Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phase
Phase 2
Started
2024-12-15
Last updated
2025-12-05
Condition(s) studied
HNSCCPD-1
Investigational drug(s) / intervention(s)
Tirellizumab combined with carboplatin and albumin-paclitaxel neoadjuvant therapy+surgeryTraditional surgery
Tirellizumab combined with carboplatin and albumin-paclitaxel neoadjuvant therapy+surgery: Tirellizumab 200mg will be administered on day 1 of each 21-day cycle (once every 3 weeks). Tirelizumab will be administered by intravenous infusion using an intravenous catheter containing a sterile, pyrogen free, low protein-binding, 0.2 or 0.22 micron diameter embedded filter or auxiliary filter.
As a routine precaution, patients must be monitored for at least 60 minutes in an area equipped with resuscitation equipment and first aid medication after the infusion of tirellizumab during cycle 1 and day 1 of cycle 2. Starting with cycle 3, it is required to be monitored for more than 30 minutes (inclusive) in an area equipped with resuscitation equipment and first aid medication.
The first infusion (day 1 of Cycle 1) will be completed within 60 minutes; If it is well tolerated, subsequent infusions can be completed within 30 minutes, which is the minimum time allowed by the infusion. Tirellizumab should not be administered at the same time as any other drug.The surgical method was exte
Traditional surgery: The control group was treated according to NCCN guidelines, including radical resection of oral cancer combined with selective neck lymphatic dissection
Study summary
Efficacy of Tirellizumab combined with TP neoadjuvant in the treatment of early Oral squamous cell carcinoma (cT1-2N0M0) versus standard treatment: a randomized controlled, single-center exploratory clinical study. Surgery is usually the preferred treatment for early oral squamous cell carcinoma (OSCC). However, the five-year survival rate of early oral cancer is only 75.8%, which is still not satisfactory compared with breast cancer and lung cancer. It is an urgent problem to explore the treatment mode of early oral squamous cell carcinoma patients. This study intends to conduct neoadjuvant therapy of tirellizumab, carboplatin and albumin-bound paclitaxel (TP) in patients with cT1-2N0M0 oral squamous cell carcinoma after neoadjuvant immunotherapy and standard surgical treatment (radical resection of oral cancer + selective neck lymph dissection). A randomized controlled, single-center exploratory clinical study compared with traditional radical resection of oral cancer plus selective neck lymph dissection was conducted to investigate its effectiveness through the difference of 2-year event-free survival (EFS).
This study plans to include 60 patients with early oral squamous cell carcinoma. The subjects will press 1: The proportion of 1 was randomly divided into Tirellizumab combined with TP neoadjuvant therapy combined with surgery (experimental group) and traditional surgery (control group). Tumor tissues, adjacent tissues, whole blood samples, saliva samples and stool samples of patients were collected to observe the imaging and pathological changes before and after treatment. Meanwhile, clinical information of patients was collected. Such as postoperative function and other quality of life indicators, pathological grade, stage, treatment, prognosis, serology, imaging, etc., the main evaluation and comparison of the experimental group and the control group of 2-year event-free survival (EFS) and 5-year overall survival (OS).
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Patients with early oral squamous cell carcinoma diagnosed as T1-2N0M0 according to the eighth edition of AJCC TNM stage;
* 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. Hemoglobin \>9g/dL in the last 14 days without blood transfusion or use of erythropoietin;
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).
Exclusion Criteria:
* Other malignant tumors are diagnosed, or oral cancer is not the beginning of neoadjuvant therapy;
* An active autoimmune disease requiring systemic treatment (e.g. use of disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to treatment. 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 \<1000 copies /ml (200 IU/ml) before initial dosing, 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;
Primary outcome measure(s)
2 years Event-Free Survival,EFS — 2 years 2-Year EFS (Event-Free Survival) refers to a key clinical endpoint used in oncology and other medical studies to evaluate the efficacy of treatments. It measures the percentage of patients who remain free of specific negative events for two years after starting treatment. These "events" can include disease progression, recurrence, or treatment-related complications, depending on the study's context.
Trial sites (1)
Facility
City
Region
Status
Sun yat-sen memorial hospital
Guangzhou
Guangdong
More Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.