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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chinese PLA General Hospital, Beijing
  Beijing, China Recruiting

Study contacts

• Study coordinator: Guanghai Dai
• Email: daigh301@vip.sina.com
• Phone: +861066947252

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.