Can a Three-Drug combo wipe out head and neck tumors before surgery?

NCT ID NCT07778732

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This trial is testing whether giving a combination of two newer drugs—an immunotherapy called adebrelimab and a targeted therapy called dalpiciclib—along with standard chemotherapy (cisplatin) before surgery can improve outcomes for people with locally advanced head and neck cancer. The study will enroll 32 adults with resectable tumors who have not had prior treatment. Participants will receive two cycles of the combination, followed by surgery, and researchers will measure how many achieve a complete pathological response—meaning no cancer cells remain in the removed tissue. The trial also tracks side effects and long-term survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A combination of adebrelimab (an immunotherapy), dalpiciclib (a targeted cancer drug), and cisplatin (chemotherapy), given before surgery.
What this could lead to
If successful, this approach could shrink or eliminate tumors before surgery, potentially improving long-term outcomes for people with head and neck cancer.
What could go wrong
This is a small, early-phase trial, so results may not apply broadly. The combination may cause significant side effects, and the hoped-for benefit is not guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 1. HGB ≥ 90 g/L; 2. NEUT ≥ 1.5 × 10⁹/L; 3. PLT ≥ 80 × 10⁹/L; 4. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); 5. ALT and AST ≤ 2.5 × ULN; in cases of liver metastases, ALT and AST ≤ 5 × ULN; 6. Endogenous creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula); 7. Urinary protein \< (++), or 24-hour urinary protein \< 1.0 g. * Normal coagulation function with no active bleeding 1. International Normalized Ratio (INR) ≤ 1.5; 2. 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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