Phase 2 Mesothelioma 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 18 years of age or older
• People who have been diagnosed with malignant pleural mesothelioma (a type of cancer affecting the lining of the lungs) that cannot be surgically removed, is locally advanced (stage IIIB), has come back after previous treatment, or has spread to other parts of the body (stage IV), confirmed by a tissue sample test
• People who have at least one tumour that can be measured on a scan
• People who have not previously received any systemic (whole-body) anti-cancer treatment for advanced or metastatic disease — though people who previously received certain chemotherapy at an earlier stage may be eligible if at least 6 months have passed since that treatment ended and the disease has since progressed (confirm with trial site)
• People with brain metastases (cancer that has spread to the brain) that are either causing no symptoms or have been treated and stabilised, provided certain additional conditions are met (confirm with trial site)
• People who have received palliative radiotherapy, as long as it ended more than 7 days before the first trial treatment
• People with a general health and activity level rated 0 or 1 on a standard medical scale (meaning able to carry out everyday activities with little or no limitation)
• People whose life expectancy is expected to be more than 3 months
• People whose blood, liver, kidney, and other organ functions meet specific laboratory test thresholds (confirm with trial site for exact values)
• Women who could become pregnant must have a negative pregnancy test within 3 days before starting the trial
• People who agree to use highly effective contraception throughout the treatment period and for a set time afterwards (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 diagnosed with another cancer in the 5 years before joining the trial (with exceptions for certain fully treated skin cancers — confirm with trial site)
• People currently taking part in another interventional clinical trial, or who have received another experimental treatment or used an experimental medical device within the past 4 weeks
• People who have previously received certain immunotherapy drugs, including anti-PD-1, anti-PD-L1, anti-PD-L2, or similar treatments targeting the immune system
• People who have received certain traditional Chinese medicine or immune-modulating treatments for cancer within the past 2 weeks
• People who have had an active autoimmune disease requiring systemic medical treatment within the past 2 years (some replacement therapies, such as thyroid hormone, are not counted as exclusions — confirm with trial site)
• People who have been receiving systemic steroid medicines or other immune-suppressing medicines within the past 7 days (low-dose steroids at or below the equivalent of 10 mg/day of prednisone are permitted)
• People with pleural fluid (fluid around the lungs) or abdominal fluid that is not able to be controlled
• People who have had an organ transplant (other than a corneal transplant) or a stem cell transplant from a donor
• People known to be allergic to Sintilimab (the study drug) or any of its ingredients
• People who have difficulty taking oral (swallowed) medicines, for example due to swallowing problems, bowel surgery, chronic diarrhoea, or bowel blockage
• People with brain metastases that are causing symptoms or are not under control
• People who have coughed up significant amounts of blood (at least half a teaspoon at one time) in the 3 months before joining the trial
• People whose scans show that tumours are growing into or near large blood vessels, or who have signs of a tendency to bleed
• People who have had major surgery within the past 4 weeks, or who are expected to have major surgery during the trial
• People with severe wounds, ulcers, or fractures that have not healed
• People who have had minor surgery within 48 hours before starting the trial
• People currently taking or planning to take high-dose aspirin (more than 325 mg/day) or certain anti-inflammatory medicines that affect blood clotting, for 10 or more days around the start of the trial
• People who have recently received full-dose blood-thinning or clot-dissolving medicines for 10 or more consecutive days around the start of the trial (low-dose preventive anticoagulants may be permitted — confirm with trial site)
• People with inherited or existing bleeding disorders, clotting problems, or a history of blood clots
• People who have not yet recovered from side effects of a previous treatment (side effects must be at a mild level or back to their normal baseline, except for fatigue or hair loss)
• People known to have HIV infection (HIV 1/2 antibody positive)
• People with untreated, active hepatitis B infection (though people with certain controlled hepatitis B conditions may still be eligible — confirm with trial site)
• People with active hepatitis C infection
• People who have received a live vaccine within 30 days before starting the trial (certain inactivated vaccines may be allowed — confirm with trial site)
• Women who are pregnant or breastfeeding
• People with serious or uncontrolled health conditions, which may include:
  • Significant abnormal heart rhythm, certain heart conduction problems, or serious heart symptoms
  • Unstable chest pain (angina), heart failure, or moderate-to-severe chronic heart failure
  • A heart attack, stroke, or similar event in the past 6 months
  • High blood pressure that is not well controlled (above 140/90 mmHg)
  • A history of lung inflammation requiring steroid treatment within the past year, or currently active lung scarring or inflammation
  • Active tuberculosis
  • An active infection requiring systemic (whole-body) treatment
  • Active bowel or digestive conditions such as diverticulitis, abdominal abscess, or bowel obstruction
  • Significant liver disease such as cirrhosis or active hepatitis
  • Poorly controlled diabetes (fasting blood sugar above 10 mmol/L)
  • Significant levels of protein in the urine
  • Mental health conditions that would prevent participation in the trial
• People who, in the opinion of the trial doctors, have other serious health concerns that could affect their safety or ability to complete the trial

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