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NCT07320690: Neo-Margin

De-Escalation Surgery After Immunotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma

Not yet recruiting Phase 3 Last updated 6 January 2026
What this trial tests

Phase 3 trial testing De-escalation surgery in Squamous Cell Carcinoma of the Head and Neck in 356 participants. Not yet recruiting.

Timeline
1 January 2026
Primary endpoint
1 July 2031
1 July 2031

Quick facts

Lead sponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
PhasePhase 3
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment356
Start date1 January 2026
Primary completion1 July 2031
Estimated completion1 July 2031
Sites1 location across China

Drugs / interventions tested

Conditions studied

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.

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Other recruiting trials for Squamous Cell Carcinoma of the Head and Neck

Currently open trials in the same condition.

Other Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University trials

Trials by the same sponsor.

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Data sources for this page

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.

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