RecruitingNot ApplicableNCT07359989

Leucine Plus Radiochemotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cancer

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


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

33 participants

Start Date

Jun 11, 2025

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding leucine (an amino acid found in protein-rich foods) to standard chemoradiation treatment before surgery improves outcomes for people with locally advanced rectal cancer, potentially helping the body better respond to therapy. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with locally advanced rectal adenocarcinoma (cancer in the lower bowel) confirmed by MRI — specifically cT3 or higher, or cancer that has spread to nearby lymph nodes - The bottom edge of your tumor is within 10 cm of the anal opening - You have not had any prior treatment for rectal cancer - You are in good enough health to receive chemoradiation (ECOG 0–1) **You may NOT be eligible if...** - You have already received treatment for rectal cancer (other than traditional Chinese medicine) - You have had a heart attack, stroke, or uncontrolled heart failure in the past 6 months - You have severe kidney or liver problems - You are pregnant or breastfeeding - Your blood counts or organ function do not meet minimum safety thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTOral administration of Leucine

Oral administration of leucine during radiotherapy


Locations(1)

Second Affiliated Hospital Of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT07359989


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