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

NCT07391618 | Recruiting Phase 2

• 1 other identifier: HL-ZY-058
• Study Type: interventional
• Target: 583
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Colorectal Cancer

Keywords

levozolinate

Outcome Measures

Primary Outcomes (1)

• PFS

  up to 3 years

Secondary Outcomes (5)

• ORR

  up to 3 years

• DCR

  up to 3 years

• DoR

  up to 3 years

• OS

  up to 3 years

• Adverse Event

  Thirty days after the last treatment

Study Arms (2)

arm1

EXPERIMENTAL

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)

arm2

EXPERIMENTAL

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)

Interventions

mFOLFOX/FOLFIRI ( Standard Chemotherapy) DRUG

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.

arm1; arm2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects voluntarily joined this study and signed the informed consent form.
• Age: 18 to 75 years old, gender not limited;
• ECOG PS score: 0-2 points
• 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;
• No previous treatment for unresectable or metastatic lesions has been received;
• There is at least one measurable lesion in accordance with the RECIST 1.1 standard;
• 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.
• Hemoglobin (Hb) ≥70 g/L;
• White blood cell count (WBC) ≥3.0×109/L; Neutrophil count (NEUT) ≥1.5×109/L;
• Platelet count (PLT) ≥100×109/L;
• 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).
• The expected survival period is more than three months.

You may not qualify if:

• Those who have been confirmed to be allergic to the test drug and/or its excipients;
• Those with contraindications to chemotherapy;
• Colorectal cancer patients with MSI-H or dMMR;
• Pregnant or lactating women;
• There is a history of other malignant tumors in the past;
• Those with systemic internal diseases and mental disorders who are not suitable for chemotherapy;

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital, Beijing

Beijing, China

RECRUITING

Study Officials

• Guanghai Dai

  Chinese PLA General Hospital

  STUDY CHAIR

Central Study Contacts

Guanghai Dai

CONTACT

+861066947252; daigh301@vip.sina.com

miaomiao Gou

CONTACT

daigh301@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 6, 2026
• Study Start: May 15, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 6, 2026

Record last verified: 2026-01

Locations

CN (1)