Advanced colorectal cancer
Conditions
Interventions
Experimental group:Glutamine combined with XELOX + Bevacizumab
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 18 years or older, and 1.5 × 10^9/L in blood tests, hemoglobin > 8 g/dL and platelets > 100 × 10^9/L (based on the normal values of the clinical trial center); 7. Prothrombin time (PT) 50 ml/min); 9. When there is no liver metastasis, ALT or AST < 2.5 times the upper limit of the normal reference range, and serum total bilirubin < 1.5 times the upper limit of the normal reference range; for patients with liver metastasis, ALT or AST < 5 times the upper limit of the normal reference range, and serum total bilirubin < 3 times the upper limit of the normal reference range; 10. Pregnant women of childbearing age must be willing to take adequate contraceptive measures during the treatment with the study drug; 11. Have signed the informed consent form; 12. According to the definition of RECIST 1.1, the investigator determines that the patient has measurable disease. Tumor lesions located in the area of previous radiotherapy if confirmed to have progressed, are considered measurable.
Exclusion criteria
Exclusion criteria: 1. Within the past 2 years, there has been an active autoimmune disease requiring systemic treatment (i.e., the use of disease-modifying drugs, corticosteroids, or immunosuppressants). Alternative therapies (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are not considered systemic treatment; 2. Diagnosed with immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first administration of the trial treatment. After consulting the sponsor, the use of physiological doses of corticosteroids may be approved; 3. Within 4 weeks before the first day of the study, received anti-tumor monoclonal antibodies (mAb), or the adverse events caused by the drugs received 4 weeks ago have not recovered (i.e., <=1 grade or reaching baseline level); 4. Within 2 weeks before the first day of the study, received chemotherapy, targeted small molecule therapy, or radiotherapy, or the adverse events caused by the drugs received previously have not recovered (i.e., <=1 grade or reaching baseline level). Note: Subjects with <=2 grades of neuropathy or <=2 grades of alopecia are exceptions to this standard and may have the eligibility to participate in the study. a. If the subject has undergone major surgery, they must fully recover from the toxicity and/or complications caused by the intervention measures before starting the treatment; 5. Known to have other malignant tumors that are progressing or requiring active treatment. Excluding skin basal cell carcinoma, skin squamous cell carcinoma, or cervical carcinoma in situ that have received radical treatment; 6. Known to have active central nervous system (CNS) metastasis and/or cancerous meningitis. Subjects who have received treatment for brain metastases can also participate in this study, provided that the condition is stable (no disease progression determined by imaging examination within at least 1 week before the first administration of the trial treatment, and all neurological symptoms have returned to baseline level), there is no evidence of new or expanded brain metastasis, and steroid treatment has been stopped at least 7 days before the first administration of the trial treatment. This exception does not include cancerous meningitis, regardless of whether the clinical condition is stable or not, it should be excluded. Subjects with a history of steroid treatment for pneumonia (non-infectious) or currently suffering from pneumonia (non-infectious); 7. Active infections requiring systemic treatment; 8. History or disease evidence, treatment or abnormal laboratory values that may confuse the trial results, prevent the subject from fully participating in the study, or the investigator believes that participating in the study is not in the best interests of the subject; 9. Known to have possible mental or drug abuse disorders that may affect compliance with the trial requirements; 10. Female subjects who are pregnant or breastfeeding, or who plan to become pregnant during the planned study period or within 180 days after the last administration of the investigational treatment; or male subjects who intend to impregnate their partners during this period; 11. Known to have a history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies); 12. Known to have active hepatitis B or hepatitis C. Active hepatitis B is defined as a positive HBsAg result and a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival time, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Disease control rate, DCR;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactYing Yuan
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed