Receive immune therapy and chemotherapy before surgery for early-stage mouth cancer

Recruiting

What is this trial?

This trial is testing whether a combination of Tirellizumab (an immune-boosting drug), chemotherapy, and surgery can better treat early-stage mouth cancer compared to surgery alone. The study will compare patients who receive the new medication and chemotherapy before surgery with patients who have traditional surgery, measuring how well each approach works over two years.

Many patients with early-stage mouth cancer currently have surgery to remove lymph nodes in the neck even though most don't actually have cancer in those nodes. This unnecessary surgery can cause lasting problems like nerve damage and scarring. Researchers hope this new treatment approach can help identify which patients truly need neck surgery and which ones don't, reducing unnecessary procedures and improving quality of life.

Do you qualify?

You likely qualify if…

you have been diagnosed with early-stage mouth cancer (specifically T1-2N0M0 stage)
you are between 18 and 75 years old
you have never had another type of cancer
your blood work shows healthy levels of blood cells, liver function, kidney function, and thyroid function
if you are a woman of childbearing age, you test negative for pregnancy and agree to use reliable birth control during and after treatment
you are willing to sign an informed consent form

You likely don't qualify if…

you have a history of other cancers
you have an active autoimmune disease requiring ongoing medication (with some exceptions for hormone replacement)
you have received an organ or stem cell transplant
you have HIV or untreated hepatitis B
you have already started any treatment for your oral cancer before enrolling

What participation looks like

If you are randomly assigned to the treatment group, you would receive two cycles of the new medication combined with chemotherapy intravenously (through your vein), with each cycle lasting 21 days. After completing these two cycles, you would have surgery to remove the primary tumor with a safe margin of tissue around it, and selective removal of lymph nodes in the neck if needed. Throughout the study, you would provide tissue samples, blood samples, and saliva samples so researchers can monitor how the cancer and your body respond to treatment.

New Immune Therapy Combined With Chemotherapy Before Surgery for Early Mouth Cancer

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)