused simultaneously for 46 to 48 hours. Repeat every two weeks until disease progression or intolerable toxicity occurs. FOLFIRI: Irinotecan 180mg/m², intravenous infusion for 30 to 90 minutes on day 1; 5-FU 400mg/m² injection d1; Levofolic acid for injection at 200mg/m² and 5-FU at 2400mg/m² were mixed and infused simultaneously for 46 to 48 hours. Repeat every two weeks until disease progression or intolerable toxicity occurs.
Experimental: arm2; For patients with both RAS and BRAF wild-type and with the primary lesion located in the right colorectal and/or RAS or BRAF mutant type, the mFOLFOX6 or FOLFIRI regimen with simultaneous infusion of levofolinic acid and 5-FU for injection, whether to combine bevacizumab, was determined by the researchers	Drug: mFOLFOX/FOLFIRI ( Standard Chemotherapy); mFOLFOX6: Oxaliplatin 85mg/m², intravenous infusion for 2 hours, day 1; 5-FU 400mg/m² injection, d1; Levofolic acid for injection at 200mg/m² and 5-FU at 2400mg/m² were mixed and infused simultaneously for 46 to 48 hours. Repeat every two weeks until disease progression or intolerable toxicity occurs. FOLFIRI: Irinotecan 180mg/m², intravenous infusion for 30 to 90 minutes on day 1; 5-FU 400mg/m² injection d1; Levofolic acid for injection at 200mg/m² and 5-FU at 2400mg/m² were mixed and infused simultaneously for 46 to 48 hours. Repeat every two weeks until disease progression or intolerable toxicity occurs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PFS	up to 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
OS	up to 3 years
ORR	up to 3 years
DCR	up to 3 years
DoR	up to 3 years
Adverse Event	Thirty days after the last treatment

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Study Chair: Guanghai Dai, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: levozolinate
• Other Study ID Numbers: HL-ZY-058

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No