Actively Recruiting
Single-Arm Exploratory Study of PD-L1 Antibody Plus Neoadjuvant Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma
Led by Xiuping Ding · Updated on 2025-07-09
69
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This single-arm exploratory study plans to enroll 69 locally advanced head and neck squamous cell carcinoma (LA-HNSCC) patients. Participants will receive Adebrelimab (PD-L1 antibody) plus TP regimen (docetaxel/cisplatin) as neoadjuvant therapy for 1-4 weeks, followed by surgery and subsequent follow-up phase.
CONDITIONS
Official Title
Single-Arm Exploratory Study of PD-L1 Antibody Plus Neoadjuvant Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with head and neck squamous cell carcinoma by histology or cytology
- No prior systemic treatment for head and neck squamous cell carcinoma
- Cancer stage III to IVB according to AJCC TNM staging system
- ECOG performance status score of 0 to 1
- Expected survival of at least 12 weeks
- Adequate organ function with blood counts, liver, and kidney function within specified limits
- Use of medically approved contraception during treatment and for 6 months after last dose for patients of reproductive potential
- Voluntary participation with signed informed consent and ability to comply with study requirements
You will not qualify if you...
- Uncontrollable pleural, pericardial, or peritoneal effusion requiring repeated drainage
- History of allergy to Adebrelimab components
- Recent treatments including other investigational drugs within 4 weeks, anti-tumor therapies within 2 weeks, or corticosteroids above specified doses within 2 weeks
- Participation in other interventional clinical trials except observational studies
- Previous treatment with paclitaxel drugs
- Unresolved toxicity from prior anti-tumor treatments above Grade 1
- Active or history of autoimmune diseases except stable conditions as specified
- Immune deficiencies including HIV positive, organ or bone marrow transplantation, active hepatitis beyond specified limits
- Uncontrolled cardiovascular diseases or symptoms
- Recent severe infection or active pulmonary inflammation
- History of interstitial lung disease or active pulmonary tuberculosis infection
- Diagnosis of other malignant tumors within 5 years except low-risk treated cancers
- Pregnant or lactating women
- Other serious illnesses or social factors that may affect safety or study compliance
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250117
Actively Recruiting
Research Team
X
Xiuping Ding, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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