Tumor
Conditions
Interventions
Experimental Group:Vitamin B6-restricted diet combined with immunotherapy
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Before implementing any trial-related procedures, sign a written informed consent. 2. Male or female, aged 18 to 80; 3. Pathological tissue biopsy diagnosed solid tumor; 4. Currently undergoing or about to receive immunotherapy; 5. According to the RECIST v1.1 (Response Evaluation Criteria in Solid Tumors Version 1.1) standard, there is at least one measurable lesion (lesions that have previously received local treatments such as radiotherapy cannot be regarded as measurable lesions); 6.ECOG (Eastern Cooperative Oncology Group Performance Status) score: 0-1 point; 7.NRS-2002 (Nutritional Risk Screening 2002) score = 18.5 (can be adjusted appropriately according to the actual situation); 9. Patients who can eat orally or through tubes can tolerate enteral nutrition. 10. Sufficient organ function. The subjects need to meet the following laboratory indicators: (1) Without the use of granulocyte colony-stimulating factor in the past 14 days, the absolute value of neutrophils is >=1.5×10^9/L; (2) Platelet count >=75×10^9/L; (3) In the past 7 days, without blood transfusion or the use of erythropoietin, the hemoglobin level is >=8g/dL. (4) Serum albumin = 3.0g/dL; (5) Total bilirubin =50 mL/min (calculated according to the Cockcroft-Gault formula) or serum creatinine =2+, 24-hour urine protein quantification can be conducted. Subjects with 24-hour urine protein quantification = 12 consecutive months, and no other causes other than menopause have been found), and have not undergone sterilization surgery (such as hysterectomy, bilateral tubal ligation or bilateral oophorectomy), are considered to have fertility. (11) If there is a risk of conception, all subjects (regardless of gender) must undergo the entire treatment period until the last study of the treatment Contraceptive measures with an annual failure rate of less than 1% should be adopted within 120 days after drug administration (or 180 days after the last chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: 1. Exclusion of patients currently taking medications that deplete vitamin B6 (such as isoniazid, cycloserine, hydroxyurea) or those on long-term high-dose vitamin B6 supplementation. 2.Patients with cognitive impairment or psychological disorders that preclude comprehension of the study requirements. 3.Minors unable to make independent medical decisions or patients incapable of providing written informed consent. 4.Patients with central nervous system or leptomeningeal metastases. 5. Patients with clinically significant moderate or severe ascites (i.e., requiring therapeutic paracentesis within 2 weeks prior to initiation of study treatment; patients with only radiologically evident minimal ascites without clinical symptoms may be enrolled). 6.Uncontrolled or moderate to severe pleural effusion and pericardial effusion. 7.Patients with severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralytic or mechanical intestinal obstruction; tracheoesophageal fistula, gastrointestinal perforation or fistula, or intra-abdominal abscess; patients with extra-digestive tract hemorrhage of CTCAE grade 3 or higher within 6 months prior to study treatment initiation, or CTCAE grade 2 or higher within 3 months (e.g., abnormal vaginal bleeding, hematemesis). 8.Any other condition that may affect study results or lead to premature study termination (as determined by the investigator), such as alcohol abuse, substance abuse, other severe comorbidities requiring combined treatment (including psychiatric disorders), peripheral neuropathy, anemia or skin lesions, familial or social factors, or any other circumstance that may compromise patient safety or data integrity. 9.Known allergy to the active pharmaceutical ingredient or excipients of the study drug. 10. Patients with poorly controlled diabetes mellitus. 11. Poorly controlled hypertension (systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg despite conventional antihypertensive therapy), or history of hypertensive crisis or hypertensive encephalopathy. 12.Patients with severe cardiovascular or cerebrovascular diseases, including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, or major vascular disease within 6 months prior to enrollment (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis); patients with uncontrolled clinical symptoms or cardiac diseases such as unstable angina, NYHA class II or higher heart failure, left ventricular ejection fraction <50% on echocardiography, or severe arrhythmia refractory to medical therapy. 13.Active tuberculosis infection based on medical history or CT imaging, or history of active tuberculosis within 1 year prior to enrollment, or active tuberculosis over 1 year prior to enrollment without standardized treatment. 14.Patients with active autoimmune diseases or history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism [subjects with hypothyroidism controlled only with hormone replacement therapy may be enrolled]); subjects with non-systemic skin diseases (e.g., vitiligo, psoriasis, alopecia), controlled type I diabetes managed with insulin, or asthma in complete remission since childhood without any intervention in adulthood may be enrolled (asthma requiring bronchodilator therapy is excluded).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment - Emergent Adverse Event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate, DCR;Duration of Response; | — |
Countries
China
Contacts
Public ContactXuelei Ma
West China Hospital
Outcome results
None listed