๐ฌIn plain words
What the trial is, and whether it could suit you
Phase II study of simultaneous infusion of levozolinate for injection and 5-FU as first-line treatment for advanced colorectal cancer
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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) โฅ70 g/L;
2. White blood cell count (WBC) โฅ3.0ร109/L; Neutrophil count (NEUT) โฅ1.5ร109/L;
3. Platelet count (PLT) โฅ100ร109/L;
4. Liver function (aspartate aminotransferase AST or alanine aminotransferase ALT) level โค2.5 times the upper limit of normal value (ULN); Renal function (serum creatinine sCr) level โค1.5 times the upper limit of the normal value (ULN). Total bilirubin (TBIL) โค1.5 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.
๐
What it tests
- mFOLFOX/FOLFIRI ( Standard Chemotherapy)
Chinese PLA General Hospital, Beijing
Beijing, China
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.