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Rectal CancerNCT07359989

Leucine Plus Radiochemotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cancer

A study testing Oral administration of Leucine in people with Rectal Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Colorectal cancer (CRC), a prevalent gastrointestinal malignancy, is experiencing a rising incidence in China. Rectal cancer constitutes nearly half of all new CRC cases, with over half of these patients diagnosed at a locally advanced stage. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Rectal Cancer
What is being tested?
Oral administration of Leucine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteChina
Study dates
11 Jun 2025to 31 Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient voluntarily participates in this study, signs the Informed Consent Form, demonstrates good compliance, and cooperate with follow-up;
  • Aged 18 to 80 years (inclusive), both male and female are eligible;
  • Histologically confirmed and assessed as locally advanced rectal adenocarcinoma (confirmed by MRI): cT3 or higher; or cN+;
  • MRI confirms that the lower edge of the tumor is ≤10 cm from the anal verge;
  • No prior anti-tumor treatment for rectal cancer (except for traditional Chinese medicine treatments);
  • ECOG score of 0-1;
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  • 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;
  • 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);
  • 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.

Who cannot join

  • Patients with locally recurrent rectal cancer after previous treatment;
  • Patients assessed by the investigator as having initially unresectable rectal cancer or those deemed unable to tolerate surgery;
  • Clinical or imaging evidence suggests distant metastasis or positive lateral lymph nodes;
  • Patients with multiple colorectal cancer lesions;
  • Clinical or imaging evidence suggests bowel obstruction or perforation, or the investigator evaluates a high risk of perforation or bleeding;
  • Factors deemed by the investigator to make the patient unsuitable for long-course radiotherapy;
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  • 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;
  • 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;
  • 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;
  • Difficulty swallowing or other factors affecting oral medication use;
  • Contraindications to MRI;
  • 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);
  • History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation;
  • 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;
  • 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;
  • 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);
  • 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);
  • Known allergy, hypersensitivity, or contraindications to pucotenlimab, oxaliplatin, capecitabine, or any component of their formulations;
  • 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;
  • 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);
  • 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;
  • 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;
  • Pregnant or breastfeeding women;
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Haiyan Chen, Doctor contact

86-86992821

chenhaiyan@zju.edu.cn

China1 site, 1 recruiting

  • Second Affiliated Hospital Of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

    Haiyan Chen, Doctor, 86-86992821, chenhaiyan@zju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Leucine Combined With Radiotherapy and Chemotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer: A Single-Arm Clinical Study

Colorectal cancer (CRC), a prevalent gastrointestinal malignancy, is experiencing a rising incidence in China. Rectal cancer constitutes nearly half of all new CRC cases, with over half of these patients diagnosed at a locally advanced stage. While neoadjuvant chemoradiotherapy is the standard of care for these patients, it yields a pathological complete response in only 10-30% of cases, and the risk of recurrence and metastasis remains suboptimal.

The role of amino acid metabolism in cancer therapy is gaining significant interest. Our preliminary data reveal that leucine-derived metabolite significantly impairs cellular DNA damage repair and enhances the efficacy of radiotherapy. However, it remains unknown whether combining leucine with chemoradiotherapy can improve tumor regression and survival in patients with locally advanced rectal cancer.

The goal of this single-arm clinical trial is to evaluate the safety and efficacy of Leucine combined with neoadjuvant chemoradiotherapy for locally advanced rectal cancer, potentially offering a new therapeutic option.

Conditions
Rectal Cancer
Being tested
Oral administration of Leucine
Keywords
Rectal Cancer, Leucine
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • Oral administration of LeucineDietary supplement

    Oral administration of leucine during radiotherapy

Study groups in NCT07359989
Study groupRoleWhat they receive
Leucine plus Radiotherapy and ChemotherapyExperimentalLeucine plus radiotherapy and chemotherapy as neoadjuvant therapy
Receives: Dietary Supplement: Oral administration of Leucine

What is being measured

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

  1. The Pathological complete response (pCR) rate

    The definition of pCR is that after surgery, in the pathological evaluation of the resected rectal cancer lesion, mesorectum, and regional lymph node samples, there are no visible tumor cells under the microscope. Tumor cells refer to viable tumor cells, excluding degenerated or necrotic cells. Pools of acellular mucin should not be assessed as residual tumor.

    Measured: From enrollment to the end of treatment at 16 weeks.

  2. Clinical complete response (cCR) rate

    The cCR assessment is defined by the fulfillment of the following three criteria:

    1. Digital rectal examination of the original tumor area shows normal findings, with no palpable tumor masses.
    2. Endoscopy reveals white, flat mucosal scars accompanied by surrounding capillary ectasia, without evidence of tumor ulcers or nodules; mucosal biopsy results are negative for cancer cells.
    3. Contrast-enhanced MRI of the rectum shows: On T2-weighted images, only low signal intensity (dark on T2) is present without intermediate T2 signal intensity, and there are no signs of enlarged lymph nodes. there is no visible signal on diffusion-weighted (DW) images.

    Measured: From enrollment to the end of treatment at 12 weeks.

Secondary outcomes (5)

  1. Adverse events.

    The incidence, type, and severity of adverse events (AEs), serious AEs, and immune-related AEs (irAEs) were assessed in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 5.0).

    Measured: From enrollment to the end of treatment at 3 years.

  2. The rate of TRG0

    Complete regression, defined as no residual tumor cells in the primary tumor and regional LNs (ypT0N0)

    Measured: From enrollment to the end of treatment at 16 weeks

  3. The rate of R0 resection

    R0 resection is defined as the removal of the rectal cancer lesion during surgery with no tumor cells present within 1 mm of the resection margins.

    Measured: From enrollment to the end of treatment at 16 weeks.

  4. Event-Free Survival

    Event-Free Survival (EFS) was defined as the period from the date of first treatment administration to the date of the first documented relevant event, where relevant events include disease progression that leads to inoperability, local recurrence or distant metastasis after surgery, and death due to any cause.

    Measured: From enrollment to the end of treatment at 3 years

  5. Overall Survival

    OS (Overall Survival) is defined as the period from the date of first treatment administration to the date of death due to any cause.

    Measured: From enrollment to the end of treatment at 3 years

Timeline

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

  1. First posted22 Jan 2026
  2. Study start11 Jun 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07359989
Sponsor's protocol ID
IIT 2025-0428
Status last verified
Mar 2025
First submitted
13 Jan 2026
Last updated
22 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Oral administration of Leucine in people with Rectal Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site 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 10 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Haiyan Chen, Doctor (86-86992821, chenhaiyan@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Pathological complete response (pCR) rate (time frame: From enrollment to the end of treatment at 16 weeks.). The study lists 2 primary outcomes in all. 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 NCT07359989.

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 22 Jan 2026.

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