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NCT05563922: OP-TNT
Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma
Phase 2 trial testing Total Neoadjuvant Chemoradiotherapy in Rectal Cancer in 56 participants. Currently enrolling.
31 August 2025
Quick facts
| Lead sponsor | Shanghai Zhongshan Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 1 September 2022 |
| Primary completion | 31 August 2025 |
| Estimated completion | 31 August 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- Total Neoadjuvant Chemoradiotherapy
Conditions studied
- Rectal Cancer — all drugs for Rectal Cancer →
Sponsor
Shanghai Zhongshan Hospital
Who can join
Adults 18 to 75, any sex, with Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to evaluate the efficacy and safety of an organ-sparing strategy after neoadjuvant chemoradiotherapy followed by transanal endoscopic microsurgery (TEM) or endoscopic local resection for early low rectal cancer(cT 1-3N0M0).Besides, the clinical complete response rate and near-clinical complete response rate, organ preservation rate, local recurrence rate, distant metastasis rate and quality of life (QoL) will also be assessed.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05563922
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
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Currently open trials in the same condition.
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Other Shanghai Zhongshan Hospital trials
Trials by the same sponsor.
- NCT07353476 — Radiotherapy Plus Anti-PD-1 Versus Anti-PD-1 Alone in ypTanyN⁺M0 NSCLC · Phase 2 · not yet recruiting
- NCT07508956 — Feasibility of Circulating Tumor DNA Based Minimal Residual Disease-Guided Adjuvant Therapy in Locally Advanced Gastric · Phase 3 · not yet recruiting
- NCT07535632 — SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cance · Phase 2 · not yet recruiting
- NCT07531368 — BBAP With CS Mapping Guidance · NA · not yet recruiting
- NCT07501104 — Neoadjuvant Pucotenlimab Combined With Lenvatinib and Temozolomide in Resectable Stage IIB/III Acral Melanoma · Phase 2 · not yet recruiting
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 NCT05563922 (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 Shanghai Zhongshan Hospital
- Last refreshed: 3 October 2022
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/NCT05563922.
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