Phase 2 Thyroid Cancer Trial, Recruiting

Written by an AI model from the 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 are willing to take part and have signed a written consent form
• People aged 18 to 80 years old, of any gender
• People who have been diagnosed with locally advanced differentiated thyroid cancer (a specific type of thyroid cancer confirmed by a tissue sample)
• People whose cancer meets at least one of these conditions: surgery is not expected to be able to remove all or most of the cancer; or the cancer has grown beyond the thyroid gland into surrounding areas such as the skin, throat, windpipe, food pipe, nearby nerves, or major blood vessels
• People who are willing to have a tissue sample (biopsy) or surgery at the start and end of the trial
• People who have not had any cancer treatment before
• People who have at least one area of cancer that can be measured on a scan, following standard medical guidelines (RECIST v1.1)
• People with a general health score of 0–2 on the ECOG scale, meaning they are able to carry out at least some daily activities (confirm with trial site)
• People with an expected survival of more than 3 months
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before starting the study drug
• Men and women who could have children must use reliable contraception throughout the trial and for 60 days after the last dose
• People whose major organs are working well enough to meet specific blood and urine test results, including acceptable levels of blood cell counts, liver function, kidney function, blood clotting, and urine protein (confirm with trial site for exact values)

Who may not be able to join:

• People with a type of thyroid cancer that is not differentiated thyroid cancer, such as undifferentiated (anaplastic) thyroid cancer, medullary thyroid cancer, lymphoma, or sarcoma of the thyroid
• People who have already had thyroid cancer surgery aimed at removing all of the cancer
• People with cancer that has spread to the brain or the lining around the brain, and who have symptoms from this
• People who have had a different type of cancer within the past 5 years, except for certain early-stage or treated cancers such as cervical carcinoma in situ, treated basal cell skin cancer, or certain non-invasive bladder tumours
• People with a known immune system disorder, whether present from birth or developed later in life
• People with an active or previously diagnosed autoimmune or inflammatory condition (such as autoimmune hepatitis, lupus, inflammatory bowel disease, certain thyroid conditions, or asthma requiring ongoing treatment) — though some exceptions apply (confirm with trial site)
• People with a history of severe mental illness
• People with conditions that would affect how the body absorbs or processes the study drug, such as severe vomiting, chronic diarrhoea, bowel obstruction, or absorption problems
• People who have had major surgery within 4 weeks before joining, or who are expected to need major surgery during the trial
• People who have received iodine-131 treatment or other local cancer treatments within the past 3 months, or who plan to receive other cancer treatments during the trial (note: thyroid hormone replacement therapy is not prohibited)
• People who have previously had an organ transplant or bone marrow transplant
• People who have previously received targeted treatments that work against a protein called VEGF, such as anlotinib, apatinib, or bevacizumab
• People who have previously received immunotherapy drugs targeting certain immune system proteins (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 treatments)
• People who have used systemic immune-suppressing medications within 2 weeks before joining, or who are expected to need them during the trial — some exceptions apply for low-dose or topical steroids (confirm with trial site)
• People taking certain medications that can affect heart rhythm in a specific way (QTc prolongation) or that may interfere with how the study drug is processed by the body
• People with a known or suspected allergy to the study drugs (donafinib or similar drugs), or to related antibody-based medicines or their ingredients
• People whose cancer, based on scans, appears to have grown into major blood vessels, or where the treating doctor believes there is a high risk of serious bleeding during treatment
• People with active bleeding, abnormal blood clotting, or who are currently on blood-thinning or clot-dissolving therapy
• People who have had gastrointestinal bleeding in the past 4 weeks, or who have signs of a significant risk of gastrointestinal bleeding (such as active ulcers or certain test results)
• People who have had a hole in the bowel (gastrointestinal perforation), an abdominal fistula, or an abdominal abscess in the past 6 months
• People who have had a blood clot event in the past 6 months, such as a stroke, mini-stroke (TIA), deep vein thrombosis, or pulmonary embolism
• People with serious heart conditions, including a recent heart attack, severe angina, heart bypass surgery in the past 6 months, significant heart failure, uncontrolled irregular heartbeat, or uncontrolled high blood pressure
• People with certain active infections, including HIV, active hepatitis B or C, active tuberculosis, or other uncontrolled active infections
• People with other serious medical conditions that the treating doctor believes could affect safety, such as uncontrolled diabetes, chronic kidney disease, significant nerve damage, or uncontrolled thyroid problems
• People who have not fully recovered from a previous surgery, including those with unhealed wounds or serious post-surgical complications
• People who have received a live vaccine within 4 weeks before joining, or who may need one during the trial
• Pregnant or breastfeeding women, or men and women who could have children but are unwilling or unable to use effective contraception
• People with a history of alcohol, drug, or substance misuse in the past 6 months
• People who have taken part in another clinical drug or medical device trial within the past 4 weeks
• People who are unable to follow the trial schedule or attend required follow-up appointments
• People the treating doctor considers unsuitable for any other reason

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