Toripalimab Combined With Gemcitabine and Cisplatin Treating Resectable Locally Advanced HNSCC
Status:
Recruiting
Trial end date:
2026-01-15
Target enrollment:
Participant gender:
Summary
Head and Neck Squamous Cell Carcinoma (HNSCC) is the most common malignant tumor of the head
and neck, accounting for 90% of head and neck malignancies, and 16% to 40% of systemic
malignancies. There are 60,000 new cases reported annually worldwide, and the incidence and
mortality are increasing year by year, however,the 5-year survival rate under standard
treatment is only 50%. 70%~80% of patients already developed into locally advanced status
(stage II-IVa) when they are first diagnosed. The treatment principle is mainly determined by
the clinical stage and location of the tumor, various factors affecting the prognosis and the
patient's tolerance. Locally advanced head and neck squamous cell carcinoma has a higher
probability of local/regional failure and distant metastasis after treatment. Therefore, in
recent years, the use of neoadjuvant therapy (NAC) followed by surgery or radiotherapy has
been advocated. Surgical treatment is still one of the preferred treatments for local head
and neck squamous cell carcinoma. TPF (Docetaxel + Cisplatin + Fluorouracil) regimen is
considered as the standard regimen of induced chemotherapy for head and neck squamous cell
carcinoma (especially in laryngeal cancer), which can significantly reduce the patient's
distant metastasis rate and prolong overall survival ( OS). Nevertheless, the therapeutic
effect of neoadjuvant therapy on head and neck squamous cell carcinoma has reached a
bottleneck. In recent years, PD-1 inhibitors have achieved significant effects in the field
of tumor therapy and have been approved for the treatment of various tumors including head
and neck tumors. And a number of clinical trials have shown that PD-1 inhibitors can
significantly prolong the OS of patients.
Altogether, the investigators launch an open-label, single-arm, phase Ib clinical trial of
PD-1 inhibitor plus chemotherapy in patients with resectable HNSCC to explore the safety and
efficacy of the treatment. The study comprises two stages, run-in and case development.