solid tumors
Conditions
Interventions
Test group:Arginine-restricted diet(-Arg diet)
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Sign a written informed consent before implementing any procedures related to the trial. (2) Male or female, aged between 18 and 75 years old. (3) Diagnosed with solid tumors by pathological tissue biopsy. (4) According to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria, there is at least 1 measurable lesion (lesions that have previously received local treatments such as radiotherapy cannot be regarded as measurable lesions). (5) Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0-1. (6) Nutritional Risk Screening 2002 (NRS-2002) score = 18.5 (which can be appropriately adjusted according to the actual situation). (8) Patients who can eat orally or through a nutritional tube and are able to tolerate enteral nutrition. (9) Sufficient organ function, and the subjects need to meet the following laboratory indicators: 1) Absolute neutrophil count >= 1.5×10?/L without the use of granulocyte colony-stimulating factor within the last 14 days. 2) Platelets >= 75×10?/L. 3) Hemoglobin >= 8 g/dL without blood transfusion or the use of erythropoietin within the last 7 days. 4) Serum albumin >= 3.0 g/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 performed, and subjects with a 24-hour urine protein quantification = 12 consecutive months and no other causes except menopause are found) and have not undergone sterilization surgery (such as hysterectomy, bilateral salpingectomy or bilateral oophorectomy) are considered to be of childbearing potential. (11) If there is a risk of pregnancy, all subjects (both male and female) are required to use a contraceptive measure 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
Exclusion criteria: (1) Patients with cognitive impairment or mental disorders who are unable to understand the content of the study. (2) Patients with metastases to the central nervous system or meninges. (3) Patients with moderate or severe ascites accompanied by clinical symptoms (that is, those who require therapeutic puncture and drainage within 2 weeks before the start of the study treatment. Patients who only show a small amount of ascites on imaging and have no clinical symptoms can be enrolled). (4) Uncontrolled, moderate or severe pleural effusion and pericardial effusion. (5) Patients with severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralytic or mechanical intestinal obstruction; patients with tracheoesophageal fistula, gastrointestinal perforation or gastrointestinal fistula, or intra-abdominal abscess; patients with extra-gastrointestinal bleeding who have a CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or above within 6 months before the start of the study treatment or a CTCAE grade 2 or above within 3 months (such as abnormal vaginal bleeding, hematemesis). (6) Other factors of the subjects that may affect the study results or lead to the forced termination of the study (as judged by the researchers), such as alcohol abuse, drug abuse, other serious diseases requiring combined treatment (including mental diseases), severely abnormal laboratory test values, family or social factors, and other situations that may affect the safety of the subjects or the collection of study data. (7) Subjects known to be allergic to the active ingredients or excipients of the study drug. (8) Patients with poorly controlled blood glucose levels due to diabetes. (9) Poor control of hypertension (systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg under conventional antihypertensive treatment), with a history of hypertensive crisis or hypertensive encephalopathy; (10) 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 aneurysm requiring surgical repair or recent arterial thrombosis); patients with poorly controlled clinical symptoms or heart diseases, such as unstable angina pectoris, New York Heart Association (NYHA) heart failure grade II or above, left ventricular ejection fraction < 50% as detected by color Doppler echocardiography, or severe arrhythmia that cannot be controlled by drug treatment. (11) Pregnant or lactating women. (12) Other situations deemed by the researchers as unsuitable for enrollment.
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 ContactXuelein Ma
West China Hospital, Sichuan University
Outcome results
None listed