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NCT05009446: SNMM
Single Arm Study of Induction Chemoradiotherapy Combined With Surgery in the Treatment of Locally Advanced SNMM
EARLY_PHASE1 trial testing endoscopic surgery in Mucosal Melanoma in 28 participants. Status unknown.
10 August 2025
Quick facts
| Lead sponsor | Eye & ENT Hospital of Fudan University |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 28 |
| Start date | 10 August 2021 |
| Primary completion | 10 August 2025 |
| Estimated completion | 10 August 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- endoscopic surgery
- intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapy
- Chemotherapy drug — full drug profile →
Conditions studied
- Mucosal Melanoma — all drugs for Mucosal Melanoma →
- Sinonasal Melanoma — all drugs for Sinonasal Melanoma →
Sponsor
Eye & ENT Hospital of Fudan University
Who can join
18 and older, any sex, with Mucosal Melanoma or Sinonasal Melanoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Sinonasal mucosal melanoma (SNMM) is a very rare tumor, and SNMM is highly aggressive in nature, with a 5-year survival rate of about 20\~30%. Most patients underwent local recurrence and distant metastasis within one or two years of treatment. There is no unified standard for the treatment of SNMM.The principle of treatment for surgically resectable stage T3 and partial T4 SNMM is complete resection of the primary tumor, combined with postoperative radiotherapy. While locally unresectable SNMM has a poorer prognosis, lower incidence, fewer clinical data have been reported. This study will explore the role of preoperative radiotherapy and chemotherapy in improving the 2-year OS rate, loco-regional control rate and distant metastasis rate.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
A future directions of renal cell carcinoma treatment: combination of immune checkpoint inhibition and carbon ion radiotherapy.
Zheng Z, Yang T, Li Y, Qu P, et al · · 2024 · cited 9× · PMID 39091498 · DOI 10.3389/fimmu.2024.1428584 -
Flourish of Proton and Carbon Ion Radiotherapy in China.
Li Y, Li X, Yang J, Wang S, et al · · 2022 · cited 9× · PMID 35237518 · DOI 10.3389/fonc.2022.819905 -
Primary Mucosal Melanoma: Clinical Experience from a Single Italian Center.
Falcone R, Verkhovskaia S, Di Pietro FR, Poti G, et al · · 2024 · cited 5× · PMID 38275835 · DOI 10.3390/curroncol31010042
Verify or expand the search:
- PubMed search for NCT05009446
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT05011227 — Camrelizumab and Chemotherapy Combined With Endoscopic Surgery for Recurrent Nasopharyngeal Carcinoma · Phase 2 · unknown
- NCT05614375 — Endoscopic Surgery in the Treatment of Soft Tissue Sarcoma in Nasal and Paranasal Sinus · recruiting
Other recruiting trials for Mucosal Melanoma
Currently open trials in the same condition.
- NCT06319196 — Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma · Phase 2 · recruiting
- NCT07400302 — Sintilimab Combined With Chemotherapy for Adjuvant Treatment of Mucosal Melanoma After Surgery · Phase 2 · recruiting
- NCT05111574 — Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery · Phase 2 · recruiting
- NCT05086692 — A Beta-only IL-2 ImmunoTherapY Study · Phase 1, PHASE2 · recruiting
- NCT04645680 — Diet and Immune Effects Trial: DIET- A Randomized Double Blinded Dietary Intervention Study in Patients With Metastatic · Phase 2 · active not recruiting
Other Eye & ENT Hospital of Fudan University trials
Trials by the same sponsor.
- NCT07522879 — A Study of Becotatug Vedotin (MRG003) Combined With Epirubicin as Neoadjuvant Therapy for EGFR-Positive, Unresectable Re · Phase 2 · not yet recruiting
- NCT07563088 — SPARE-1st: Surgery Alone vs Surgery Plus Postoperative Radiotherapy for Sinonasal Adenoid Cystic Carcinoma · not yet recruiting
- NCT07575334 — Acupuncture Therapy for Sudden Sensorineural Hearing Loss · NA · recruiting
- NCT07320508 — Epirubicin Interventional Chemotherapy for Sinonasal Adenoid Cystic Carcinoma (SNACC): A Prospective Study · Phase 2 · recruiting
- NCT07315802 — New Pattern of Retinal Laser Treatment for PDR · NA · 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 NCT05009446 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Eye & ENT Hospital of Fudan University
- Last refreshed: 17 August 2021
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/NCT05009446.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing