Phase 2 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 who have given written consent and are willing to follow the study plan.
• People aged 18 to 75 years old.
• People whose cancer has been confirmed by a tissue biopsy to be squamous cell carcinoma of the larynx (voice box) or hypopharynx (lower throat).
• People with locally advanced laryngeal or hypopharyngeal cancer that doctors have determined can be treated with surgery, at a specific stage of disease as classified by a standard cancer staging system (confirm with trial site).
• People who have at least one tumour that can be measured using standard imaging methods before treatment begins.
• People who have already received a combination of immunotherapy and chemotherapy before surgery (neoadjuvant treatment), and whose primary tumour has partially shrunk in response, making them suitable for surgery that aims to preserve the organ.
• People expected to live for more than 3 months.
• People who are generally able to carry out daily activities with no or minimal limitations, as rated by a standard medical scale (ECOG score of 0 or 1).
• People whose blood counts and organ function meet specific minimum requirements, including healthy enough levels of white blood cells, platelets, haemoglobin, liver enzymes, kidney function, and blood clotting markers (confirm specific values with trial site).
• People with hepatitis B who have a very low or undetectable level of the virus in their blood at the time of screening, or who are on stable antiviral treatment (confirm specific conditions with trial site).
• People who have had hepatitis C but test negative for active hepatitis C virus in their blood at screening.
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting treatment, and must use an accepted form of contraception during the study and for a set period after the last dose of each study drug.
• Men who have not had a sterilisation procedure must be willing to use an accepted form of contraception during the study and for a set period after the last dose of each study drug.

Who may not be able to join:

• People who have had an allergic reaction to toripalimab, paclitaxel, or cisplatin, or to any of their ingredients.
• People who already have a tracheostomy (a surgical opening in the throat for breathing) due to problems with their larynx before treatment began.
• People who have had another type of cancer, unless it was fully treated more than 5 years ago with no recurrence (some exceptions such as certain skin cancers may apply — confirm with trial site). People with both hypopharyngeal cancer and a separate, non-adjacent oesophageal cancer are also not eligible.
• People with significant uncontrolled heart problems, including moderate-to-severe heart failure, unstable chest pain (angina), a heart attack within the past year, or serious heart rhythm problems that have required treatment.
• People who have taken an experimental drug within the 4 weeks before starting the study.
• People currently taking part in another interventional clinical trial.
• People who need ongoing high-dose steroid tablets or other medicines that suppress the immune system within 2 weeks before starting the study (some exceptions apply — confirm with trial site).
• People who received an anti-cancer vaccine or a live vaccine within 4 weeks before starting the study (or within 2 weeks for a COVID-19 vaccine).
• People who have had major surgery or a serious injury within 4 weeks before starting the study.
• People who have not yet recovered from significant side effects of a previous cancer treatment (with some exceptions such as hair loss or mild nerve-related symptoms from prior platinum chemotherapy).
• People who have had a serious infection within 4 weeks before starting the study, such as severe pneumonia, blood poisoning (sepsis), or another complicated infection requiring hospital treatment or antibiotics.
• People with an active autoimmune disease (where the immune system attacks the body's own tissues), or a history of serious autoimmune conditions such as lung inflammation, bowel inflammation, or liver inflammation (some stable, well-managed conditions may be exceptions — confirm with trial site).
• People with a known immune deficiency condition, a positive HIV test, or a history of organ or bone marrow transplant.
• People with a history of lung inflammation not caused by infection (interstitial lung disease or non-infectious pneumonitis), except radiation-related lung inflammation not treated with steroids.
• People with an active tuberculosis (TB) infection, a TB infection diagnosed within the past year, or a past TB infection that was never properly treated.
• People with active hepatitis B (with virus levels above the specified threshold) or active hepatitis C (with detectable virus levels in the blood).
• People with a known history of substance abuse, alcohol abuse, or drug addiction.
• Women who are pregnant or breastfeeding.
• People who, in the opinion of the study doctor, have other serious medical, mental health, or social circumstances that could affect their safety or the reliability of the study data.

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