Head and Neck Squamous Cell Carcinoma Clinical Trial
Official title:
A Phase II Clinical Study to Evaluate the Efficacy and Safety of SIBP-03 Injection Combined With Cetuximab in Patients With Recurrent/Metastatic Advanced Head and Neck Squamous Cell Carcinoma (Non-nasopharyngeal Carcinoma)
This phase II study will be conducted in two parts at the same time, with a 21-day treatment cycle until disease progression, intolerable toxicity, withdrawal of informed consent, death, initiation of new anti-tumor treatment or loss of follow-up.
The participants in both study parts are the same, both of whom were patients with recurrent/metastatic advanced HNSCC (non nasopharyngeal carcinoma). Part one is a one-arm, open-ended study. First, 3 subjects were treated with SIBP-03 15mg/kg every 3 weeks (Q3W) combined with cetuximab every week (QW). If 1/3 subjects (1 case) have DLT, 3 more subjects need to continue to observe the safety and tolerance; If DLT occurs in 3 cases or ≥ 2 cases in 6 cases, the sponsor and the researcher will discuss and decide whether to terminate this part of the study or change the dose. 12 subjects were added at most. Part two is a randomized, double-blind study. Including a trial group and a placebo control group. The qualified subjects in this stage will be randomly assigned according to the ratio of 2: 1, including 38 cases in the experimental group and 19 cases in the control group, with a total of 57 subjects. Randomization was stratified according to ECOG scores (0 and 1) and stages (non-stage IV and stage IV). ;
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