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

NCT06673693 | Recruiting Phase 2 DMC

• 1 other identifier: 2024-FXY-179
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC); HNSCC

Keywords

SBRT; PD-1 antibody; Tislelizumab; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with MPR

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

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

Secondary Outcomes (6)

• Number of Participants with pCR

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

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

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

• Median Progression-Free Survival

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

• Median Overall Survival

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

• Safety

  From the commencement of neoadjuvant therapy until 30 days post-completion

Study Arms (1)

SBRT combined with PD-1

EXPERIMENTAL

Week 1: SBRT radiation therapy administered as 24Gy/3f, on days 1, 3, and 5. Weeks 2-5: Tislelizumab 200mg intravenous drip every 3 weeks, for a total of two cycles.

Drug: Tislelizumab

Interventions

Tislelizumab DRUG

SBRT

Also known as: Radiotherapy

SBRT combined with PD-1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Ages 18 to 70
• The primary organ functions meet the test requirements
• Patients participate voluntarily and sign informed consent forms

You may not qualify if:

• 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
• The patient also has a serious, uncontrolled illness
• Heart, brain, lung and other important organ function abnormal. Patients with hypertension (systolic blood pressure \>140 mmHg, diastolic blood pressure \>90 mmHg) who cannot be reduced to the normal range by antihypertensive drugs have grade I or above myocardial ischemia or myocardial infarction, arrhythmia, and grade II cardiac insufficiency; Abnormal coagulation function (INR \>1.5 or prothrombin time (PT) \> ULN+4 seconds or APTT \>1.5 ULN), have a tendency to bleed or are receiving thrombolytic or anticoagulant therapy; Have a definite bleeding tendency; Patients with positive urinary protein (urinary protein test 2+ or more, or 24-hour urinary protein quantification \>1.0g)
• Glucocorticoid therapy for 30 days prior to initial administration (prednisone equivalent dose \> 10mg daily); Have an active autoimmune disease that has required systemic treatment (i.e., disease-modulating drugs, corticosteroids, or immunosuppressive drugs) in the last 2 years
• History of non-infectious pneumonia requiring corticosteroid treatment within 1 year prior to the first dose administration or current presence of interstitial lung disease
• Active infections such as tuberculosis that require systemic treatment
• A known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive)
• Patients who have a history of psychotropic substance abuse and cannot abstain or have mental disorders
• The investigator determines other circumstances that may affect the conduct of the clinical study and the determination of the study results
• While participating in another therapeutic clinical study

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (2)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

NOT YET RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

tislelizumab; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Chun-Yan Chen

CONTACT

13826423812; chenchuny@sysucc.org.cn

Ya-Ni Zhang

CONTACT

15914271501; zhangyn1@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 5, 2024
• Study Start: April 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)