Trial Title:
Neoadjuvant Chemotherapytreatment of Locally Advanced Head and Neck Squamous Cell Carcinoma
NCT ID:
NCT05522985
Condition:
Head and Neck Squamous Cell Carcinoma
Neoadjuvant Chemotherapy
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Conditions: Keywords:
Head and neck squamous cell carcinoma
Neoadjuvant chemotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Triprilimab combined with TP
Description:
Both interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3
cycles.
Arm group label:
TP（paclitaxel +cisplatin）
Arm group label:
Treprizumab combined with TP
Summary:
The objective of research is to evaluate the efficacy and safety of treprizumab injection
combined with AP regimen in the treatment of resectable locally advanced head and neck
squamous cell carcinoma.122 patients were randomly divided into two groups: the test
group (treprizumab injection combined with AP protocol) and the control group (TP
protocol); The patients in both groups were treated with three cycles of induction
therapy. After the induction therapy, the patients were evaluated and followed up with
surgery.
Detailed description:
The case report form shall be filled by the investigator, and each selected case must
complete the case report form. The completed case report form is used for data entry and
management.
All original data were retained by the research department.Full analysis set: according
to the principle of intention to analyze (ITT), all cases who received drug treatment and
took drugs at least once were analyzed for efficacy. For the case data that cannot
observe the whole treatment process, the last observation data shall be carried forward
to the final results of the study (LOCF).
Per-protocol set: all cases that comply with the study protocol, have good compliance,
have not taken prohibited drugs during the study period, and have completed the contents
specified in the case report form. No imputation was performed for missing data. Fas and
PPS were analyzed statistically for the efficacy of the drug.
Safety analysis set: all enrolled patients who have used the study drug at least once and
have safety records after drug use belong to the safety analysis set. This data set was
used for safety analysis.
All statistical analysis will be calculated by SPSS statistical analysis software. All
statistical tests are conducted by two-sided test. If the p value is less than or equal
to 0.05, the difference tested will be considered statistically significant. The
confidence interval is 95%.
Baseline data were analyzed according to the full analysis set, and all efficacy
indicators were analyzed according to the full analysis set and the compliance scheme
set; The safety analysis set is adopted for the safety analysis.
The sample size calculated by pass 11.0 software: according to the existing literature,
the PCR rate of neoadjuvant treatment for advanced head and neck squamous cell carcinoma
in our bureau is about 16%, and it is expected that the combined treatment with
treprizumab will be increased to 40%, so P1 is set to 40%. α= 0.05， β= 0.2, the sample
size was calculated using Simon optimal two stage designs for phase II clinical trial
model, and the planned number of enrolled cases was 122.
Criteria for eligibility:
Criteria:
Inclusion Criteria：
- The subject has head and neck squamous cell carcinoma confirmed by histopathology or
cytology.
- Resectable, clinical stage III or IV and no distant metastasis (AJCC 8th)
- Initial treatment patients who have not received chemotherapy, radiotherapy,
immunotherapy or biological therapy.
- There is at least one measurable lesion (RECIST 1.1 standard, see Annex 1).
- ECoG score: 0-1.
- Expected survival time ≥ 3 months.
- The functions of important organs meet the following requirements (no blood
component, cell growth factor, white blood medicine, platelet medicine and anemia
correction medicine are allowed to be used within 14 days before the first use of
the study drug);WBC≥3.0x109 /L，ANC≥2.0x109/L,HB≥90g/L, Platelets ≥ 100x109 / L,Serum
albumin ≥ 2.8g/dl,Total bilirubin ≤ 1.5xuln, ALT and AST ≤ 3.0xuln,Serum creatinine
≤ 1.5xuln or creatinine clearance rate > 60ml / min (Cockcroft Gault, see Appendix
4),Activated partial thromboplastin time (APTT) and international normalized ratio
(INR) ≤ 1.5xuln (for anticoagulant therapy using stable doses such as low molecular
weight heparin or warfarin and INR can be screened within the expected therapeutic
range of anticoagulants)
- No contraindications of chemotherapy and immunotherapy.
- No history of immune related diseases.
- No uncontrollable pneumonia and pulmonary infection.
- Subjects of childbearing age must agree to take effective contraceptive measures
during the trial; The serum or urine pregnancy test of women of childbearing age 72
hours before the start of chemotherapy must be negative.
- The subject has good compliance, can carry out treatment and follow-up, and
voluntarily complies with the provisions of this study.
- The subjects voluntarily signed informed consent. Exclusion Criteria
- Patients with distant metastasis.
- There are uncontrolled serious medical diseases, such as complicated serious medical
diseases, including serious heart disease, cerebrovascular disease, uncontrolled
diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer,
etc.
- Patients with a history of allergy or allergic constitution to any component of
monoclonal antibody drugs in the past.
- Uncontrollable cardiac clinical symptoms or diseases, such as heart failure above
NYHA grade II or left ventricular ejection fraction (LVEF) < 50% indicated by color
Doppler echocardiography; Unstable angina pectoris; Myocardial infarction occurred
within 1 year; Patients with clinically significant supraventricular or ventricular
arrhythmias requiring clinical intervention (including QTc interval ≥ 470 MS);
- Serious infection (CTC AE > grade 2) occurred within 4 weeks before the first use of
the study drug, such as severe pneumonia, bacteremia and infection complications
requiring hospitalization; Baseline chest imaging revealed active pulmonary
inflammation, symptoms and signs of infection within 2 weeks before the first use of
study drug, or the need for oral or intravenous antibiotic treatment (excluding
prophylactic use of antibiotics).
- Unexplained fever > 38.5 ° C occurred during the screening period and before the
first administration (tumor fever can be included in the group according to the
judgment of the investigator);
- Active autoimmune diseases and history of autoimmune diseases (such as interstitial
pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism
and hypothyroidism, including but not limited to these diseases or syndromes); But
does not include autoimmune mediated hypothyroidism treated with stable doses of
thyroid replacement hormone; Type I diabetes using a stable dose of insulin;
Patients with vitiligo or childhood asthma / allergy who have been cured and do not
need any intervention after adulthood;
- Have a history of immune deficiency, including HIV test positive, or have other
acquired and congenital immune deficiency diseases, or have a history of organ
transplantation and allogeneic bone marrow transplantation.
- Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA
exceeding 500 IU / ml, or patients with active hepatitis C virus (HCV) should be
excluded; Inactive hepatitis B surface antigen carriers, treated and stable
hepatitis B patients (HBV DNA < 500iu / ml), and cured hepatitis C patients can be
included in the group.
- Have a history of interstitial lung disease (excluding radiation pneumonia without
hormone treatment) and non-infectious pneumonia.
- Patients with active pulmonary tuberculosis infection found through medical history
or CT examination, or patients with a history of active pulmonary tuberculosis
infection within 1 year before enrollment, or patients with a history of active
pulmonary tuberculosis infection more than 1 year before but without formal
treatment.
- Patients who have received any of the following treatments;1)Received any
investigational drug within 4 weeks before the first use of investigational drug; 2)
Receive the last dose of anticancer treatment (including chemotherapy, radiotherapy,
targeted therapy, etc.) within 4 weeks before the first use of the study
drug;3)Subjects who need to be given corticosteroids (> 10 mg prednisone equivalent
dose per day) or other immunosuppressants for systemic treatment within 2 weeks
before the first use of the study drug, except for the use of corticosteroids for
local inflammation and prevention of allergy, nausea and vomiting. In the absence of
active autoimmune disease, inhaled or topical corticosteroids and adrenocortical
hormone replacement at doses > 10 mg / day prednisone efficacy dose were allowed ;4)
Those who have been vaccinated with anti-tumor vaccine or have been vaccinated with
live vaccine within 4 weeks before the first administration of the study drug; 5)
Major surgery or severe trauma within 4 weeks before the first use of study drug; 6)
Another clinical study was also included.
- There is dementia, mental state change or any mental illness that will hinder
understanding or making informed consent or filling out questionnaires.
- subjects with ≥ grade 2 peripheral neuropathy according to CTCAE V5.0;
- History of allergy or hypersensitivity to any therapeutic ingredient.
- Primary malignant tumors other than head and neck squamous cell carcinoma in the
past 5 years, except for fully treated basal cell or squamous epithelial cell skin
cancer, local prostate cancer after radical operation, and ductal carcinoma in situ
after radical operation.
- Those who need to be treated with other anti-tumor drugs.
- The investigator thinks that it is not suitable for enrollment.
- Pregnant or lactating women.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300000
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongling wang, MD
Phone:
+86 022 23340123
Phone ext:
3130
Email:
wanghongling86@163.com
Contact backup:
Last name:
Ze Zhang, MD
Phone:
+86 022 23340123
Phone ext:
3130
Email:
zhangze_smu@163.com
Investigator:
Last name:
Xudong Wang, Ph.D
Email:
Principal Investigator
Start date:
November 7, 2021
Completion date:
November 7, 2024
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05522985
