Trial Title:
Neoadjuvant Adebrelimab Plus Dalpiciclib in Head and Neck Squamous Cell Carcinoma
NCT ID:
NCT06199271
Condition:
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Conditions: Keywords:
Neoadjuvant therapy
Immunotherapy
CDK4/6 inhibitor
Locally advanced head and neck squamous cell carcinoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adebrelimab and dalpiciclib
Description:
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.
Arm group label:
Treatment group
Other name:
Dalpiclib hydroxyethanesulfonate tablets
Other name:
Adebrelimab iniection
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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).
2. 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.
3. Age greater than or equal to 18 and less than 75 at the time of study entry.
4. Karnofsky Performance Status (KPS) score ≥ 70 points.
5. No prior exposure to other relevant anti-tumor treatments.
6. No distant metastasis (DM).
7. Intention to undergo curative treatment.
8. 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.
9. Adequate hepatic function: bilirubin ≤ 1.5 x ULN; aspartate aminotransferase (AST)
and alanine aminotransferase (ALT) ≤ 2.5 x ULN.
10. 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.
11. 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.
12. No severe organic heart disease and arrhythmia.
13. 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.
14. Willingness and ability to sign an approved Informed Consent Form.
Exclusion Criteria:
1. Previous treatment of any other form of anti-tumor therapy;
2. Patients with allergies and congenital immunodeficiency;
3. active infection;
4. Previous organ transplantation;
5. History of autoimmune diseases or other conditions requiring prolonged systemic use
of corticosteroids or immunosuppressive therapy;
6. 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.);
7. Human Immunodeficiency Virus (HIV) positive;
8. Active hepatitis B or C infection (HBV DNA, HCV RNA exceeding normal upper limits);
9. 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.
10. 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.
11. Pregnant or lactating females;
12. Patients unwilling to use effective contraception during the treatment period and
the following 3 months.
13. Simultaneous participation in other clinical studies.
14. Patients in critical condition unable to complete the investigation.
15. 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.
16. Patients or spouses experiencing communication barriers or inability to respond
normally due to reasons such as confusion, aphasia, intellectual disability, etc.
17. Presence of other malignant tumor diseases.
18. Other factors deemed unsuitable or likely to affect the subject's participation or
completion of the study by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
January 31, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Zhongzheng Xiang
Agency class:
Other
Source:
Sichuan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06199271
