Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal Tumors (NCT05751837) | Clinical Trial Compass
CompletedPhase 1
Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal Tumors
United States12 participantsStarted 2023-03-16
Plain-language summary
The purpose of this research study is to determine whether a sterile bacteria wall chemical, called lipopolysaccharide (LPS), can be injected safely into abdominal tumors during routine laparoscopic surgery performed as a preliminary procedure in patients who will subsequently undergo a larger planned operation to remove abdominal tumors. The researchers will biopsy the tumor before injection and then again at the time of the larger operation to assess whether any effect of the treatment can be measured.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males or females age 18 to 99 years
. Pre-menopausal women less than or equal to18 years of age must have a negative urine/serum pregnancy test prior to standard-of-care surgery and investigational treatment.
. Participants must have an advanced intra-abdominal tumor, including metastatic or recurrent, biopsy-proven, digestive tract tumors.
. Participants must have at least two index non-visceral intra-abdominal tumors that are grossly visible, \>1cm3 in volume, and amenable to biopsy and injection of investigational drug or control solution at the time of laparoscopy.
. Participants must be planning or scheduled to undergo a standard-of-care abdominal laparoscopic surgical procedure at AGH or WPH and be potentially eligible for a second, definitive operation to remove the tumor(s) pending the findings during laparoscopy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
. Must be able to read and understand English and consent for themselves
Exclusion criteria
. Pregnant or lactating females
. Investigational drug use within 30 days prior to enrollment.
. Immunosuppressive medication including corticosteroids within 30 days prior to enrollment.
. Active chemotherapy or radiotherapy within 4 weeks of investigational agent injection.
. Active infection requiring systemic therapy or causing fever \>38.1 degree C or unexplained fever \>38.1 degree C within seven days prior to investigational agent injection
. Laboratory abnormalities, drawn according to standard clinical care in anticipation of upcoming surgery outside the following limits:
. History of allergic reaction to the investigational agent carrier solution.
. Medical contra-indication or allergic reaction to acetaminophen or NSAIDs.