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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07214987 | PDT For Induction Therapy For Head And Neck Cancer | PHASE2 | NOT YET_RECRUITING | 26 | — | — | Mar 9, 2026 | Sep 1, 2029 | Jan 30, 2026 | 2 | United States |
Assessed using NCI Common Terminology for Adverse Event (CTCAE) version 5.0. The rate of patients with grade 3+ TRAEs-free during induction therapy will be summarized as a proportion with a corresponding exact 95% confidence interval (CI) (if the trial closes to accrual after the first stage), or a proportion with a corresponding 95% two-stage confidence interval (CI) if the trial closes to accrual after the second stage.
| Arm | Type | Description |
|---|---|---|
| PDT (cisplatin + docetaxel + toripalimab) induction therapy | EXPERIMENTAL | Toripalimab, cisplatin, and docetaxel will be given once every 21 days, +/- a window of 5 days, by intravenous infusion. On day 1 of each cycle, the pre-determined dose of toripalimab will be administered over about 60 minutes. The pre-determined dose of docetaxel will then be administered over about 1 hour. After docetaxel, the pre-determined dose of cisplatin will be administered over about 1-3 hours. This will continue for up to 3 cycles. Participants may be pre-medicated with drugs to reduce the chance of having a sensitivity reaction to the study treatment. The decision to pursue definitive chemoradiotherapy should be made by a multidisciplinary team specializing in treating head and neck cancers. For patients receiving chemoradiotherapy, the recommended concurrent chemotherapy regimen used with radiotherapy is weekly cisplatin. |
| Name | Type | Description |
|---|---|---|
| Toripalimab-tpzi | DRUG | Toripalimab-tpzi is a humanized IgG4 monoclonal antibody specific against human PD-1. |
| Cisplatin | DRUG | Cisplatin is an injectable chemotherapy agent classified as a platinum-based alkylating agent. |
| Docetaxel | DRUG | Docetaxel is a taxane chemotherapy agent. |
Inclusion Criteria: * Participants must have a new diagnosis of histologically or cytologically confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, sinonasal cavities or unknown primary HNSCC. * Participants with HPV-independent SCC or HNSCC or ...