Previous studies confirmed locally advanced oral/oropharyngeal squamous cell carcinoma (LA OSCC or OPSCC) patients with a pathological response had higher probability of survival in neoadjuvant settings. Several ongoing trials of neoadjuvant immunotherapy in head and neck cancer showed promising results. However, the optimal regimen remains unclear. This trial aimed to evaluate the efficacy and safety of neoadjuvant therapy with anti-programmed cell death 1 monoclonal antibody Tislelizumab and chemotherapy, followed by surgery and adjuvant radiotherapy or chemoradiotherapy plus Tislelizumab in LA OSCC or OPSCC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Dose: 200 mg Route: Intravenous infusion Frequency \& treatment mode: Day 1, every 3 weeks
Dose: 260 mg/m\^2 Route: Intravenous infusion Frequency \& treatment mode: Day 1, every 3 weeks
Dose: 60-75 mg/m\^2 Route: Intravenous infusion Frequency \& treatment mode: Day 1, every 3 weeks
Peking University School and Hospital Stomatology
Beijing, Beijing Municipality, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
Tangshan People's Hospital
Tangshan, Hebei, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Affiliated Hospital of Chifeng College
Chifeng, Inner Mongolia, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
The Hospital of Stomatology of Jilin University
Changchun, Jilin, China
China Medical University School and Hospital Of Stomatology
Shenyang, Liaoning, China
Shandong Provincial Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
...and 3 more locations
Rate of Event free survival (EFS) at 2 years
EFS is the time from the date of randomization to the date of first record of any of the following events: disease progression; local or distant recurrence as assessed with imaging or biopsy as indicated; or death due to any cause.
Time frame: Up to 2 years
Major Pathological Response (mPR)
The proportion of participants with a major pathological response (mPR) as assessed by the Central Pathologist at the time of definitive surgery. mPR is defined as ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all the sampled regional lymph nodes.
Time frame: Up to 30 days post-surgery
Pathological Complete Response (pCR)
Pathological complete response (pCR) is measured as the proportion of participants with a pathological complete response as assessed by the central pathologist at the time of definitive surgery. pCR is defined as having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes.
Time frame: Up to 30 days post-surgery
Overall response rate (ORR)
Overall response rate (ORR) is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.
Time frame: UP to 30 days prior-surgery
Overall survival (OS)
OS is the time from randomization to death due to any cause.
Time frame: Up to 2 years
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 per NCI-CTCAE V5.0.
Time frame: Up to 2 years
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