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

NCT07778732 | Not Yet Recruiting Phase 2

• 1 other identifier: HN-Neo-2026
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HNSCC

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR) Rate

  Percentage of subjects achieving pathological complete response in primary tumor and regional lymph nodes after neoadjuvant therapy (no viable tumor cells in surgical specimen)

  At time of surgical resection (approximately 6 weeks after 2 cycles neoadjuvant treatment)

Secondary Outcomes (6)

• Major Pathological Response (MPR) Rate

  At surgical resection

• Objective Response Rate (ORR)

  At the end of Cycle 2 (each neoadjuvant cycle is 28 days)

• Disease Control Rate (DCR)

  At the end of Cycle 2 (each neoadjuvant cycle is 28 days)

• Progression-Free Survival (PFS)

  Up to 36 months from enrollment

• 1-Year Overall Survival (1y-OS) Rate

  12 months post first treatment

Study Arms (1)

Neoadjuvant Triplet Combination Therapy Arm

EXPERIMENTAL

Drug: Adebrelimab Injection; Drug: Dalpiciclib Isethionate; Drug: Cisplatin; Procedure: Radical Surgical Resection

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.

Neoadjuvant Triplet Combination Therapy Arm

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.

Neoadjuvant Triplet Combination Therapy Arm

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.

Neoadjuvant Triplet Combination Therapy Arm

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.

Neoadjuvant Triplet Combination Therapy Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥18 years;
• Males or females who are not pregnant or breastfeeding;
• ECOG performance status of 0-1, with no deterioration within the past 7 days;
• Patients with histologically confirmed, locally advanced, resectable head and neck squamous cell carcinoma;
• Patients who have not previously received any systemic treatment regimens for this cancer type;
• Patients receiving neoadjuvant therapy must have evaluable lesions;
• Adequate organ and bone marrow function, with laboratory test results meeting the following requirements:
• HGB ≥ 90 g/L;
• NEUT ≥ 1.5 × 10⁹/L;
• PLT ≥ 80 × 10⁹/L;
• Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
• ALT and AST ≤ 2.5 × ULN; in cases of liver metastases, ALT and AST ≤ 5 × ULN;
• Endogenous creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula);
• Urinary protein \< (++), or 24-hour urinary protein \< 1.0 g.
• Normal coagulation function with no active bleeding

You may not qualify if:

• Previous receipt of any antitumor therapy for head and neck squamous cell carcinoma;
• Administration of a live vaccine within 4 weeks prior to enrollment or likely to occur during the study period;
• Active autoimmune disease or a history of autoimmune disease within 4 weeks prior to enrollment;
• Previous allogeneic bone marrow or organ transplantation;
• Uncontrolled hypertension prior to enrollment, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥90 mmHg;
• Any disease or condition prior to enrollment that affects drug absorption;
• Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Class \>2 congestive heart failure; ventricular arrhythmias requiring medication; LVEF (left ventricular ejection fraction) \<50%;
• Active or uncontrolled severe infection (≥CTCAE v5.0 Grade 2 infection); 9. Known human immunodeficiency virus (HIV) infection. History of clinically significant liver disease, including viral hepatitis \[known hepatitis B virus (HBV) carriers must be free of active HBV infection, i.e., HBV DNA positive (\>1×10⁴ copies/mL or \>2,000 IU/mL); known hepatitis C virus (HCV) infection with HCV RNA positive (\>1×10³ copies/mL) ;
• Any other disease, clinically significant metabolic abnormalities, physical examination abnormalities, or laboratory test abnormalities that, in the investigator's judgment, give reason to suspect that the patient has a condition or state that makes them unsuitable for the study drug (e.g., a history of epileptic seizures requiring treatment), or that will affect the interpretation of study results, or that places the patient at high risk;
• Patients whom the investigator deems unsuitable for enrollment in this study.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Chunhua She Chunhua She

CONTACT

+86 18622963076; nansechunhua@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 21, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share