Could cutting one amino acid make rectal cancer treatment more effective?
NCT ID NCT07755124
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This trial tests whether an arginine-free diet, given as a liquid formula for four weeks, can enhance the effects of standard chemoradiotherapy in people with locally advanced rectal cancer. The study first checks the diet's safety in a small group, then randomly assigns about 134 participants to receive either the diet plus chemoradiotherapy or chemoradiotherapy alone. The main goal is to see if the diet increases the chance of the tumor completely disappearing after treatment.
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-free liquid diet formula combined with short-course radiotherapy and chemotherapy
- What this could lead to
- If successful, this could lead to a new dietary strategy to improve tumor response and potentially increase the chance of complete remission in rectal cancer patients.
- What could go wrong
- This is an early-phase trial, so the diet's benefit is uncertain. It may not improve outcomes and could cause nutritional deficiencies or other side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- 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 80 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: * Signed written informed consent prior to any study-related procedures. * Male or female, aged 18 to 80 years. * Locally advanced mid-low rectal cancer staged as cT3, cT4, or node-positive by rectal MRI. * ECOG performance status 0-1. * NRS-2002 score \< 3. * BMI ≥ 18.5 kg/m² (may be adjusted based on actual conditions). * Able to take food orally or via feeding tube and tolerate enteral nutrition. * Adequate organ function as defined by the following laboratory criteria: 1. ANC ≥ 1.5 × 10⁹/L (no G-CSF within 14 days); 2. Platelet count ≥ 100 × 10⁹/L; 3. Hemoglobin ≥ 9 g/dL (no transfusion or erythropoietin within 7 days); 4. Serum albumin ≥ 3.0 g/dL; 5. Total bilirubin ≤ 1.5 × ULN; 6. AST/ALT ≤ 2.5 × ULN; 7. Creatinine clearance ≥ 50 mL/min or serum creatinine ≤ 1.5 × ULN; 8. INR ≤ 1.5 × ULN, PT and APTT ≤ 1.5 × ULN; 9. Urine protein \< 2+ (if ≥ 2+, 24-hour urine protein \< 2.0 g allowed); 10. Cardiac enzyme profile within normal limits. * Women of childbearing potential must agree to use reliable contraception from signing informed consent to at least 6 months after the last dose, with a negative serum HCG test within 3 days before treatment and non-lactating status. * All participants at risk of pregnancy must use contraceptive methods with a failure rate of \< 1% per year throughout treatment until 120 days after the last study drug dose (or 180 days after the last chemotherapy). Exclusion Criteria: * Stage I or IV rectal cancer. * Cognitive impairment or psychiatric disorders that interfere with understanding the study content. * Central nervous system or meningeal metastases. * Clinically symptomatic moderate or severe ascites (requiring therapeutic paracentesis within 2 weeks before starting study treatment; patients with minimal asymptomatic ascites on imaging may be enrolled). * Uncontrolled or moderate to severe pleural effusion and pericardial effusion. * Severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralytic or mechanical intestinal obstruction; tracheoesophageal fistula, gastrointestinal perforation or fistula, or intra-abdominal abscess; gastrointestinal bleeding with CTCAE grade ≥ 3 within 6 months or CTCAE grade ≥ 2 within 3 months before study treatment. * Other factors that may affect study results or cause forced termination (as judged by the investigator), such as alcoholism, drug abuse, other serious diseases requiring combined treatment (including psychiatric disorders), severe laboratory abnormalities, family or social factors, and other conditions that may affect patient safety or study data collection. * Known allergy to active ingredients or excipients of the study drug or nutritional powder. * Poorly controlled diabetes mellitus. * Severe cardiovascular and cerebrovascular diseases, including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, and major vascular diseases within 6 months before enrollment; poorly controlled symptomatic cardiac diseases, such as unstable angina, NYHA class ≥ II heart failure, LVEF \< 50% on echocardiography, or severe arrhythmia uncontrolled by medication. * Pregnancy or lactation. * Other conditions deemed unsuitable for enrollment by the investigator.
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Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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