Spots Global Cancer Trial Database for Toripalimab in Combined With Cetuximab，Chemotherapy for Conversion Therapy of Locally Nonresectable OCSCC

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Trial Identification

Brief Title: Toripalimab in Combined With Cetuximab，Chemotherapy for Conversion Therapy of Locally Nonresectable OCSCC

Official Title: Toripalimab in Combination With Cetuximab，Cisplatin and 5-FU for Conversion Therapy of Locally Nonresectable Oral Cavity Squamous Cell Carcinoma （OCSCC）

Study ID: NCT06081582

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Toripalimab

Study Description

Brief Summary: This is a prospective, single center phase II clinical study with a planned enrollment of 33 patients. The main objective is to evaluate the efficacy and safety of the PD-1 inhibitor toripalimab combined with cetuximab, cisplatin, and 5-FU regimen in the treatment of locally advanced oral squamous cell carcinoma patients who are initially unresectable.

Detailed Description: In the past decade, the treatment plan for non-surgical locally advanced HNSCC patients who are suitable for receiving synchronous radiotherapy and chemotherapy has remained unchanged, and innovative treatment methods are urgently needed. Based on the above research, immunotherapy combined with chemotherapy and immunotherapy combined with cetuximab have good efficacy and safety in non-surgical HNSCC patients. Therefore, combining PD-L1 antibodies with chemotherapy, surgery to further improve the efficacy of comprehensive treatment may become a new direction in tumor treatment. The achievement of pCR or MPR in conversion therapy is related to better OS and DFS outcomes in patients. In the era of immunotherapy, conversion therapy centered around surgery has become a hot topic in the field of treatment for locally advanced oral squamous cell carcinoma that cannot be surgically removed upon initial diagnosis. There is no particularly preferred standard conversion chemotherapy regimen for patients with locally advanced head and neck squamous cell carcinoma that cannot be surgically removed initially. The combination of PD-1 inhibitor toripalimab, cetuximab, and chemotherapy may benefit the efficacy of these patients. Therefore, this prospective phase II clinical trial was designed to evaluate the efficacy and safety of PD-1 inhibitor toripalimab combined with chemotherapy and cetuximab conversion therapy in locally advanced oral squamous cell carcinoma patients who were initially unresectable.