Phase II Study of Nimotuzumab, Toripalimab, and Chemotherapy for Treating Locally Advanced Tonsillar Cancer

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining nimotuzumab, toripalimab, and chemotherapy to treat patients with locally advanced tonsillar cancer. This prospective, single-arm Phase II study aims to see if this combination can improve the pathological complete response rate and overall survival compared to historical data. Approximately 10 patients will be enrolled with a follow-up period extending up to five years after enrollment to monitor long-term outcomes. Participants receive nimotuzumab 400 mg, toripalimab 240 mg, nab-paclitaxel 260 mgm, and carboplatin through intravenous infusions every three weeks for 2 to 4 cycles. Each infusion lasts at least 60 minutes with careful monitoring for reactions. After 2 to 4 cycles of this neoadjuvant combination therapy, patients undergo endoscopy and imaging evaluation around day 42 to assess response. Throughout the study, participants will have assessments including pathological examination within 1 to 2 weeks after radical surgery to measure the pathological complete response rate, surgical margins, and major pathological response. Radiological response rates are evaluated after completing two treatment cycles, and functional status is assessed before surgery and at 1 month, 6 months, and 1 year post-surgery or concurrent chemoradiotherapy. Disease-free survival will be followed for up to 72 months. Participants must comply with study procedures and follow-up visits during this period.

Nimotuzumab Combined With Toripalimab and Chemotherapy for Locally Advanced Tonsillar Cancer