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Could cutting one amino acid make rectal cancer treatment more effective?

NCT ID NCT07755124

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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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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

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  1. The official record

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