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**INGN 201 + cisplatin + fluorouracil** is a combination regimen used in investigational therapy for advanced head and neck cancers, notably squamous cell carcinoma. INGN 201 (also known as Advexin, Ad5CMV-p53, or adenoviral p53 gene therapy) is a recombinant adenoviral vector carrying the wild-type p53 tumor suppressor gene. INGN 201 functions by delivering the p53 gene to tumor cells to restore p53-dependent apoptosis and cell cycle regulation, counteracting the common p53 mutations present in many cancers. Cisplatin is a platinum-based chemotherapy that causes DNA crosslinking, leading to apoptosis. Fluorouracil is a pyrimidine analog that inhibits thymidylate synthase, impeding DNA synthesis. In this combination regimen, INGN 201 aims to sensitize tumor cells to the cytotoxic effects of chemoradiotherapy, potentially improving local control and reducing recurrence after surgery. This combination has been evaluated in clinical trials for advanced, resectable squamous cell carcinoma of the oral cavity, oropharynx, larynx, and hypopharynx, typically as perioperative gene therapy followed by conventional chemoradiotherapy[1][2][3].
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