Could a simple supplement make rectal cancer treatment more effective?

NCT ID NCT07359989

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether adding leucine, a common amino acid found in food, to standard chemoradiotherapy can help shrink tumors more effectively in people with locally advanced rectal cancer. The researchers believe leucine may interfere with cancer cells' ability to repair DNA damage caused by radiation. The trial will enroll 33 participants and measure how many achieve a complete response (no cancer cells visible 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
Leucine (a dietary supplement)
What this could lead to
If it works, this could point toward a simple, low-cost way to boost the effectiveness of standard chemoradiotherapy for rectal cancer.
What could go wrong
This is a very early, small (33 people), single-arm trial with no placebo group, so results may not be reliable. Leucine's benefit is unproven, and side effects from the combination are unknown.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 33 people

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

Started

Jun 2025

Expected to finish

Dec 2030

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: 1. The patient voluntarily participates in this study, signs the Informed Consent Form, demonstrates good compliance, and cooperate with follow-up; 2. Aged 18 to 80 years (inclusive), both male and female are eligible; 3. Histologically confirmed and assessed as locally advanced rectal adenocarcinoma (confirmed by MRI): cT3 or higher; or cN+; 4. MRI confirms that the lower edge of the tumor is ≤10 cm from the anal verge; 5. No prior anti-tumor treatment for rectal cancer (except for traditional Chinese medicine treatments); 6. ECOG score of 0-1; 7. Major organs or functions meet the following criteria (within 2 weeks before the test, no use of any blood components or growth factors for correction is allowed): Absolute neutrophil count (ANC) ≥1.5×10\^9/L; Platelets ≥100×10\^9/L; Hemoglobin ≥10 g/dL; Serum albumin ≥3.0 g/dL; Total bilirubin ≤ ULN, ALT, AST, and/or AKP ≤2.5 × ULN; Serum creatinine ≤ ULN or creatinine clearance rate ≥60 mL/min; International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ ULN; 8. Female patients of childbearing potential must agree to abstain from heterosexual intercourse or use reliable and effective contraception from the time of signing the informed consent form until at least 6 months after the last dose of study drug. A serum HCG test must be negative within 7 days before starting treatment, and the woman must not be breastfeeding. A woman is considered of childbearing potential if she has had menstruation, has not reached postmenopausal status (absence of menstruation for ≥12 consecutive months without any other cause), and has not undergone sterilization surgery (such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy); 9. Male patients with female partners of childbearing potential must agree to abstain from intercourse or use reliable and effective contraception from the time of signing the informed consent form until at least 6 months after the last dose of study drug. Male patients must also agree not to donate sperm during this period. Male patients with pregnant partners should use a condom, without the need for additional contraceptive methods. Exclusion Criteria: 1. Patients with locally recurrent rectal cancer after previous treatment; 2. Patients assessed by the investigator as having initially unresectable rectal cancer or those deemed unable to tolerate surgery; 3. Clinical or imaging evidence suggests distant metastasis or positive lateral lymph nodes; 4. Patients with multiple colorectal cancer lesions; 5. Clinical or imaging evidence suggests bowel obstruction or perforation, or the investigator evaluates a high risk of perforation or bleeding; 6. Factors deemed by the investigator to make the patient unsuitable for long-course radiotherapy; 7. Severe cardiovascular or cerebrovascular diseases, including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, or significant vascular disease (such as an aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to enrollment; poorly controlled cardiac symptoms or diseases, such as unstable angina, NYHA class II or higher heart failure, left ventricular ejection fraction \<50% by echocardiography, or severe arrhythmias not controlled by medication; 8. History of active pulmonary tuberculosis detected by medical history or CT, active pulmonary tuberculosis within 1 year before enrollment, or a history of active tuberculosis more than 1 year ago that was not properly treated; 9. Major surgery within 3 months before starting study treatment (major surgery is defined as surgery performed under general anesthesia); presence of non-healing wounds (severe, non-healing or dehiscent), active peptic ulcers, or untreated fractures; 10. Difficulty swallowing or other factors affecting oral medication use; 11. Contraindications to MRI; 12. Active autoimmune disease or history of autoimmune diseases (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism \[patients controlled by thyroid hormone replacement therapy can be included\]); patients with skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, alopecia), controlled type 1 diabetes treated with insulin, and childhood asthma that has fully resolved and requires no intervention in adulthood may be included (patients requiring bronchial dilation for asthma cannot be included); 13. History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation; 14. Severe infections within 4 weeks before the first use of the study drug (CTCAE \> Grade 2), such as severe pneumonia, bacteremia, or infections requiring hospitalization; active lung inflammation on baseline chest imaging, signs and symptoms of infection requiring oral or intravenous antibiotics within 2 weeks before the first use of the study drug, except for prophylactic antibiotics; 15. Current or past history of interstitial lung disease or interstitial pneumonitis requiring steroid therapy, or other conditions (e.g., lung fibrosis, organizing pneumonia such as bronchiolitis obliterans) that may interfere with the assessment and management of immune-related lung toxicity, evidence of active pneumonia on screening chest CT, or severely impaired lung function; 16. Active hepatitis B (HbsAg positive, and HBV-DNA ≥ 2,500 copies/ml or 500 IU/ml) or active hepatitis C (HCV antibody positive and HCV-RNA above the detection limit); co-infection with hepatitis B and hepatitis C (HbsAg or HbcAb positive and HCV antibody positive); 17. Diagnosis of another malignancy within 5 years prior to the first use of the study drug (patients with effectively treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or effectively excised in situ cervical or breast cancer may be included upon evaluation, but those who previously received immunotherapy, chemotherapy, targeted therapy, or radiation therapy cannot be included); 18. Known allergy, hypersensitivity, or contraindications to pucotenlimab, oxaliplatin, capecitabine, or any component of their formulations; 19. Use of immunosuppressants or corticosteroids (dose \>10 mg/day prednisone or equivalent) for immunosuppression within 14 days before starting study treatment; inhaled or topical steroids are allowed in the absence of active autoimmune disease, and hormone replacement therapy with ≤10 mg/day prednisone or equivalent is permitted; 20. Participation in another clinical study within 4 weeks before the first use of the study drug (for participants in the follow-up phase of another study, the time is calculated from the last use of investigational drug or device); 21. Laboratory abnormalities of sodium, potassium, or calcium greater than Grade 1 within 2 weeks before the start of study treatment that cannot be corrected with treatment; 22. Receipt of live attenuated vaccines within 28 days before starting study treatment or planning to receive such vaccines during the treatment period or within 60 days after the last dose of the study drug; 23. Pregnant or breastfeeding women; 24. Any other factors, as judged by the investigator, that may affect the study results or lead to premature termination, such as alcohol abuse, drug abuse, other serious diseases (including mental disorders) requiring concomitant treatment, severe laboratory abnormalities, family or social factors, and other conditions that may affect participant safety or data collection.

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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

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Second Affiliated Hospital Of Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310009, China

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