Single-Arm Exploratory Study of PD-L1 Antibody Plus Neoadjuvant Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma
NCT07055841 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69
Last updated 2025-07-09
Summary
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
- Squamous Cell Carcinoma of Head and Neck
Interventions
- DRUG
-
Adebrelimab
1200mg, intravenous infusion, D1, Every three weeks, there are two cycles in total.
- DRUG
-
TP regimen
TP regimen: Docetaxel 75 mg/m2, intravenous infusion, D1, Cisplatin 75 mg/m2, intravenous infusion, D1, Every three weeks, there are two cycles in total.
- PROCEDURE
-
Surgery or radiotherapy
Surgery or radiotherapy should be performed 1-4 weeks after the completion of neoadjuvant therapy.
Sponsors & Collaborators
-
Xiuping Ding
lead OTHER
Principal Investigators
-
wanjun chen, physician · Shandong Cancer Hospital and Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-01
- Primary Completion
- 2025-08-01
- Completion
- 2026-08-01
Countries
- China
Study Locations
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