colorectal cancer
Conditions
Interventions
Second line treatment with 5-FU/levofloxacin regimen (Simultaneous infusion of levofloxacin and 5-FU):None
Sponsors
Affiliated Hospital OF Jiangnan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. No gender limit, age 18-75 years old; 2. Diagnosed as colorectal cancer by pathological histology and unable to undergo surgical resection; 3. For patients who have failed first-line treatment, the definition of treatment failure is: intolerable disease progression or toxic side effects during or after receiving first-line systemic chemotherapy treatment; For neoadjuvant/adjuvant therapy (chemotherapy or radiochemotherapy), if disease progression occurs during treatment or within 6 months after discontinuation of treatment, it should be considered as first-line treatment failure; 4. According to RECIST 1.1 standard, there should be at least one measurable lesion; 5. ECOGPS score: 0-2 points; 6. Expected survival period greater than 3 months; 7. The main organs are functioning normally, and there are no patients with severe abnormalities in blood, heart, lung, liver, kidney, bone marrow, etc. The laboratory examination meets the following requirements: (1) Hemoglobin (Hb) = 90g/L; (2) White blood cells (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) levels = 2.5 times the upper limit of normal (ULN); Renal function (serum creatinine sCr) level = 1.5 times the upper limit of normal value (ULN); (5) Total bilirubin (TBIL) = 1.5 times the upper limit of normal value (ULN). 8. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up; Researchers believe that treatment can benefit.
Exclusion criteria
Exclusion criteria: 1. Individuals who have been confirmed to be allergic to the investigational drug and/or its excipients; 2. Subjects who have received or are currently receiving additional chemotherapy, radiation therapy, targeted or immunotherapy; 3. Pregnant or lactating women; 4. Patients deemed unsuitable for inclusion in this study by the researchers; 5. Patients with internal medicine systemic diseases and psychiatric disorders who are not suitable for chemotherapy; 6. Patients who have participated in clinical trials of other drugs within four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective relief rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression free survival; | — |
Countries
China
Contacts
Public ContactWangTeng
Affiliated Hospital OF Jiangnan University
Outcome results
None listed