Trial Title:
Neoadjuvant Tirellizumab Combined With Chemotherapy for Early Oral Squamous Cell Carcinoma(HNC-SYSU-004)
NCT ID:
NCT06130332
Condition:
Oral Cancer
PD-1
Conditions: Official terms:
Carcinoma, Squamous Cell
Mouth Neoplasms
Squamous Cell Carcinoma of Head and Neck
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PD-1 with chemotherapy
Description:
Tirellizumab+Carboplatin+albumin-bound paclitaxel:2 courses
Tirellizumab,+Carboplatin+albumin-bound paclitaxel Tirellizumab (IV), dose= 200mg , day=1
, cycle length: 21 days. Carboplatin (IV), dose=300mg/m2, day= 1, cycle length: 21 days.
albumin-bound paclitaxel (IV), dose=260mg/m2, day= 1, cycle length: 21 days.
Intervention: Drug: Tirellizumab, Carboplatin, albumin-bound paclitaxel:2 cycles
Surgery：Enlarged local excision，excision with the safe margin 1.0-1.5cm away from the
original tumor
Arm group label:
PD-1 with chemotherapy
Intervention type:
Procedure
Intervention name:
upright surgery
Description:
Surgery：Primary resection，excision with the safe margin 1.0-1.5cm away from the original
tumor
selective neck dissection:I II III region neck dissection
Arm group label:
upright surgery
Summary:
Surgery is usually the first choice for early-stage oral squamous cell carcinoma (OSCC).
However, there is currently a lack of consensus on whether patients with clinically
negative cervical lymph nodes (N0) should undergo elective neck dissection (END) at the
same time. About 20-30% of cT1-2N0M0 oral cancer patients have occult lymph node
metastasis, and existing examination methods cannot accurately predict occult cervical
lymph node metastasis. Therefore, most clinical retrospective and prospective studies
recommend END for cN0 patients. Previous studies have found that no cancer cells were
found in the cervical lymph nodes of 70% of patients after END. This unselective END can
cause patients with accessory nerve dysfunction, neck scars, etc., and prolong
hospitalization and surgery time. Exploring the treatment model for patients with
early-stage oral squamous cell carcinoma is an urgent problem that needs to be solved.
This study intends to conduct a study on the neoadjuvant treatment of tislelizumab,
carboplatin, and albumin-bound paclitaxel. After neoadjuvant immunotherapy in patients
with early-stage oral cancer (T1-2N0M0), the primary tumor is treated with standard
surgical treatment. Comparison with A single-center exploratory clinical study of
traditional oral cancer radical resection + selective neck lymphadenectomy was conducted
to explore its effectiveness through the difference in 2-year disease-free survival
(DFS).
This research plan covers 40 patients with early-stage oral squamous cell carcinoma. They
will be randomly divided into tislelizumab, chemotherapy combined with surgery
(experimental group) and traditional surgery (control group) in a 1:1 ratio. The
patients' tumors will be collected. Tissues, adjacent cancer tissues, whole blood
samples, saliva samples, and matrix samples were used to observe the changes in imaging
and pathology compared with treatment. At the same time, the clinical information of the
patients was collected, such as quality of life indicators such as judgment function,
pathological grading, staging, treatment, Spine, serology, imaging, etc., mainly to
evaluate the 2-year event-free survival (EFS) between the experimental group and Weather
Forecast, and the 3-year overall survival (OS) and patient quality of life between the
experimental group and Weather Forecast.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with early oral squamous cell carcinoma diagnosed as T1-2N0M0 according to
the eighth edition of AJCC classification;
- No history of other malignant tumors;
- 18-75 years old;
- Baseline inspection is normal:
1. The absolute value of neutrophil (ANC) ≥1.5x109/L in the past 14 days without
the use of granulocyte colony-stimulating factor;
2. Platelets ≥100×109/L without blood transfusion in the past 14 days;
3. In the case of no blood transfusion or use of erythropoietin in the last 14
days, hemoglobin > 9g/dL;
4. Total bilirubin ≤1.5× upper limit of normal (ULN);
5. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) in ≤2.5×ULN
(patients with liver metastases allowed ALT or AST ≤5×ULN);
6. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by
Cockcroft-Gault formula) ≥60 ml/min;
7. Good coagulation function, defined as International standardized ratio (INR) or
prothrombin time (PT) ≤1.5 times ULN;
8. Normal thyroid function, defined as thyroid stimulating hormone (TSH) within
the normal range. If baseline TSH is outside the normal range, subjects with
total T3 (or FT3) and FT4 within the normal range can also be enrolled;
9. The myocardial enzyme profile is within the normal range (if the researchers
comprehensively judge that the simple laboratory abnormality is not clinically
significant, it is also allowed to enter the group);
10. For female subjects of reproductive age, a urine or serum pregnancy test should
be performed within 3 days prior to receiving the first study drug
administration (day 1 of cycle 1) and the result is negative. If the urine
pregnancy test results cannot be confirmed as negative, a blood pregnancy test
is requested. Women of non-reproductive age were defined as at least one year
after menopause or having undergone surgical sterilization or hysterectomy;
11. If there is a risk of conception, all subjects (male or female) are required to
use contraception with an annual failure rate of less than 1% for the entire
duration of treatment up to 120 days after the last study drug administration
(or 180 days after the last chemotherapy drug administration).
- Sign informed consent.
Exclusion Criteria:
- Other malignant tumors are diagnosed, or oral cancer is not the beginning of
neoadjuvant therapy;
- Prior to treatment, an active autoimmune disease requiring systemic treatment (such
as the use of disease-modifying drugs, glucocorticoids, or immunosuppressants) has
occurred within the previous 2 years. Replacement therapies (such as thyroxine,
insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are
not considered systemic therapy;
- known allogeneic organ transplantation (other than corneal transplantation) or
allogeneic hematopoietic stem cell transplantation;
- Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody
positive);
- untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number
detected greater than the upper limit of normal value in the laboratory of the study
center);
Note: Hepatitis B subjects who meet the following criteria can also be enrolled:
1. HBV viral load < before first dosing; 1000 copies /ml (200 IU/ml), subjects should
receive anti-HBV therapy throughout study treatment to avoid viral reactivation;
2. For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-) and HBV viral load (-),
prophylactic anti-HBV therapy is not required, but close monitoring of viral
reactivation is required;
- active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above
the lower limit of detection);
- Pregnant or lactating women;
- The presence of any serious or uncontrolled systemic disease, such as:
1) The resting electrocardiogram has major abnormal rhythm, conduction or morphology,
such as complete left bundle branch block, heart block above Ⅱ degree, ventricular
arrhythmia or atrial fibrillation; 2) Unstable angina pectoris, congestive heart
failure, New York Heart Association (NYHA) grade ≥ 2 chronic heart failure;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun yat-sen memorial hospital
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Haotian Cao, MD
Phone:
008618583879908
Email:
caobleat@hotmail.com
Contact backup:
Last name:
Qunxing Li, MD
Phone:
008618320699771
Email:
liqx350@126.com
Investigator:
Last name:
Jinsong Li, MD
Email:
Principal Investigator
Start date:
September 1, 2023
Completion date:
August 31, 2030
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/NCT06130332
