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

Official title

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

Overview

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

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

Interventions

• 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 s

Primary outcome measures

• PFS [Time frame: up to 3 years]

Secondary outcome measures (5)

• ORR [Time frame: up to 3 years]
• DCR [Time frame: up to 3 years]
• DoR [Time frame: up to 3 years]
• OS [Time frame: up to 3 years]
• Adverse Event [Time frame: Thirty days after the last treatment]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• Patients who were determined by the researchers to be unsuitable for inclusion in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Chinese PLA General Hospital, Beijing — Beijing

Identifiers

NCT: NCT07391618 · HL-ZY-058

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗