Lattice-Based Radiotherapy and Chemo-Immunotherapy for Oral Cavity Squamous Cell Carcinoma
Status:
NOT_YET_RECRUITING
Trial end date:
2031-03-01
Target enrollment:
Participant gender:
Summary
Single-arm, two-part, phase IB safety study that uses a Bayesian Optimal Interval (BOIN-12) dose-escalation scheme.
Part 1 (Dose Finding) - Sentinel start at 9 Gy 3 followed by fixed 3-patient BOIN cohorts exploring 8 Gy 3 9 Gy 3 10 Gy 3. Target DLT rate = 0.20; 7-15 participants.
Part 2 (Expansion) - Additional enrolment at the selected maximum tolerated dose (MTD) until 30 evaluable subjects (Parts 1 + 2 combined). Patients receive peaks to the primary tumor alone (Group A) or to the primary + involved nodes (Group B) at the investigators' discretion (non-random).
Surgery occurs 6-8 weeks after RT; adjuvant therapy is pathology-driven.