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NCT07359989
Leucine Plus Radiochemotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cancer
NA trial testing Oral administration of Leucine in Rectal Cancer in 33 participants. Currently enrolling.
31 December 2027
Quick facts
| Lead sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 11 June 2025 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 December 2030 |
| Sites | 1 location across China |
Drugs / interventions tested
- Oral administration of Leucine
Conditions studied
- Rectal Cancer — all drugs for Rectal Cancer →
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.
Verify or expand the search:
- PubMed search for NCT07359989
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Second Affiliated Hospital, School of Medicine, Zhejiang University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07359989 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Second Affiliated Hospital, School of Medicine, Zhejiang University
- Last refreshed: 22 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07359989.
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