HNSCCPhase 2NCT07778732
Adebrelimab Combined With Dalpiciclib Isethionate Plus Chemotherapy for Neoadjuvant Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Adebrelimab Injection, Dalpiciclib Isethionate and Cisplatin in people with HNSCC, run by Tianjin Medical University Cancer Institute and Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HNSCC
- What is being tested?
- Adebrelimab Injection, Dalpiciclib Isethionate and Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
- International Normalized Ratio (INR) ≤ 1.5;
- Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times the upper limit of normal (ULN).
- Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and must voluntarily use appropriate contraception during the observation period and for 8 weeks after the last administration of the study drug; for men, they must be surgically sterilized or agree to use appropriate contraception during the observation period and for 8 weeks after the last administration of the study drug.
- Expected survival ≥ 12 months.
- Patients must voluntarily enroll in this study and sign an Informed Consent Form (ICF).
- Patients are expected to demonstrate good compliance and be able to follow up on efficacy and adverse reactions as required by the protocol.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this 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
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab InjectionDrug
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 IsethionateDrug
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.
CisplatinDrug
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 ResectionProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Neoadjuvant Triplet Combination Therapy Arm | Experimental | Not described Receives: Drug: Adebrelimab Injection; Drug: Dalpiciclib Isethionate; Drug: Cisplatin; Procedure: Radical Surgical Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At time of surgical resection (approximately 6 weeks after 2 cycles neoadjuvant treatment)
Secondary outcomes (6)
Major Pathological Response (MPR) Rate
Proportion of patients with ≤10% residual viable tumor cells in surgical specimen
Measured: At surgical resection
Objective Response Rate (ORR)
Percentage of participants with confirmed Complete Response (CR) or Partial Response (PR) per RECIST 1.1 on post-neoadjuvant contrast-enhanced CT
Measured: At the end of Cycle 2 (each neoadjuvant cycle is 28 days)
Disease Control Rate (DCR)
Proportion of patients with CR, PR or Stable Disease (SD) per RECIST 1.1
Measured: At the end of Cycle 2 (each neoadjuvant cycle is 28 days)
Progression-Free Survival (PFS)
Time from first study drug administration to first documentation of disease progression (local/regional/distant) or death from any cause
Measured: Up to 36 months from enrollment
1-Year Overall Survival (1y-OS) Rate
Percentage of subjects alive 12 months after first dose of neoadjuvant therapy
Measured: 12 months post first treatment
Incidence and Severity of Treatment-Related Adverse Events (TRAEs)
All adverse events graded per NCI CTCAE v5.0 from informed consent signing to 1 month after last study drug administration; summarize frequency, grade, causality and resolution
Measured: From screening through 30 days after final study drug dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HNSCCStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778732
- Sponsor's protocol ID
- HN-Neo-2026
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07778732
- Acronym / sponsor ID
- HN-Neo-2026
- Conditions
- HNSCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Triplet Combination Therapy Arm | Experimental | Drug: Adebrelimab Injection, Drug: Dalpiciclib Isethionate, Drug: Cisplatin, Procedure: Radical Surgical Resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adebrelimab InjectionDose: 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 | Neoadjuvant Triplet Combination Therapy Arm |
| Dalpiciclib Isethionate100mg/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 | Neoadjuvant Triplet Combination Therapy Arm |
| CisplatinDose: 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. | Drug | Neoadjuvant Triplet Combination Therapy Arm |
| Radical Surgical ResectionTiming: 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. | Procedure or surgery | Neoadjuvant Triplet Combination Therapy Arm |
Primary outcome
Pathological Complete Response (pCR) Rate
Time frame: At time of surgical resection (approximately 6 weeks after 2 cycles neoadjuvant treatment)
Percentage of subjects achieving pathological complete response in primary tumor and regional lymph nodes after neoadjuvant therapy (no viable tumor cells in surgical specimen)
6 secondary outcomes
Major Pathological Response (MPR) Rate
Time frame: At surgical resection
Objective Response Rate (ORR)
Time frame: At the end of Cycle 2 (each neoadjuvant cycle is 28 days)
Disease Control Rate (DCR)
Time frame: At the end of Cycle 2 (each neoadjuvant cycle is 28 days)
Progression-Free Survival (PFS)
Time frame: Up to 36 months from enrollment
1-Year Overall Survival (1y-OS) Rate
Time frame: 12 months post first treatment
Incidence and Severity of Treatment-Related Adverse Events (TRAEs)
Time frame: From screening through 30 days after final study drug dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebrelimab Injection, Dalpiciclib Isethionate and Cisplatin in people with HNSCC, run by Tianjin Medical University Cancer Institute and Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunhua She Chunhua She (+86 18622963076, nansechunhua@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) Rate (time frame: At time of surgical resection (approximately 6 weeks after 2 cycles neoadjuvant treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.