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
Study ID
NCT07778732
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adebrelimab Injection — DRUG
    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.
  • Dalpiciclib Isethionate — DRUG
    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.
  • Cisplatin — DRUG
    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.
  • Radical Surgical Resection — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Aug 21, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Jun 1, 2027
Completion
Sep 1, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant Triplet Combination Therapy Arm

Primary Outcome Measure

Pathological Complete Response (pCR) Rate [ Time Frame: At time of surgical resection (approximately 6 weeks after 2 cycles neoadjuvant treatment) ]

Central Contacts

Find similar trials

Nationwide
Head and neck cancer trialsOncology trialsENT trials

Related Studies