Head and Neck Squamous Cell CarcinomaPhase 2NCT06199271
Neoadjuvant Adebrelimab Plus Dalpiciclib in Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Adebrelimab and dalpiciclib in people with Head and Neck Squamous Cell Carcinoma, run by Zhongzheng Xiang.
Trial summary
This study is a single arm phase II trial including 30 patients with III-IVB (according to the 8th edition of UICC/AJCC staging) locally advanced head and neck squamous cell carcinoma (HNSCC) eligible for resection, who receive Adebrelimab plus Dalpiciclib as neoadjuvant regimen before surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Adebrelimab and dalpiciclib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2024to 31 Dec 2026
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pathologically diagnosed with HPV-negative head and neck squamous cell carcinoma (HNSCC), including oral, laryngeal, hypopharyngeal, and HPV-negative oropharyngeal carcinoma (with HPV testing methods for oropharyngeal carcinoma, including p16 immunohistochemistry or HPV DNA tests).
- Patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC), classified as stage III-IVB according to the 8th edition of UICC/AJCC staging.
- Age greater than or equal to 18 and less than 75 at the time of study entry.
- Karnofsky Performance Status (KPS) score ≥ 70 points.
- No prior exposure to other relevant anti-tumor treatments.
- No distant metastasis (DM).
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- Intention to undergo curative treatment.
- Adequate bone marrow function: total white blood cell count ≥ 3.5 × 10^9 /L, absolute lymphocyte count ≥ 0.8 × 10^9/L, absolute neutrophil count ≥ 1.5 × 10^9/L, platelets ≥ 100 × 10^9 /L, hemoglobin ≥ 90g/L.
- Adequate hepatic function: bilirubin ≤ 1.5 x ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN.
- Adequate renal function: serum creatinine ≤ 1.5 x ULN, creatinine clearance (Ccr) ≥ 60 ml/min (if using the Cockcroft-Gault formula), urinalysis indicating urinary protein less than 2+, or 24-hour urinary protein quantification < 1g.
- Adequate coagulation function: international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN. If the subject is currently receiving anticoagulant therapy, PT within the therapeutic range of the anticoagulant can be accepted.
- No severe organic heart disease and arrhythmia.
- Women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days before treatment. Both men and women of reproductive age must use highly effective contraception during the study and for 3 months after treatment.
- Willingness and ability to sign an approved Informed Consent Form.
Who cannot join
- Previous treatment of any other form of anti-tumor therapy;
- Patients with allergies and congenital immunodeficiency;
- active infection;
- Previous organ transplantation;
- History of autoimmune diseases or other conditions requiring prolonged systemic use of corticosteroids or immunosuppressive therapy;
- Patients with a history of use of the following drugs (CYP3A4 inhibitors: clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir, ritonavir, nefazodone, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, voriconazole and grape sleeve or grape sleeve juice, ziprasidone, lorlostazol, ticagrelor, aprepitant, netupitant, ondansetron, domperidone, etc.; CYP3A4 inducers: rifampicin, carbamazepine, enzalutamide, phenytoin, rifampicin and St. John's wort, efaviren, bosentan, modafinil, etc.);
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- Human Immunodeficiency Virus (HIV) positive;
- Active hepatitis B or C infection (HBV DNA, HCV RNA exceeding normal upper limits);
- Abnormal blood counts: White blood cells <3.5×10^9/L, absolute lymphocyte count <0.8×10^9/L, neutrophils <1.5×10^9/L, platelets <100×10^9/L, hemoglobin <90g/L; elevated bilirubin >1.5 times the upper limit of normal, transaminases (AST, ALT) >3 times the upper limit of normal (5 times if liver metastasis), serum creatinine >1.5 times the upper limit of normal; abnormal coagulation function, international normalized ratio (INR) or prothrombin time (PT) >1.5 times the upper limit of normal.
- Severe cardiovascular, respiratory, or immune system diseases, including urinary obstruction, positive cardiac stress test, myocardial infarction, arrhythmias, obstructive or restrictive lung disease, or other diseases that investigators believe may increase the risk of subjects.
- Pregnant or lactating females;
- Patients unwilling to use effective contraception during the treatment period and the following 3 months.
- Simultaneous participation in other clinical studies.
- Patients in critical condition unable to complete the investigation.
- Patients with a history of mental illness (e.g., schizophrenia, bipolar disorder, anxiety disorders, depression, phobias, etc.) or those diagnosed with a mental disorder at the time of clinical trial enrollment or their spouses.
- Patients or spouses experiencing communication barriers or inability to respond normally due to reasons such as confusion, aphasia, intellectual disability, etc.
- Presence of other malignant tumor diseases.
- Other factors deemed unsuitable or likely to affect the subject's participation or completion of the study by the investigator.
About this study
Official title: Neoadjuvant Adebrelimab Plus Dalpiciclib in HPV-negative Locally Advanced Head and Neck Squamous Cell Carcinoma: A Phase II Clinical Trial
This study is a single arm phase II trial including 30 patients with III-IVB (according to the 8th edition of UICC/AJCC staging) locally advanced head and neck squamous cell carcinoma (HNSCC) eligible for resection, who receive Adebrelimab plus Dalpiciclib as neoadjuvant regimen before surgery.
This proposed study will evaluate the efficacy and safety of preoperative administration of Adebrelimab plus Dalpiciclib in HNSCC who are eligible for resection.
Read the detailed description
In this study, eligible patients will be enrolled into study arm to accept study treatment. Pathological response rate and objective response rate will be the primary outcome measures. Adverse events will also be recorded.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Adebrelimab and dalpiciclib
- Keywords
- Neoadjuvant therapy, Immunotherapy, CDK4/6 inhibitor, Locally advanced head and neck squamous cell carcinoma
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab and dalpiciclibDrug
Also called Dalpiclib hydroxyethanesulfonate tablets, Adebrelimab iniection
Before surgery, the eligible patients received 3 cycles of adebrelimab (1200 mg intravenously every 3 weeks, Day 1, 22 and 43) and 2 cycles of dalpiciclib (150 mg, po, every 4 weeks, day 1-21 and 29-49). Administration dose adjustments were permitted according to the haematological or non-haematological toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients with resectable locally advanced head and neck squamous carcinoma cell carcinoma receive adebrelimab plus dalpiciclib before surgery. Receives: Drug: Adebrelimab and dalpiciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological response rate
The pathological response was evaluated by pTR (the appearance of tumor necrotic cells and keratin fragments with giant cell/tissue cell responses), including significant pathological response (Major pathological response, MPR, pTR-2 ≥ 50%), partial pathological response (Partial pathological response, PPR, pTR-1 10% -49%), and no pathological response (Non pathological response, NPR, pTR-0<10%).
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start31 Jan 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongzheng Xiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhongzheng Xiang, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199271
- Sponsor's protocol ID
- Neo-AdDa
- Status last verified
- Jan 2024
- First submitted
- 1 Dec 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Adebrelimab Plus Dalpiciclib in HPV-negative Locally Advanced Head and Neck Squamous Cell Carcinoma: A Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT06199271
- Acronym / sponsor ID
- Neo-AdDa
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Neoadjuvant therapy, Immunotherapy, CDK4/6 inhibitor, Locally advanced head and neck squamous cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhongzheng XiangUniversity, hospital or other
- Study start
- 31 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jan 2024 (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 study is a single arm phase II trial including 30 patients with III-IVB (according to the 8th edition of UICC/AJCC staging) locally advanced head and neck squamous cell carcinoma (HNSCC) eligible for resection, who receive Adebrelimab plus Dalpiciclib as neoadjuvant regimen before surgery.
This proposed study will evaluate the efficacy and safety of preoperative administration of Adebrelimab plus Dalpiciclib in HNSCC who are eligible for resection.
Detailed description
In this study, eligible patients will be enrolled into study arm to accept study treatment. Pathological response rate and objective response rate will be the primary outcome measures. Adverse events will also be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Adebrelimab and dalpiciclibPatients with resectable locally advanced head and neck squamous carcinoma cell carcinoma receive adebrelimab plus dalpiciclib before surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Pathologically diagnosed with HPV-negative head and neck squamous cell carcinoma (HNSCC), including oral, laryngeal, hypopharyngeal, and HPV-negative oropharyngeal carcinoma (with HPV testing methods for oropharyngeal carcinoma, including p16 immunohistochemistry or HPV DNA tests).
- Patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC), classified as stage III-IVB according to the 8th edition of UICC/AJCC staging.
- Age greater than or equal to 18 and less than 75 at the time of study entry.
- Karnofsky Performance Status (KPS) score ≥ 70 points.
- No prior exposure to other relevant anti-tumor treatments.
Key exclusion criteria (18 listed)
- Previous treatment of any other form of anti-tumor therapy;
- Patients with allergies and congenital immunodeficiency;
- active infection;
- Previous organ transplantation;
- History of autoimmune diseases or other conditions requiring prolonged systemic use of corticosteroids or immunosuppressive therapy;
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 and dalpiciclibAlso: Dalpiclib hydroxyethanesulfonate tablets, Adebrelimab iniectionBefore surgery, the eligible patients received 3 cycles of adebrelimab (1200 mg intravenously every 3 weeks, Day 1, 22 and 43) and 2 cycles of dalpiciclib (150 mg, po, every 4 weeks, day 1-21 and 29-49). Administration dose adjustments were permitted according to the haematological or non-haematological toxicity. | Drug | Treatment group |
Primary outcome
Pathological response rate
Time frame: 1-year
The pathological response was evaluated by pTR (the appearance of tumor necrotic cells and keratin fragments with giant cell/tissue cell responses), including significant pathological response (Major pathological response, MPR, pTR-2 ≥ 50%), partial pathological response (Partial pathological response, PPR, pTR-1 10% -49%), and no pathological response (Non pathological response, NPR, pTR-0<10%).
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 22 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebrelimab and dalpiciclib in people with Head and Neck Squamous Cell Carcinoma, run by Zhongzheng Xiang.
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 14 inclusion and 18 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 22 Jan 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological response rate (time frame: 1-year). 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 22 Jan 2024.