Tirellizumab Combined With TP Neoadjuvant Therapy in the Treatment of Early Oral Squamous Cell Carcinoma （HNC-SYSU-005）

NCT07267286 | Active Not Recruiting Phase 2

• 1 other identifier: SYSKY-2024-1018-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

HNSCC; PD-1

Keywords

HNSCC; PD-1

Outcome Measures

Primary Outcomes (1)

• 2 years Event-Free Survival，EFS

  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.

  2 years

Secondary Outcomes (5)

• Overall survival

  5 years

• Major pathologic response

  6 weeks

• Quality of life assessed by Health-related Quality of Life,HRQoL.

  2 years

• Objective response rate, ORR

  6 weeks

• Adverse events rated by NCI-CTCAE v5.0

  2 years

Study Arms (2)

Tirellizumab combined with TP neoadjuvant therapy combined with surgery

EXPERIMENTAL

All subjects in the experimental group were given 200mg of tirellizumab before surgery, intravenous infusion on the first day of each cycle, 1 cycle every 3 weeks (Q3W), a total of 2 cycles, in which the operation was scheduled for 29-56 days after the first administration; At the same time, the administration cycle of carboplatin and albumin-bound paclitaxel was 1 cycle every 3 weeks (Q3W). Carboplatin was administered on the first day of each cycle, 300mg/m2, intravenous infusion, infusion time ≥1h; Albumin-bound paclitaxel 260mg/m2 was administered on the first day of each cycle for 30min intravenously.

Drug: Tirellizumab combined with carboplatin and albumin-paclitaxel neoadjuvant therapy+surgery

Traditional surgery

ACTIVE COMPARATOR

The control group was treated according to NCCN guidelines, including radical resection of oral cancer combined with selective neck lymphatic dissection.

Procedure: Traditional surgery

Interventions

Tirellizumab combined with carboplatin and albumin-paclitaxel neoadjuvant therapy+surgery DRUG

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

Tirellizumab combined with TP neoadjuvant therapy combined with surgery

Traditional surgery PROCEDURE

The control group was treated according to NCCN guidelines, including radical resection of oral cancer combined with selective neck lymphatic dissection

Traditional surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• years old;
• Baseline inspection is normal:
• The absolute value of neutrophil (ANC) ≥1.5x109/L in the past 14 days without the use of granulocyte colony-stimulating factor;
• Platelets ≥100×109/L without blood transfusion in the past 14 days;
• Hemoglobin \>9g/dL in the last 14 days without blood transfusion or use of erythropoietin;
• Total bilirubin ≤1.5× upper limit of normal (ULN);
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) in ≤2.5×ULN (patients with liver metastases allowed ALT or AST ≤5×ULN);
• Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml/min;
• Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;
• 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;
• 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);
• 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;
• 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).

You may not qualify if:

• 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:
• 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;
• 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:
• \) 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;

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun yat-sen memorial hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 5, 2025
• Study Start: December 15, 2024
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2032
• Last Updated: December 5, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)