Bone-originating tumor
Conditions
Interventions
Trial group:Valine-restricted diet(-Val diet)
Sponsors
Shanghai General Hospital, Shanghai Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent must be obtained prior to any trial-related procedures; 2. Male or female, aged 18–75 years; 3. Histopathologically confirmed diagnosis of osteogenic tumor; 4. At least one measurable lesion according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumors Version 1.1); lesions previously treated with local therapies such as radiotherapy are not considered measurable; 5. ECOG (Eastern Cooperative Oncology Group Performance Status) score of 0–1; 6. NRS-2002 (Nutritional Risk Screening 2002) score =18.5 (may be adjusted appropriately based on clinical judgment); 8. Able to take oral intake or enteral nutrition via feeding tube and able to tolerate enteral nutrition; 9. Adequate organ function, as defined by the following laboratory criteria: (1) Absolute neutrophil count >=1.5×10^9/L in the absence of granulocyte colony-stimulating factor use within the past 14 days; (2) Platelet count >=75×10^9/L; (3) Hemoglobin >=8 g/dL in the absence of blood transfusion or erythropoiesis-stimulating agent use within the past 7 days; (4) Serum albumin >=3.0 g/dL; (5) Total bilirubin =50 mL/min (calculated by Cockcroft-Gault formula) or serum creatinine =2+, a 24-hour urinary protein quantification may be performed; subjects with 24-hour urinary protein <2.0 g are eligible); 10. Women of childbearing potential must agree to avoid heterosexual intercourse or use highly effective contraceptive methods with a failure rate of <1% from the time of signing informed consent until at least 6 months after the last dose of study drug; serum HCG (Human Chorionic Gonadotropin) must be negative within 3 days prior to initiation of study treatment, and the subject must not be lactating; a female is considered to have childbearing potential if she is postmenopausal but has not met the definition of menopause (i.e., no menstrual periods for <12 consecutive months, or other causes beyond menopause are present) and has not undergone sterilization procedures (e.g., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy); 11. All subjects with childbearing potential (regardless of sex) must use highly effective contraceptive methods with a failure rate of <1% throughout the treatment period and until 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy).
Exclusion criteria
Exclusion criteria: 1. Patients with cognitive impairment or psychiatric disorders that prevent understanding of the study content; 2. Patients with central nervous system or leptomeningeal metastases; 3. Patients with moderate or severe symptomatic ascites (i.e., those requiring therapeutic paracentesis within 2 weeks prior to initiation of study treatment; patients with only minimal ascites on imaging and no clinical symptoms may be enrolled); 4. Uncontrolled or moderate-to-severe pleural effusion or pericardial effusion; 5. Severe diarrhea, refractory vomiting, severe malabsorption syndrome, paralytic or mechanical intestinal obstruction; tracheoesophageal fistula, gastrointestinal perforation, gastrointestinal fistula, or intra-abdominal abscess; gastrointestinal bleeding of CTCAE (Common Terminology Criteria for Adverse Events) Grade 3 or higher within 6 months prior to study treatment initiation, or Grade 2 or higher within 3 months (e.g., abnormal vaginal bleeding, hematemesis); 6. Other factors that may affect study outcomes or lead to premature study discontinuation, as determined by the investigator, including but not limited to: alcohol abuse, drug misuse, coexisting severe diseases requiring concomitant therapy (e.g., psychiatric disorders), significantly abnormal laboratory values, familial or social factors, or other conditions that may compromise subject safety or data integrity; 7. Patients with known hypersensitivity to the active ingredient or any excipient of the study drug; 8. Patients with poorly controlled diabetes; 9. Poorly controlled hypertension (systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg despite standard antihypertensive therapy), or history of hypertensive crisis or hypertensive encephalopathy; 10. Severe cardiovascular or cerebrovascular diseases, including: cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, major vascular disease (occurring within 6 months prior to enrollment, such as an aortic aneurysm requiring surgical repair or recent arterial thrombosis); uncontrolled cardiac conditions, such as unstable angina, NYHA (New York Heart Association) heart failure class II or higher, left ventricular ejection fraction <50% on echocardiography, or severe arrhythmias uncontrolled by medication; 11. Pregnant or lactating women; 12. Any other condition deemed unsuitable for enrollment by the investigator.
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 ContactMeng Tong
Shanghai General Hospital, Shanghai Jiaotong University
Outcome results
None listed