Phase 2 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 diagnosed with stomach cancer (gastric adenocarcinoma) that has spread to the lining of the abdomen or caused fluid build-up, and cannot be removed by surgery, or people with advanced or returned pancreatic cancer that cannot be removed by surgery
• For the Phase I part: People with stomach cancer who have already tried 3 or more chemotherapy treatments that stopped working or caused intolerable side effects, or people with pancreatic cancer who have already tried 2 or more chemotherapy treatments that stopped working or caused intolerable side effects
• For the Phase II part: People with stomach cancer who have already tried 2 or more chemotherapy treatments (including at least one involving an immune checkpoint inhibitor) that stopped working or caused intolerable side effects, or people with pancreatic cancer who have already tried 1 or more chemotherapy treatments that stopped working or caused intolerable side effects
• People for whom a port (a small medical device) can be placed in the abdomen to deliver treatment
• People with no history of serious reactions to the drug pembrolizumab (this applies only to those joining the pembrolizumab combination group)
• People whose cancer diagnosis has been confirmed through tissue or cell testing (biopsy or cytology)
• People whose tumour has been tested and found to be MSS (microsatellite stable) or pMMR (mismatch repair proficient) — meaning the cancer does not have a certain type of genetic instability (confirm with trial site if unsure what this means)
• People whose general physical functioning meets the required level at the time of joining — scored 0–2 for Phase I, or 0–1 for Phase II, on a standard medical scale called the ECOG performance scale
• People aged 20 years or older
• People whose bone marrow, heart, lungs, liver, and kidneys are functioning at a level that meets the trial's blood and organ test requirements
• People who are expected to survive for at least 3 months from the time of joining
• People who are willing and able to provide written informed consent

Who may not be able to join:

• People who have untreated cancer that has spread to the brain
• People diagnosed with cancer that has spread to the lining around the brain and spinal cord (meningeal carcinomatosis)
• People who have previously received a bone marrow or stem cell transplant from another person
• People who have taken part in another clinical trial and received an experimental treatment or used experimental equipment within the 30 days before giving consent to join this trial
• People who have, or are suspected to have, an active autoimmune disease (a condition where the immune system attacks the body)
• People who have been taking steroid medications (such as prednisolone at more than 10 mg/day) or other immune-suppressing drugs continuously in the 14 days before starting the trial treatment
• People who have symptomatic lung inflammation (interstitial pneumonia), or a form of lung condition that could make it difficult to detect new lung problems caused by the trial treatment on scans
• People who currently have another active cancer that requires treatment
• People who require certain treatments during the trial that are listed as incompatible with the trial (confirm with trial site for the specific list)
• People who have a history of severe allergic reactions or serious immune-related side effects from immune checkpoint inhibitor drugs
• People who have any of the following conditions: a stroke or related brain blood vessel problem with symptoms in the past 6 months; an active hole, abnormal connection, or inflammation in the digestive tract; symptomatic heart failure; a tendency to bleed; blood clots visible on scans that could cause blockages; unhealed broken bones (not including osteoporosis-related spine fractures) or serious wounds needing medical care; uncontrolled stomach or intestinal ulcers; active infections requiring intravenous antibiotics, antifungal, or antiviral drugs; or a positive HIV test
• People who have not waited long enough since their last treatment before joining — specific waiting periods apply depending on the type of prior treatment (such as 3 weeks from the last chemotherapy dose, or 2 weeks from surgery), (confirm exact waiting periods with trial site)
• People who have planned surgery on the chest or abdomen scheduled during the trial period
• People whose mental health condition is considered by the treating doctor to make participation too difficult
• Women who are pregnant, breastfeeding, currently trying to become pregnant, or unwilling to use contraception for 4 months after giving consent
• People who are allergic to antibiotics or to ingredients derived from pigs or mice
• People who the investigator determines are otherwise unable to participate safely

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