Solid Tumor CancerPhase 1NCT07038044

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

A Phase 1 study testing Arginine-restricted diet in people with Solid Tumor Cancer, run by West China Hospital at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Solid Tumor Cancer
What is being tested?: Arginine-restricted diet
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 2 sitesChina
Study dates: 12 May 2025to 25 Sep 2025
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Sign a written informed consent form before any study - related procedures are carried out.
Males or females, aged 18 - 75 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.

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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).

Who cannot join

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.

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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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Xinjin District Hospital of Traditional Chinese Medicine
Chengdu, Sichuan, 611430

Other trials in China

About this study

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
Being tested: Arginine-restricted diet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Arginine-restricted dietDietary 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.

Study groups in NCT07038044
Study group	Role	What they receive
Arginine-restricted diet + conventional anti-tumor treatment	Experimental	Not described Receives: Dietary Supplement: Arginine-restricted diet

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: From enrollment to the end of treatment at 6 weeks

Secondary outcomes (3)

Objective Response Rate (ORR)
Evaluate the effectiveness of arginine - restricted diet in patients with solid tumors.
Measured: From enrollment to the end of treatment at 1 year
Disease Control Rate (DCR)
Evaluate the effectiveness of arginine - restricted diet in patients with solid tumors.
Measured: From enrollment to the end of treatment at 1 year
Duration of Response (DoR)
Evaluate the effectiveness of arginine - restricted diet in patients with solid tumors.
Measured: From enrollment to the end of treatment at 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 May 202525 Sep 2025

First posted26 Jun 2025
Study start12 May 2025
Primary completion18 Sep 2025
Study completion25 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid Tumor CancerStudies of the same condition, open and under way.
More trials run by West China HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Arginine-restricted diet
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07038044
Sponsor's protocol ID: Approval No. 383 (2025)
Status last verified: Sep 2026
First submitted: 15 Apr 2025
Last updated: 9 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumor Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of an Arginine-Restricted Diet in Patients With Solid Tumors
ClinicalTrials.gov ID: NCT07038044
Acronym / sponsor ID: Approval No. 383 (2025)
Conditions: Solid Tumor Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: West China HospitalUniversity, hospital or other
Collaborators: Xinjin District Hospital of Traditional Chinese Medicine
Study start: 12 May 2025 (actual)
Primary completion: 18 Sep 2025 (actual)
Study completion: 25 Sep 2025 (actual)
First posted: 26 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Arginine-restricted diet

Arm	Type	Receives
Arginine-restricted diet + conventional anti-tumor treatment	Experimental	Dietary Supplement: Arginine-restricted diet

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Sign a written informed consent form before any study - related procedures are carried out.
Males or females, aged 18 - 75 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.

Key exclusion criteria (11 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Arginine-restricted dietTargeted 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.	Dietary supplement	Arginine-restricted diet + conventional anti-tumor treatment

Primary outcome

Evaluate the safety and tolerability of arginine - restricted diet (-Arg diet) in patients with solid tumors.
Time frame: From enrollment to the end of treatment at 6 weeks
The occurrence types, frequencies, and severities of treatment - emergent adverse events (TEAE).

3 secondary outcomes

Objective Response Rate (ORR)
Time frame: From enrollment to the end of treatment at 1 year
Disease Control Rate (DCR)
Time frame: From enrollment to the end of treatment at 1 year
Duration of Response (DoR)
Time frame: From enrollment to the end of treatment at 1 year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
Individual participant dataSharing planned: No

Related trials for Solid Tumor Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Arginine-restricted diet in people with Solid Tumor Cancer, run by West China Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the safety and tolerability of arginine - restricted diet (-Arg diet) in patients with solid tumors. (time frame: From enrollment to the end of treatment at 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07038044.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.