Phase 1 Stomach 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 informed consent, or whose legal representative has done so on their behalf.
• People who have been confirmed by biopsy or tissue testing to have ovarian, uterine, gastric, appendiceal, or colorectal cancer that has spread to the lining of the abdomen (called peritoneal spread).
• People who have previously received chemotherapy delivered directly into the abdominal cavity are still permitted to join.
• People whose general health and ability to carry out daily activities meets a standard score of 2 or below on a medical scale (meaning they are at least partly active and able to care for themselves).
• People whose blood test results meet the required levels for white blood cells, platelets, haemoglobin, liver function, kidney function, and other markers (the trial site will assess these).
• People who do not have any medical reason that would make a keyhole surgery (laparoscopy) unsafe for them.
• People whose cancer spread in the abdomen is visible on a scan or during keyhole surgery, even if it cannot be measured by standard criteria.
• People whose cancer has grown or worsened after at least one standard chemotherapy treatment (applies to Arms 1 and 2), or whose cancer has been stable or responding after at least 4 months of first-line chemotherapy (applies to Arm 3).
• People with a history of hepatitis B who have an undetectable virus level while on appropriate treatment.
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have an undetectable virus level.
• People who are able and willing to use effective contraception during the study and for up to 12 weeks after the last dose of the study treatment (applies to women who could become pregnant and men whose partners could become pregnant).
• People whose keyhole surgery findings show that the abdominal aerosol treatment can be safely performed, there is no sign of an imminent bowel blockage, there is less than 5 litres of fluid in the abdomen, and the person is not a candidate for a different surgical treatment (HIPEC) — all of these conditions must be met before the treatment can proceed.

Who may not be able to join:

• People with gastric, colorectal, or appendiceal cancer where the cancer has spread to areas outside the abdominal lining (applies to Arms covering these cancer types).
• People in Arm 1 (ovarian, uterine, or gastric) who have already received the maximum allowable lifetime doses of certain chemotherapy drugs known as anthracyclines (such as doxorubicin or epirubicin).
• People in Arm 2 or 3 (colorectal/appendiceal) who are known to have a genetic enzyme deficiency that makes it harder for the body to process a certain type of chemotherapy drug (called DPD deficiency).
• People in Arm 2 or 3 who have a bowel blockage that requires a stomach tube, a feeding tube inserted through the skin, or who are receiving all nutrition through a drip into the bloodstream.
• People in Arm 2 who have had a serious allergic or severe unexpected reaction to platinum-based chemotherapy drugs in the past.
• People in Arm 2 or 3 who have not fully recovered from side effects of previous cancer treatment (with some exceptions, such as hair loss or mild nerve-related symptoms in the hands or feet).
• People in Arm 2 or 3 whose life expectancy is estimated at less than 6 months.
• People in Arm 2 who have had chemotherapy or surgery within the 4 weeks before joining (or 6 weeks if the previous treatment included bevacizumab).
• People in Arm 3 who have had chemotherapy or surgery within the 2 weeks before joining (or 6 weeks if previous treatment included bevacizumab).
• People in Arm 2 or 3 who have previously had a life-threatening allergic reaction (anaphylaxis) to the chemotherapy drug being used in the trial.
• People in Arm 2 or 3 who are currently receiving any other experimental or investigational cancer treatment.
• People in Arm 2 or 3 whose abdominal fluid (ascites) is caused by severe liver cirrhosis, or who have a blood clot in the portal vein of the liver.
• People in Arm 2 or 3 who would require bowel removal surgery at the same time as the trial procedure.
• People in Arm 2 or 3 with serious uncontrolled medical conditions, including active infection, severe heart failure, recent heart attack, severe irregular heartbeat, severe kidney or liver problems, or severely low blood counts.
• People in Arm 2 or 3 with a weakened immune system due to a known immune disease or medications that suppress the immune system.
• People in Arm 2 or 3 who are pregnant.
• People in Arm 2 or 3 with a psychiatric illness or personal circumstances that would make it difficult to follow the trial requirements.
• People in Arm 2 or 3 with serious heart conditions (classified as NYHA Class 3 or 4), or who have had a heart attack, severe diabetic episode, or a lung condition requiring hospitalisation in the past 6 months.
• People in Arm 2 or 3 who have had a serious infection requiring antibiotics within 72 hours before starting the study treatment.
• People in Arm 2 or 3 who have previously received chemotherapy delivered as a mist or aerosol inside the abdomen.
• People in Arm 3 whose cancer has grown or worsened on both first-line and second-line chemotherapy.
• People in Arm 3 who needed significant dose reductions of chemotherapy due to effects on blood cell counts.
• People in Arm 3 who were unable to tolerate standard doses of specific chemotherapy drugs (5-FU or irinotecan) due to side effects requiring major dose reductions or treatment breaks of more than one week.

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