Phase 2 Oesophageal 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 between 18 and 75 years.
• People who have been diagnosed with advanced, inoperable squamous cell cancer of the oesophagus (food pipe) that has either come back in nearby lymph nodes or spread to other parts of the body, confirmed by a tissue or cell sample.
• People whose cancer tests show a specific protein called EGFR is present at high levels or that the EGFR gene is amplified — tested through special laboratory methods (note: EGFR testing requirements differ between the two phases of the trial; confirm with the trial site which phase applies).
• People whose cancer has continued to grow or spread after at least one previous treatment.
• People who are able to carry out normal daily activities with little or no limitation, as measured by a standard scale called ECOG (scores 0 or 1).
• People whose blood test results within 7 days before starting treatment show that the blood, liver, kidney, heart, and clotting functions all meet the required levels (the trial site will check these results).
• Women who could become pregnant must agree to use appropriate contraception from the screening stage until 3 months after treatment ends, must not be breastfeeding, and must have a negative pregnancy test within 7 days before treatment starts.
• Men must agree to use appropriate contraception, or have had a surgical procedure for sterilisation, during the study and for 8 weeks after the last dose.
• People who are willing to take part voluntarily, sign a consent form, and agree to follow the study requirements and attend follow-up visits.

Who may not be able to join:

• People who have had another type of cancer in the past five years, except for certain fully treated skin cancers (basal cell carcinoma) or early-stage cervical cancer (carcinoma in situ).
• People who have an active autoimmune disease or a history of one.
• People who have had a severe allergic reaction — serious enough to require hospitalisation — to large-molecule protein medicines, or who have known allergies to either of the study drugs (Afatinib or Palbociclib) or their ingredients.
• People for whom either Palbociclib or Afatinib is otherwise medically unsuitable.
• People who have previously been treated with a type of drug called an EGFR inhibitor or a CDK4/6 inhibitor.
• People who have received a live vaccine (such as flu or chickenpox vaccines) within 4 weeks before the first dose, or who are expected to receive one during the study.
• People who have had major surgery or a serious physical injury within 4 weeks before the first dose.
• People who still have significant side effects (above a mild level) from previous cancer treatments, except for hair loss or nerve-related side effects from platinum-based chemotherapy.
• People with serious heart conditions, including moderate-to-severe heart failure, history of heart attack or chest pain from heart disease, significant irregular heartbeats, or a reduced heart pumping function (below 50%), or abnormal heart readings on an ECG.
• People with poorly controlled diabetes (high fasting blood sugar levels) or poorly controlled high blood pressure.
• People with an active infection or an unexplained fever in the 48 hours before the first dose, or who have taken antibiotic medicines in the week before signing the consent form.
• People with active hepatitis B or C infections, known HIV, or AIDS.
• People who are pregnant or breastfeeding.
• People who have taken part in another clinical drug trial within 4 weeks before the first dose, or who are currently enrolled in another treatment-based trial.
• People who, in the opinion of the trial doctor, have any other medical or personal circumstances that could make participation unsafe or unsuitable.

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