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NCT07359989

Leucine Plus Radiochemotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cancer

Recruiting now NA Last updated 22 January 2026
What this trial tests

NA trial testing Oral administration of Leucine in Rectal Cancer in 33 participants. Currently enrolling.

Timeline
11 June 2025
Primary endpoint
31 December 2027
31 December 2030

Quick facts

Lead sponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment33
Start date11 June 2025
Primary completion31 December 2027
Estimated completion31 December 2030
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Adults 18 to 80, any sex, with Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Rectal Cancer

Currently open trials in the same condition.

Other Second Affiliated Hospital, School of Medicine, Zhejiang University trials

Trials by the same sponsor.

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Data sources for this page

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