First-line treatment of advanced colorectal cancer using simultaneous levofolinate and 5‑FU infusion

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

This trial will try combining simultaneous infusion of levofolinate (levozolinate) with 5‑FU as first-line chemotherapy for adults with unresectable or metastatic colorectal cancer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 583 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT07391618 on ClinicalTrials.gov

What this trial studies

This Phase II study gives adults with unresectable or metastatic colorectal cancer standard mFOLFOX or FOLFIRI chemotherapy using a simultaneous infusion of levofolinate and 5‑fluorouracil (5‑FU). The trial monitors tumor response by RECIST 1.1 and tracks safety with regular blood tests and organ-function assessments. Eligible participants are treatment‑naïve for metastatic disease, have measurable lesions, known RAS/BRAF status, and adequate performance status and organ function. The study is conducted at the Chinese PLA General Hospital in Beijing and focuses on response rates and treatment tolerability.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically or cytologically confirmed unresectable or metastatic colorectal cancer, known RAS/BRAF status, at least one measurable lesion, ECOG 0–2, adequate blood counts and organ function, and no prior treatment for metastatic disease are ideal candidates.

Not a fit: Patients who have already received prior treatment for metastatic disease, have poor organ function or ECOG >2, are outside the 18–75 age range, or lack measurable disease are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the approach could improve how effectively and tolerably 5‑FU‑based first‑line chemotherapy controls advanced colorectal cancer.

How similar studies have performed: Combining folinate (leucovorin or levoleucovorin) with 5‑FU is a long‑established standard and levoleucovorin formulations have shown similar effectiveness in prior studies, but the specific simultaneous‑infusion formulation has been less widely tested.

Eligibility criteria

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.

Where this trial is running

Beijing

• Chinese PLA General Hospital, Beijing — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Guanghai Dai

Conditions: Advanced Colorectal Cancer, levozolinate