CRIA: Phase II Trial of Induction and Adjuvant Camrelizumab Combined with Chemoradiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma

Abstract

<h3>Purpose/Objective(s)</h3> Locally advanced head and neck squamous cell carcinoma (HNSCC) is still characterized by poor prognosis despite concurrent chemoradiotherapy as the current standard of care. Current evidence from Phase II clinical trial indicated that immune checkpoint inhibitor (ICI) barely improved response when concurrently combined with chemoradiotherapy. We aimed to assess the efficacy and safety of sequential anti-PD-1 therapy and concurrent chemoradiotherapy in locally advanced HNSCC. <h3>Materials/Methods</h3> The study is a single-center, Phase II, single-arm clinical trial. Patients with inoperable stage III∼ IVb HNSCC are eligible, regardless of PD-L1 or p16 status. This trial planned to enroll approximately 30 patients. In initial lead-in phase, all participants will receive induction camrelizumab (anti-PD-1 therapy) at least one cycle (200mg intravenously every 3 weeks) with or without induction chemotherapy. Definitive concurrent chemoradiotherapy will consist of intensity-modulated radiotherapy (70 Gy/35 fractions/7 weeks) with concurrent cisplatin chemotherapy (40 mg/m² every week for 6 cycles). After 4∼6 weeks of the completion of radiotherapy, adjuvant camrelizumab therapy will begin every 3 weeks for 16 cycles (1 year) or continue until progression or unacceptable toxicity. The primary endpoints are minimal residual disease (MRD) for relapse prediction, 2-year progression free survival (PFS), using RECIST 1.1 criteria. The secondary objectives are objective response rate (ORR), disease control rate (DCR), 2-year overall survival (OS), adverse events of grade 3-4 or higher, quality of life. As of January 2022, 6.7% of the planned 30 subjects have been enrolled. ClinicalTrials.gov Identifier: NCT05213884. <h3>Results</h3> Clinical trial in progress. <h3>Conclusion</h3> Clinical trial in progress.