Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT06728618
Brief Summary:
The purpose of this study is to evaluate the effectiveness and safety of the combination therapy of immunotherapy (Tislelizumab), targeted therapy (Cetuximab), with chemotherapy (Cisplatin and Nab-paclitaxel) as a possible treatment before and after salvage surgery for locally recurrent oral/pharyngeal squamous cell carcinoma. The combination of Tislelizumab，Cetuximab, Cisplatin and Nab-paclitaxel will be given prior to your surgery, while Tislelizumab and Cetuximab will be continued for approximately half a year after surgery.
Detailed Description:
Despite multimodality curative approaches to treat patients with oral/oropharyngeal squamous cell carcinoma (OSCC), approximately 30-40% of patients recur locally. Recurrent OSCC contributes to significant morbidity and portends overall poor survival, reflecting a situation that is difficult to treat owing to the effects of prior therapy (surgery, radiation, and/or chemotherapy) on the delicate structures of the head and neck. Both the NCCN and the CSCO head and neck cancer treatment guidelines recommend salvage surgery as a Grade I recommended curative treatment method whenever possible, as this has been shown to have a significantly better outcome as compared to patients treated non-surgically with radiation therapy with or without concurrent chemotherapy. However, salvage surgery is extremely challenging due to delicate structures of the head and neck.
Previous studies have recommended that the combination of targeted therapy (cetuximab) and chemotherapy (cisplatin, paclitaxel) has effective anti-tumor effects for recurrent/metastatic head and neck squamous cell carcinoma. Recently, newer approaches also have shown favorable safety and evidence of pathologic response when using immune-checkpoint inhibitors as neoadjuvant therapy prior to upfront, curative-intent surgery in resectable head and neck cancer. Immunotherapy is expected to be more effective with smaller amounts of disease and application of therapy when disease burden is minimal is expected to yield improved outcomes. Locally recurrent patients undergoing salvage therapy are understudied and deserves further exploration.
This is a prospective, open label, single arm, phase II, single center interventional study of neoadjuvant combination therapy of immunotherapy (Tislelizumab), targeted therapy (cetuximab), with chemotherapy (cisplatin and nab-paclitaxel) followed by salvage surgery and followed by adjuvant immunotherapy (Tislelizumab), targeted therapy (cetuximab) in patients with resectable recurrent oral/oropharyngeal squamous cell carcinoma.
Study:
NCT06728618
Study Brief:
Protocol Section:
NCT06728618