Combining Tirellizumab with chemotherapy for early oral cancer treatment

A Single-center Exploratory Clinical Study of Neoadjuvant Tirellizumab Combined With Chemotherapy for Early Oral Squamous Cell Carcinoma (cT1-2N0M0)

This study is testing if combining a new drug called Tirellizumab with chemotherapy can help people with early-stage oral cancer avoid surgery and improve their treatment outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Academic / other)
• Drugs / interventions: chemotherapy, tislelizumab, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06130332 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of Tirellizumab, a PD-1 inhibitor, in combination with chemotherapy for patients diagnosed with early-stage oral squamous cell carcinoma (OSCC). The study aims to determine the effectiveness of this neoadjuvant treatment approach in patients with clinically negative cervical lymph nodes, potentially reducing the need for elective neck dissection. By exploring this treatment model, the trial seeks to address the challenges associated with current surgical practices and improve patient outcomes. Participants will undergo baseline health assessments to ensure eligibility before receiving the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with early oral squamous cell carcinoma classified as T1-2N0M0.

Not a fit: Patients with a history of other malignant tumors or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more targeted treatment for early oral cancer patients, minimizing unnecessary surgeries and associated complications.

How similar studies have performed: Previous studies have explored similar neoadjuvant therapies, but this specific combination of Tirellizumab and chemotherapy in early OSCC is relatively novel.

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 \&lt 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;

Where this trial is running

Guangzhou, Guangdong

• Sun yat-sen memorial hospital — Guangzhou, Guangdong, China (Recruiting)

Conditions Oral Cancer; PD-1