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

NCT07038044 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: Approval No. 383 (2025)
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase I single-arm clinical study conducted by West China Hospital of Sichuan University. The research duration is from March 2025 to March 2027, aiming to evaluate the safety and efficacy of arginine-restricted diet (-Arg diet) in patients with solid tumors. A total of 25 patients with solid tumors, aged 18 - 75 years old, who meet specific inclusion criteria such as having at least one measurable lesion according to RECIST v1.1 criteria and an ECOG score of 0 - 1, will be enrolled. Patients will receive -Arg diet intervention for 2 cycles (3 weeks per cycle) while continuing their original anti-tumor treatment. The -Arg diet strictly limits arginine intake, and patients can only consume foods with extremely low arginine content. The research will collect data on patients' basic information, nutritional status, blood, immunity, and tumor imaging at baseline and during follow - up. The primary endpoint of the study is the occurrence type, frequency, and severity of treatment-related adverse events (TEAE). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), and duration of response (DoR). Exploratory endpoints involve evaluating the nutritional adequacy of the -Arg diet, its impact on patients' quality of life, and its influence on amino acid metabolism and immune status in patients. During the study, safety will be evaluated by closely monitoring adverse events according to NCI CTCAE (version 5.0), and efficacy will be assessed using RECIST 1.1 standard. Statistical analysis will be performed using SAS 9.4 software, including descriptive statistics for safety and efficacy data, and calculating confidence intervals for relevant indicators. This study hopes to provide new strategies and directions for the treatment of advanced solid tumors.

Conditions

Solid Tumor Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety and tolerability of arginine - restricted diet (-Arg diet) in patients with solid tumors.

  The occurrence types, frequencies, and severities of treatment - emergent adverse events (TEAE).

  From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  From enrollment to the end of treatment at 1 year

• Disease Control Rate (DCR)

  From enrollment to the end of treatment at 1 year

• Duration of Response (DoR)

  From enrollment to the end of treatment at 1 year

Study Arms (1)

Arginine-restricted diet + conventional anti-tumor treatment

EXPERIMENTAL

Dietary Supplement: Arginine-restricted diet

Interventions

Arginine-restricted diet DIETARY_SUPPLEMENT

Targeted Arginine Metabolism: The intervention zeroes in on arginine metabolism. As solid tumors often have arginine synthesis flaws and rely on external arginine, dietary restriction of arginine is a novel approach. Dietary Intervention: The -Arg liquid diet in this study is precisely defined. Dosage is determined by patient weight, following 30 kcal/kg/day for energy and 1.5 g/kg/day for protein. A low - arginine food list is provided. Study Design and Endpoints: It's a Phase I single - arm study. Its main goal is to evaluate the safety and tolerance of the combined treatment. Secondary and exploratory endpoints cover efficacy, nutritional state, and immune status.

Arginine-restricted diet + conventional anti-tumor treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Biotherapy, Cancer Center and State Key Laboratory of Biotherapy, West China Hospital

Model Details: Arginine-restricted diet

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: June 26, 2025
• Study Start: June 1, 2025
• Primary Completion: July 31, 2025
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share