Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07359989

Leucine Plus Radiochemotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cancer

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-01-22

33

Participants Needed

1

Research Sites

289 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Leucine Plus Radiochemotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cancer

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily agrees to participate and can comply with study procedures and follow-up
  • Aged between 18 and 80 years, any gender
  • Diagnosed with locally advanced rectal adenocarcinoma confirmed by MRI (cT3 or higher; or cN+)
  • Tumor located 10 cm or less from the anal verge as confirmed by MRI
  • No prior anti-tumor treatments for rectal cancer except traditional Chinese medicine
  • ECOG performance score of 0 or 1
  • Adequate blood counts and organ function within 2 weeks before treatment without blood component or growth factor correction
  • Female participants of childbearing potential must use effective contraception and have a negative serum HCG test before treatment; must not be breastfeeding
  • Male participants with partners of childbearing potential must use effective contraception and agree to abstain from sperm donation during study and 6 months after
Not Eligible

You will not qualify if you...

  • Locally recurrent rectal cancer after previous treatment
  • Initially unresectable rectal cancer or unable to tolerate surgery
  • Evidence of distant metastasis or positive lateral lymph nodes
  • Multiple colorectal cancer lesions
  • Bowel obstruction, perforation, or high risk of perforation or bleeding
  • Unsuitable for long-course radiotherapy as judged by investigator
  • Severe cardiovascular or cerebrovascular diseases within 6 months, or poorly controlled cardiac conditions
  • Active or untreated pulmonary tuberculosis
  • Major surgery within 3 months before study or non-healing wounds, active ulcers, or untreated fractures
  • Difficulty swallowing or other issues affecting oral medication
  • Contraindications to MRI
  • Active autoimmune diseases or history of such diseases requiring systemic treatment (with some exceptions)
  • History of immunodeficiency or organ/bone marrow transplantation
  • Severe infections within 4 weeks before treatment
  • Current or past interstitial lung disease or severe lung conditions
  • Active hepatitis B or C infection
  • Other malignancies diagnosed within 5 years except certain treated skin and cervical/breast cancers
  • Known allergies to study drugs
  • Use of immunosuppressants or corticosteroids above specified doses before treatment
  • Participation in another clinical trial within 4 weeks before study
  • Uncorrected significant electrolyte abnormalities
  • Receipt of live vaccines shortly before or during study
  • Pregnant or breastfeeding
  • Other factors deemed by investigator to affect study or safety

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Second Affiliated Hospital Of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310009

Actively Recruiting

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Research Team

H

Haiyan Chen, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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