Can cutting arginine from the diet starve solid tumors?
NCT ID NCT07038044
First seen Aug 24, 2026 · Last updated Sep 09, 2026 · Updated 2 times
Summary
This phase 1 trial is testing whether a diet that severely limits arginine—an amino acid some tumors depend on—is safe and might help control solid tumors. About 25 adults with solid tumors will follow a specially designed low-arginine liquid diet for two 3-week cycles while continuing their usual anti-cancer treatment. Researchers will track side effects, tumor response, and quality of life to see if this dietary approach could become a supportive part of cancer care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an arginine-restricted diet (a liquid diet with very low arginine content)
- What this could lead to
- If successful, this diet could become a supportive strategy to help control tumor growth in people with solid tumors, potentially improving treatment outcomes.
- What could go wrong
- This is a small, early-phase study, so results may not apply broadly. The diet is restrictive and may be hard to follow, and it is unknown if it will meaningfully affect tumors or cause side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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25 people
The number who actually took part.
- Started
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May 2025
- Finished
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Sep 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Sign a written informed consent form before any study - related procedures are carried out. 2. Males or females, aged 18 - 75 years old. 3. Diagnosed with solid tumors by pathological tissue biopsy. 4. 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). 5. ECOG (Eastern Cooperative Oncology Group Performance Status) score of 0 - 1. 6. NRS - 2002 (Nutritional Risk Screening 2002) score \< 3. 7. BMI (Body Mass Index) ≥ 18.5 (can be adjusted appropriately according to the actual situation). 8. Patients who can eat orally or through a feeding tube and can tolerate enteral nutrition. 9. 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). 10. 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). 11. 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: 1. Patients with cognitive impairment or mental illness who are unable to understand the study content. 2. Patients with central nervous system or meningeal metastases. 3. 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). 4. Patients with uncontrolled or moderate to severe pleural effusion and pericardial effusion. 5. 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). 6. Patients known to be allergic to the active ingredients or excipients of the study drug. 7. Patients with poorly controlled diabetes. 8. 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. 9. 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. 10. Pregnant or lactating women. 11. Other situations considered by the investigator as inappropriate for enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
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Xinjin District Hospital of Traditional Chinese Medicine
Chengdu, Sichuan, 611430, China
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