Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07209189 | Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-escalation (NeoScorch HN) | PHASE2 | RECRUITING | 75 | — | — | Feb 18, 2026 | Dec 1, 2030 | Apr 23, 2026 | 1 | United States |
The objective is to achieve high-quality or "deep" responses to treatment (measurable pathologic response, MPR) that are sufficient to enable surgical de-escalation (less extensive surgery) or response-adaptive, function-preserving surgery (tailoring the surgical approach to preserve organ structure and function while maintaining oncologic safety).
| Arm | Type | Description |
|---|---|---|
| Neo + Surg : Neoadjuvant Treatment and surgery | EXPERIMENTAL | Neoadjuvant Chemotherapy with * Toripalimab + Cisplatin + Docetaxel OR * Toripalimab + Carboplatin + Docetaxel |
| Rad+/-Chem : Adjuvant radiation or chemoradiotherapy | EXPERIMENTAL | Radiation or Chemotherapy will be given after the surgery |
| Adjuvant (ADJ) treatment | EXPERIMENTAL | Treated with Toripalimab after adjuvant treatment |
| Name | Type | Description |
|---|---|---|
| Toripalimab + Chemotherapy | DRUG | Toripalimab is the study drug and will be given via IV in all arms except "Rad+/-Chem : Adjuvant radiation or chemoradiotherapy" |
| Toripalimab | DRUG | Study drug |
| Chemoradiotherapy or radiation | RADIATION | In the adjuvant phase, either radiation or chemoradiotherapy is used for treatment |
Inclusion: * Eligible subjects must have histologically confirmed, locoregionally advanced head and neck or sinonasal, nasolacrimal, or skull base tumors and meet HPV testing requirements as outlined. * HPV-independent HNSCC (cT2-cT4, N0-N3) with potential for organ preservation using response-adap...