The purpose of this study is to evaluate the effectiveness and safety of the combination therapy of immunotherapy (Sintilimab) with targeted therapy (Cetuximab) as a possible treatment before and after surgery for locally advanced oral/pharyngeal squamous cell carcinoma.
Participants must have histologically or cytologically confirmed oral/oropharyngeal squamous cell carcinoma (including tongue, lips, gums, cheeks, floor of mouth, hard palate, soft palate, posterior molar area, lateral pharyngeal wall, posterior pharyngeal wall, tonsils). PD-L1 expression score (CPS score) >1
Participants must diagnosed with clinical staging III or IVa (AJCC, 8th edition), without evidence of distant metastasis (M0) based on PET/CT or chest, abdominal and pelvic CT scans, and standard treatment is recommended, including surgical resection and adjuvant radiotherapy+/- chemotherapy.
Age ranges from 18 to 75 years old
ECOG performance status 0 or 1.
Squamous cell carcinoma with primary site of nasopharynx or skin.
Diagnosed with malignant diseases other than head and neck squamous cell carcinoma within 3 years before the first administration (excluding Radical treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curative excised carcinoma in situ)
Has received therapy treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-CTLA-4 antibody (or any other antibody acting on T cell co stimulatory or checkpoint pathways).
Has received live or attenuated vaccines within 30 days prior to the first dose of Sintilimab, inactivated vaccines are allowed.
Single group
Sintilimab+Cetuximab
DrugNeoadjuvant treatment: the participants will receive Sintilimab 200 mg (each 3-week/cycle) and Cetuximab (400 mg/m2 first time and followed 250 mg/m2, day 1, day 8, day 15) for 2 cycles. Adjuvant treatment: the participants will receive Sintilimab 200 mg (each 3-week cycle, a total of 17 cycle) for a total of one year.
Rate of Major Pathological Response (mPR)
Major pathologic response (mPR) is defined as having ≤ 10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes as assessed by pathologists. Rate is the proportion of treated participants who experienced mPR
Rate of Pathologic complete response (pCR)
Pathologic complete response (PCR) is defined as having no invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes as assessed by pathologists. Rate is the proportion of treated participants who experienced PCR.
2 year Event-free Survival (EFS) Rate
EFS is the time from the date of study entry to the date of first record of disease progression as defined by RECIST 1.1
2 year Overall Survival (OS) Rate
OS is the time from study entry to death due to any cause
Adverse Events (AEs)
Number of participants experiencing any sign, symptom, disease, or worsening of preexisting conditions temporally associated with the experimental interventions or irrespective of the experimental interventions
Changes in the Level of biomarkers for predicting therapeutic efficacy
Changes in the Level of PD-L1 expression, tumor mutation burden, microsatellite instability, immune cell invasion
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