Trial Title:
Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Clinically Node-negative Head and Neck Squamous Cell Carcinoma
NCT ID:
NCT06323369
Condition:
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Paclitaxel
Cisplatin
Carboplatin
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab(neoadjuvant)
Description:
Tislelizumab 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day
cycle
Arm group label:
Neoadjuvant Tislelizumab + Chemotherapy (Arm A)
Intervention type:
Drug
Intervention name:
Cisplatin (neoadjuvant)
Description:
Cisplatin 75 mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day
cycle
Arm group label:
Neoadjuvant Tislelizumab + Chemotherapy (Arm A)
Intervention type:
Drug
Intervention name:
Nab-paclitaxel (neoadjuvant)
Description:
Nab-paclitaxel 260mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day
cycle
Arm group label:
Neoadjuvant Tislelizumab + Chemotherapy (Arm A)
Intervention type:
Procedure
Intervention name:
Surgical resection
Description:
Standard of care
Arm group label:
Neoadjuvant Tislelizumab + Chemotherapy (Arm A)
Arm group label:
Up-front Surgery (Arm B)
Intervention type:
Drug
Intervention name:
Cisplatin(adjuvant)
Description:
Cisplatin 100 mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day
cycle
Arm group label:
Neoadjuvant Tislelizumab + Chemotherapy (Arm A)
Arm group label:
Up-front Surgery (Arm B)
Intervention type:
Drug
Intervention name:
Tislelizumab(adjuvant)
Description:
Tislelizumab 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day
cycle
Arm group label:
Neoadjuvant Tislelizumab + Chemotherapy (Arm A)
Intervention type:
Radiation
Intervention name:
Radiation
Description:
Recommended, standard of care
Arm group label:
Neoadjuvant Tislelizumab + Chemotherapy (Arm A)
Arm group label:
Up-front Surgery (Arm B)
Intervention type:
Drug
Intervention name:
Carboplatin(neoadjuvant)
Description:
Cisplatin AUC=5 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Arm group label:
Neoadjuvant Tislelizumab + Chemotherapy (Arm A)
Intervention type:
Drug
Intervention name:
Carboplatin(adjuvant)
Description:
Cisplatin AUC=5 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Arm group label:
Neoadjuvant Tislelizumab + Chemotherapy (Arm A)
Arm group label:
Up-front Surgery (Arm B)
Summary:
A prospective, randomized, open-label, multicenter Phase 2 trial designed to compare the
efficacy and safety of Tislelizumab combined with chemotherapy followed by surgery versus
up-front surgery in resectable clinically node-negative head and neck squamous cell
carcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Have a histologically confirmed diagnosis of HNSCC which is planned for treatment with
curative intent including surgical resection: stage III/IVA.
Greater than or equal to 18 and less than 80 years of age at time of study entry.
ECOG performance status of 0 or 1. Measurable disease as per RECIST 1.1. Patients must
have no prior exposure to immune-mediated therapy, including anti- cytotoxic T-lymphocyte
protein 4 (CTLA-4), anti-programmed cell death 1, anti-programmed cell death 1 ligand 1
(PD-L1), or anti-programmed cell death ligand 2 antibodies, excluding therapeutic
anticancer vaccines.
Screening labs must meet the following criteria and must be obtained within 14 days prior
to registration:
Adequate hepatic and renal function as demonstrated by
Serum creatinine < 1.5 X ULN or CrCl > 40mL/min (if using the Cockcroft-Gault formula
below):
Males: Creatinine CL (mL/min) = (Weight (kg) x (140 - Age))/(72 x serum creatinine
(mg/dL)) Females: Creatinine CL (mL/min) = (Weight (kg) x (140 - Age))/(72 x serum
creatinine (mg/dL))x 0.85 AST/ALT ≤ 3 x ULN Total Bilirubin ≤ 1.5 x ULN (except subjects
with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
Adequate bone marrow function as demonstrated by:
Absolute Neutrophil Count >1,500/µL Platelets > 100 X 103/µL Hemoglobin > 9.0 g/dL Women
of reproductive potential should have a negative serum or urine pregnancy test (minimum
sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 21
days of study enrollment.
Women of reproductive potential must use highly effective contraception methods to avoid
pregnancy for 23 weeks after the last dose of study drugs; "women of reproductive
potential" is defined as any female who has experienced menarche and who has not
undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not
postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman
over 45 in the absence of other biological or physiological causes; in addition, women
under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level
less than 40 mIU/mL.
Men of reproductive potential who are sexually active with women of reproductive
potential must use any contraceptive method with a failure rate of less than 1% per year;
men who are receiving the study medications will be instructed to adhere to contraception
for 31 weeks after the last dose of study drugs; men who are azoospermic do not require
contraception.
Ability to understand and willingness to sign an IRB approved written informed consent
document (or that of legally authorized representative, if applicable).
Subject is willing and able to comply with the protocol for the duration of the study
including undergoing treatment and scheduled visits and examinations including follow up.
Subjects must agree to allow use of any pre-treatment tissue remaining after definitive
diagnosis is made (ie, archival and or fresh tissue) for research purposes. In addition,
subjects must consent to allow use of their residual post-operative tissue for research
purposes.
Exclusion Criteria:
Is currently participating in or has participated in a study of an investigational agent
within 4 weeks of the first dose of treatment or has not recovered (i.e., ≤ Grade 1 or at
baseline) from adverse events due to agents administered more than 4 weeks earlier.
Has had another known invasive malignancy within the previous 5 years and/or has had
surgery, chemotherapy, targeted small molecule therapy or radiation therapy within 5
years for a known malignancy prior to study day 0.
If subject received major surgery for any other reason, they must have recovered
adequately from the toxicity and/or complications from the intervention prior to starting
therapy.
Subjects with a condition requiring systemic treatment with either corticosteroids (> 10
mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of
day -5. Inhaled or topical steroids, and adrenal replacement steroid > 10 mg daily
prednisone equivalent, are permitted in the absence of active autoimmune disease.
Has an active autoimmune disease requiring systemic steroid treatment within the past 3
months or a documented history of clinically severe autoimmune disease, or a syndrome
that requires systemic steroids.
Active, known or suspected autoimmune disease. Note: Subjects are permitted to enroll if
they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune
condition only requiring hormone replacement, psoriasis not requiring systemic treatment,
or conditions not expected to recur in the absence of an external trigger .
Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
Has an active infection requiring systemic therapy. Has received prior therapy with an
anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug
specifically targeting T-cell costimulation or immune checkpoint pathways.
A history of allergic reaction attributed to compounds of similar chemical or biologic
composition to the treatment or other agents used in the study.
Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the trial, interfere with the subject's participation
for the full duration of the trial, or is not in the best interest of the subject to
participate, in the opinion of the treating investigator.
Has known psychiatric or substance abuse disorders that would interfere with cooperation
with the requirements of the trial.
Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the trial, starting with the pre-screening or screening visit
through 23 weeks after the last dose of trial treatment.
Has a known history of Human Immunodeficiency Virus (HIV) infection (HIV 1/2 antibodies).
Has known active Hepatitis B or C. Known history of active TB (bacillus tuberculosis ).
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Medical Ethics Committee of Sun Yat-sen Memorial Hospital
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Recruiting
Contact:
Last name:
Song Fan, Doctor
Phone:
13570536658
Phone ext:
+86
Email:
fansong2@mail.sysu.edu.cn
Investigator:
Last name:
Song Fan, Doctor
Email:
Principal Investigator
Start date:
March 25, 2024
Completion date:
September 25, 2029
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06323369