Last reviewed · How we verify
NCT07320690: Neo-Margin
De-Escalation Surgery After Immunotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma
Phase 3 trial testing De-escalation surgery in Squamous Cell Carcinoma of the Head and Neck in 356 participants. Not yet recruiting.
1 July 2031
Quick facts
| Lead sponsor | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
|---|---|
| Phase | Phase 3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 356 |
| Start date | 1 January 2026 |
| Primary completion | 1 July 2031 |
| Estimated completion | 1 July 2031 |
| Sites | 1 location across China |
Drugs / interventions tested
- De-escalation surgery
- Standard Surgery
- radiotherapy — full drug profile →
- adjuvant immunotherapy — full drug profile →
Conditions studied
- Squamous Cell Carcinoma of the Head and Neck — all drugs for Squamous Cell Carcinoma of the Head and Neck →
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Who can join
Adults 18 to 75, any sex, with Squamous Cell Carcinoma of the Head and Neck. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicenter, randomized, open-label, non-inferiority clinical trial designed to evaluate whether downgraded surgery-guided by post-immunotherapy tumor boundaries-can achieve comparable 3-year overall survival (OS) to standard surgery in patients with Stage III-IVa locally advanced head and neck squamous cell carcinoma (HNSCC) who have responded to neoadjuvant immunotherapy. A total of 356 patients will be randomized 1:1 to receive either downgraded or standard surgery, followed by risk-adapted adjuvant therapy. The primary endpoint is 3-year OS, with secondary endpoints including disease-free survival, quality of life, complication rates, and cost-effectiveness. The study hypothesizes that downgraded surgery will preserve organ function and quality of life without compromising survival outcomes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07320690
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Squamous Cell Carcinoma of the Head and Neck
Currently open trials in the same condition.
- NCT07465276 — Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC · Phase 2 · recruiting
- NCT06736379 — Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer · Phase 1 · recruiting
- NCT06223568 — Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subject · Phase 2 · recruiting
- NCT05983133 — A Study of PF-08046052/SGN-EGFRd2 in Advanced Solid Tumors · Phase 1 · active not recruiting
- NCT05208762 — A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors · Phase 1 · recruiting
Other Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University trials
Trials by the same sponsor.
- NCT07535567 — Postoperative Radiotherapy With Nimotuzumab ± Benmelstobart in Intermediate-Risk Head and Neck Squamous Cell Carcinoma: · Phase 2, PHASE3 · not yet recruiting
- NCT07505251 — Development and Validation of the Periodontal Map Derived From IOS and CBCT Registration for Diagnosis and Treatment Pla · not yet recruiting
- NCT07466810 — Resection and Defect Repair of Oral Cancer Aided by Mixed Reality Technology · NA · not yet recruiting
- NCT07533695 — Impact of Day 2 Versus Day 3 Fresh Embryo Transfer on Live Birth Rate in Poor-Prognosis Patients · NA · not yet recruiting
- NCT07490561 — The Impact of Assisted Hatching on Pregnancy Outcomes After Vitrified-Warmed Embryo Transfer in Advanced-age Patients · 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 NCT07320690 (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 Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Last refreshed: 6 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/NCT07320690.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing