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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Enrolling; Phase 2

Conditions: Advanced Colorectal Cancer

Treatments: Drug: mFOLFOX/FOLFIRI ( Standard Chemotherapy)

Study type: Interventional

Funder types: Other

Identifiers

NCT07391618

HL-ZY-058

Details and patient eligibility

About

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

Full 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

Enrollment: 583 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

583 participants in 2 patient groups

arm1

Experimental group

Description:

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

Treatment:

Drug: mFOLFOX/FOLFIRI ( Standard Chemotherapy)

arm2

Experimental group

Description:

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

Treatment:

Drug: mFOLFOX/FOLFIRI ( Standard Chemotherapy)