Phase 3 Head and Neck Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 75 years old at the time of joining the trial
• People who are generally able to carry out normal daily activities with little to no limitation (as assessed by a standard medical scale called ECOG, with a score of 0 or 1)
• People whose cancer has been confirmed by a tissue sample (biopsy) to be a type of mouth cancer called oral squamous cell carcinoma (OSCC), affecting areas such as the tongue (front two-thirds), gums, inner cheeks, floor of the mouth, hard palate, or the area behind the back teeth
• People whose cancer is at a stage classified as Stage III or IVA based on a standard cancer staging system (AJCC 8th edition), which broadly means the cancer may have spread to nearby lymph nodes or the tumour may be of a certain size (confirm with trial site for exact staging details)
• People who are willing to have surgery as part of their treatment
• People who have at least one tumour that can be measured using standard imaging guidelines (called RECIST v1.1)
• People who fully understand the trial, agree to take part voluntarily, and sign a consent form
• People whose blood test results show their major organs (such as bone marrow, liver, kidneys, and heart) are functioning adequately, including all of the following:
  • Enough white blood cells (neutrophils) without needing a growth-stimulating injection in the 14 days before the blood test
  • Enough platelets (cells that help blood clot), without having had a blood transfusion in the 14 days before the blood test
  • Haemoglobin (a measure of red blood cells) above a certain level, without a recent transfusion or medication to boost red blood cells in the past 14 days
  • Liver function markers (bilirubin, ALT, AST) within acceptable ranges
  • Kidney function within acceptable ranges, including a measure of how well the kidneys filter the blood
  • Normal blood clotting function
  • Normal thyroid hormone levels (or, if the main thyroid hormone test is slightly abnormal, other thyroid measures must still be within normal range)
  • Normal heart enzyme levels in the blood, with minor variations accepted if the doctor considers them clinically unimportant
• Women who could become pregnant must have a negative pregnancy test within 3 days before starting treatment
• All participants who could father or become pregnant must agree to use highly effective contraception throughout the treatment period and for at least 120 days after the last dose of the study drug, or 180 days after the last chemotherapy dose

Who may not be able to join:

• People who have previously received certain types of immunotherapy drugs that target specific immune pathways (such as PD-1, PD-L1, PD-L2, or CTLA-4 inhibitors)
• People who have taken part in another interventional clinical trial or used an experimental drug or device within the 4 weeks before joining this trial
• People who have previously had radiotherapy to the head, neck, or jaw/face area
• People who have used certain traditional Chinese medicines or immune-boosting treatments for mouth cancer (such as thymosin, interferon, or interleukin) within 2 weeks before starting the trial
• People who have had an active autoimmune disease (where the immune system attacks the body) in the past 2 years that required systemic treatment such as steroids or immune-suppressing medicines — though some exceptions may apply, such as:
  • Underactive thyroid controlled with standard hormone replacement
  • Diabetes controlled with insulin
  • Adrenal or pituitary gland conditions treated with low doses of corticosteroids
• People who have used immune-suppressing medicines, specifically:
  • Steroid tablets or injections throughout the body within 1 week before starting the trial
  • Other immune-suppressing drugs (note: nasal sprays, inhalers, skin creams containing steroids, and very low daily doses of steroids such as prednisone 10 mg or less are generally permitted)
• People who have previously received systemic cancer treatments, unless it has been at least 12 months since their last chemotherapy and before starting this trial's pre-surgery treatment
• People who have previously had an organ transplant or a bone marrow/stem cell transplant from another person (corneal transplants are an exception)
• People with a known allergy or sensitivity to any of the study drugs used in this trial (sintilimab, carboplatin, cisplatin, or nab-paclitaxel) or their ingredients
• People who have not yet recovered from side effects of previous treatments to an acceptable level before joining the trial (minor persistent fatigue or hair loss are exceptions)
• People known to have HIV infection
• People with untreated, active hepatitis B infection — though people with certain low-level or well-managed hepatitis B may be considered (confirm with trial site)
• People with active hepatitis C infection
• People who have received a live vaccine within 30 days before starting the trial (inactivated vaccines such as standard flu shots are generally permitted; live nasal spray vaccines are not)
• Women who are pregnant or breastfeeding
• People with serious or poorly controlled health conditions, including:
  • Significant heart rhythm problems, unstable chest pain, or heart failure
  • A heart attack, stroke, or related event within the past 6 months
  • Poorly controlled high blood pressure
  • Certain lung conditions, including lung inflammation requiring steroid treatment in the past year, or active scarring lung disease
  • Active infections requiring treatment, or serious uncontrolled infections
  • Active tuberculosis of the lungs
  • Certain serious bowel or digestive conditions such as active diverticulitis, abdominal abscess, or bowel blockage
  • Liver cirrhosis, serious liver disease, or active hepatitis
  • Poorly controlled diabetes (with fasting blood sugar above a certain level)
  • Significant kidney problems shown by protein in the urine
  • Severe mental health conditions that may affect the ability to follow the trial procedures
• People who have any other condition that the trial doctor considers makes participation unsuitable

Important: Always verify eligibility with the trial site directly before applying.