RecruitingPhase 2NCT07055841

Single-Arm Exploratory Study of PD-L1 Antibody Plus Neoadjuvant Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma


Sponsor

Xiuping Ding

Enrollment

69 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This trial explores adding a PD-L1 immunotherapy drug to standard chemotherapy before surgery in patients with locally advanced head and neck squamous cell cancer (cancers of the mouth, throat, or voice box). By combining immunotherapy with chemotherapy before surgery, researchers hope to shrink the tumor more effectively and improve outcomes. **You may be eligible if...** - You have been diagnosed with stage III–IVB head and neck squamous cell cancer confirmed by biopsy - You have not yet received any treatment for this cancer - Your general health is good (ECOG 0–1) and you are expected to survive at least 12 weeks - Your blood counts and organ function meet minimum requirements - You agree to use contraception if you are of childbearing potential **You may NOT be eligible if...** - You have already received chemotherapy or radiation for this cancer - You have an active autoimmune disease - You have severe organ dysfunction - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdebrelimab

1200mg, intravenous infusion, D1, Every three weeks, there are two cycles in total.

DRUGTP 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.

PROCEDURESurgery or radiotherapy

Surgery or radiotherapy should be performed 1-4 weeks after the completion of neoadjuvant therapy.


Locations(1)

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

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NCT07055841


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