Clinical Trial

Lattice-Based Radiotherapy and Chemoimmunotherapy for Oropharyngeal Squamous Cell Carcinoma

Not Yet Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
This single-arm Phase I/II trial evaluates induction chemoimmunotherapy combined with lattice radiotherapy (LRT) in patients with non-low risk oropharyngeal squamous cell carcinoma and primary tumor ≥3 cm or primary tumor and pathologic lymph node ≥3 cm in longest dimension. BOIN12 adaptive dose-finding will guide dose across two anatomical cohorts-primary-tumor only (P) and primary + largest involved node (PN)-with a total target accrual of about 60 evaluable patients. Dose-limiting toxicity is monitored separately in each cohort. If both tolerate the same dose, that unified optimal biological dose (OBD) advances to Phase II; if tolerability differs, the PN-specific OBD expands while the P cohort is analyzed descriptively. After induction, imaging determines response: patients achieving ≥50% volumetric tumor shrinkage receive hypofractionated chemoradiation, whereas those with \<50% shrinkage are treated with conventional fractionation, personalizing definitive therapy according to early safety and efficacy signals.
Trial Details
NCT Number NCT07428148
Lead Sponsor NYU Langone Health
Conditions Oropharyngeal Squamous Cell Carcinoma
Enrollment 60 participants
Start Date 2026-05
Primary Completion 2031-05 (estimated)
Study Completion 2033-05 (estimated)
Updated on ClinicalTrials.gov 2026-02-23