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Tislelizumab Combined With SBRT for the Treatment of Head and Neck Squamous Cell Carcinoma

ConditionsHead and Neck Squamous Cell Carcinoma (HNSCC)HNSCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University

About this trial

Exploring the efficacy and safety of Tislelizumab combined with stereotactic body radiation therapy (SBRT) as neoadjuvant treatment for locally advanced head and neck squamous cell carcinoma (HNSCC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically confirmed, initially treated, surgically resectable head and neck squamous cell carcinoma.

Clinical stage III to IVB (AJCC 8th edition), except HPV-positive oropharyngeal cancer

Following multidisciplinary discussions involving otolaryngologists and radiation oncologists, the assessment concluded that the tumor is resectable or marginally resectable and suitable for preoperative SBRT

Karnofsky Performance Status score ≥ 70

Disqualifiers

Patients previously treated with head and neck surgery were excluded from diagnostic biopsies of primary and regional lymph nodes

Previous chemotherapy for any reason, or radiotherapy in the head and neck area, or molecular targeted drug therapy; Previously received anti-PD-1, anti-PD-L1, anti-PD-L2 and other drugs or drugs acting on another irritating or co-inhibitory T cell receptor (such as CTLA-4, OX 40, CD137) treatment, or cell biotherapy

Pregnant or lactating women

Have had or co-had other malignancies

Trial design

Design model

Single group

Treatments tested in this trial

  • Tislelizumab

    Drug

    SBRT

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: SBRT combined with PD-1Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with MPR

MPR is defined as \< 10% of surviving tumor cells.

Time frame
From date of first day until the date of obtaining postoperative pathology, assessed up to 4 months

Secondary outcomes

1

Number of Participants with pCR

pCR is defined as the absence of viable tumor cells in the postoperative specimen.

Time frame
From date of first day until the date of obtaining postoperative pathology, assessed up to 4 months
2

Number of Participants with downstaging in Clinical Pathological Staging as assessed by the AJCC 8th Edition Staging System

Utilization of the AJCC 8th Edition Staging System for Downstaging from Clinical to Pathological Staging

Time frame
From date of first day until the date of obtaining postoperative pathology, assessed up to 4 months
3

Median Progression-Free Survival

The time corresponding to a cumulative progression-free survival rate of 50%

Time frame
The time corresponding to a cumulative progression-free survival rate of 50%
4

Median Overall Survival

The time corresponding to a cumulative overall survival rate of 50%. Survival rate is defined as the time from the initiation of the first treatment to death from any cause.

Time frame
The time corresponding to a cumulative overall survival rate of 50%

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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