Safety and Efficacy of an Arginine-Restricted Diet in Patients With Solid Tumors

Inclusion criteria

• Sign a written informed consent form before any study - related procedures are carried out.
• Males or females, aged 18 - 80 years old.
• Diagnosed with solid tumors by pathological tissue biopsy.
• According to the RECIST v1.1 (Response Evaluation Criteria in Solid Tumors Version 1.1) criteria, there is at least 1 measurable lesion (lesions previously treated with local therapies such as radiotherapy cannot be regarded as measurable lesions).
• ECOG (Eastern Cooperative Oncology Group Performance Status) score of 0 - 1.
• NRS - 2002 (Nutritional Risk Screening 2002) score < 3.
• BMI (Body Mass Index) ≥ 18.5 (can be adjusted appropriately according to the actual situation).
• Patients who can eat orally or through a feeding tube and can tolerate enteral nutrition.
• Sufficient organ function, and the subjects need to meet the following laboratory indicators:

In the absence of granulocyte - colony - stimulating factor use in the past 14 days, the absolute neutrophil count ≥ 1.5×10⁹/L.

Platelets ≥ 75×10⁹/L. In the absence of blood transfusion or erythropoietin use in the past 7 days, hemoglobin ≥ 8 g/dL.

Serum albumin ≥ 3.0 g/dL. Total bilirubin ≤ 1.5× the upper limit of normal (ULN). Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5×ULN. In case of liver metastasis, ALT and/or AST ≤ 5×ULN, and total bilirubin ≤ 3×ULN. In case of liver or bone metastasis, Alkaline Phosphatase (AKP) ≤ 5×ULN.

Creatinine clearance rate ≥ 50 mL/min (calculated according to the Cockcroft - Gault formula) or serum creatinine ≤ 1.5×ULN.

International Normalized Ratio (INR) ≤ 1.5×ULN, Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN.

Urine protein < 2+ (if urine protein ≥ 2+, a 24 - hour urine protein quantification can be performed, and subjects with a 24 - hour urine protein quantification < 2.0 g can be enrolled).

• Women of child - bearing potential must agree to avoid sexual intercourse (heterosexual intercourse) or use a reliable and effective contraceptive method from the signing of the informed consent form until at least 6 months after the last administration of the study drug. In addition, the serum HCG (Human Chorionic Gonadotropin) test must be negative within 3 days before the start of the study treatment, and the subject must be non - lactating. A female patient is considered to be of child - bearing potential if she is post - menopausal but has not reached the post - menopausal state (non - menstrual period ≥ 12 consecutive months, and no other causes are found except menopause) and has not undergone sterilization surgery (such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).
• If there is a risk of pregnancy, all subjects (regardless of male or female) need to use a contraceptive method with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of the chemotherapy drug).

Exclusion criteria

• Patients with cognitive impairment or mental illness who are unable to understand the study content.
• Patients with central nervous system or meningeal metastases.
• Patients with clinically symptomatic moderate or severe ascites (that is, those who require therapeutic paracentesis within 2 weeks before the start of study treatment; patients with only a small amount of ascites shown on imaging and no clinical symptoms can be enrolled).
• Patients with uncontrolled or moderate to severe pleural effusion and pericardial effusion.
• Patients with severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralytic and mechanical intestinal obstruction; tracheoesophageal fistula, gastrointestinal perforation or gastrointestinal fistula, or abdominal abscess; patients with extra - gastrointestinal bleeding with a CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or above within 6 months before the start of study treatment or grade 2 or above within 3 months (such as abnormal vaginal bleeding, hematemesis).
• Patients known to be allergic to the active ingredients or excipients of the study drug.
• Patients with poorly controlled diabetes.
• Patients with poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg under routine antihypertensive treatment), with a history of hypertensive crisis or hypertensive encephalopathy.
• Patients with severe cardiovascular and cerebrovascular diseases, including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, and major vascular diseases within 6 months before enrollment (including but not limited to aortic aneurysms requiring surgical repair or recent arterial thrombosis); patients with poorly controlled clinical symptoms or heart diseases, such as unstable angina pectoris, NYHA (New York Heart Association) heart failure grade II or above, left ventricular ejection fraction < 50% on color Doppler echocardiography, or severe arrhythmias that cannot be controlled by drug treatment.
• Pregnant or lactating women.
• Other situations considered by the investigator as inappropriate for enrollment.