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NOT YET RECRUITING
NCT07778732
PHASE2

Adebrelimab Combined With Dalpiciclib Isethionate Plus Chemotherapy for Neoadjuvant Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

This single-center, open-label Phase II trial aims to evaluate the efficacy and safety of neoadjuvant combination therapy with Adebrelimab (anti-PD-L1), Dalpiciclib Isethionate (CDK4/6 inhibitor), and cisplatin chemotherapy in patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC). A total of 32 eligible subjects will receive 2 cycles of triplet neoadjuvant treatment prior to radical surgery. The primary endpoint is the pathological complete response (pCR) rate following neoadjuvant therapy; secondary endpoints include major pathological response (MPR), objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), 1-year overall survival (1y-OS), and treatment-related adverse events (TRAEs). The exploratory objectives analyze correlations between biomarkers (oral microbiome, CDKN2A/B deletion, CDK4/6 amplification, and PD-L1 expression) and therapeutic efficacy or prognosis. Subjects will receive long-term tumor and survival follow-up after surgery until disease progression, death, loss to follow-up, or the end of study.

Official title: A Prospective, Open-Label, Phase II Clinical Trial of Adebrelimab Combined With Dalpiciclib Isethionate Plus Chemotherapy for Neoadjuvant Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2026-09-01

Completion Date

2028-09-01

Last Updated

2026-08-21

Healthy Volunteers

No

Conditions

Interventions

DRUG

Adebrelimab Injection

Dose: 1200 mg Route: Intravenous Infusion Schedule: Day 1 of each 21-day cycle, every 3 weeks for 2 cycles total Description: Intravenous infusion over 30 minutes (20-60 min window), no dose reduction allowed; suspend or permanently discontinue per immune-related adverse events.

DRUG

Dalpiciclib Isethionate

100mg/125mg, Schedule: Days 1-21 of every 28-day cycle, continuous oral administration Description: Dose modification per CTCAE v5.0 toxicity grading; permanent discontinuation for ≥2 grade interstitial lung disease, grade 4 hepatotoxicity.

DRUG

Cisplatin

Dose: 75 mg/m² Route: Intravenous drip Schedule: Day 1 of each 21-day cycle, every 3 weeks for 2 cycles total Description: Dose reduced to 40mg/m² if creatinine clearance 40-50 mL/min; discontinue cisplatin if CrCl \<40 mL/min; 20% dose reduction for grade 3-4 related toxicities.

PROCEDURE

Radical Surgical Resection

Timing: 4-6 weeks after completion of 2 neoadjuvant cycles Description: Curative surgical resection of primary tumor and regional lymph nodes per standard head and neck oncology guidelines.