This study aims to explore the optimal course of neoadjuvant immunotherapy for HNSCC by comparing the efficacy and safety of 4 cycles and 2 cycles of neoadjuvant tislelizumab combined with chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Tislelizumab: 200mg, day 1, every 3 weeks for 4 cycles Cisplatin: 75mg/m\^2 Nab-paclitaxel: 260mg/m\^2
Tislelizumab: 200mg, day 1, every 3 weeks for 2 cycles Cisplatin: 75mg/m\^2 Nab-paclitaxel: 260mg/m\^2
Pathological Complete Response (pCR)
Pathological complete response (pCR) is defined as having no residual invasive squamous cell carcinoma within the resected primary tumor specimen.
Time frame: 6 months
Major Pathological Response (mPR)
The percentage of participants with a major pathological response (mPR) is defined as ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen.
Time frame: 6 months
Organ perservation rate
Organ perservation rate defined as the proportion of patients who successfully preserved their organs and functions through neoadjuvant treatment.
Time frame: 6 months
Operation delay rate
Operation delay rate defined as any change to scheduled surgery date considered to be at least possibly related to neoadjuvant treatment.
Time frame: 6 months
Objective resopnse rate (ORR)
ORR defined as the proportion of all subjects who achieved complete response (CR) or partial response (PR) as assessed by RECIST V1.1 after the end of neoadjuvant therapy
Time frame: 6 months
Event-free Survival (EFS)
EFS is the time from the date of randomization to the date of first record of any of the following events: radiographic disease progression; local or distant progression or recurrence as assessed with imaging or biopsy as indicated; or death due to any cause.
Time frame: 3 years
Overall Survival (OS)
OS is the time from randomization to death due to any cause.
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Time frame: 3 years
Percentage of adverse events graded by CTCAE v5.0
Percentage of adverse events that are possibly, probably or definitely related to study treatment per Criteria for Adverse Events version 5 (CTCAE v5.0).
Time frame: 3 years
Change From Baseline in Quality of Life Scale (QoL) (EORTC QLQ-C30) items 30
Change from baseline in the combined score of quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) items 30
Time frame: 3 years
Change From Baseline in Quality of Life Scale (QoL) EOTRC QLQ -H&N 35
Change from baseline in the combined score of quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire EOTRC QLQ -H\&N 35
Time frame: 3 years