Could a drug cocktail boost survival in early oral cancer?
NCT ID NCT07267286
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether adding the immunotherapy drug tirellizumab plus chemotherapy before standard surgery can improve outcomes for people with early oral squamous cell carcinoma. Sixty participants will be randomly assigned to either the drug combo plus surgery or surgery alone. The main goal is to see if the combo increases the number of patients who remain free of cancer-related events for two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tirellizumab (a PD-1 inhibitor) combined with carboplatin and albumin-bound paclitaxel
- What this could lead to
- If it works, this could improve survival and reduce recurrence for people with early oral cancer, offering a more effective treatment option.
- What could go wrong
- This is a small, early-phase exploratory study with only 60 participants. The combination therapy may cause side effects like immune reactions or infections, and it may not prove better than standard surgery alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2024
- Expected to finish
-
Aug 2032
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Sun yat-sen memorial hospital
Guangzhou, Guangdong, 510000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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