Abdominal CancerPhase 1LPSNCT05751837
Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal Tumors
A Phase 1 study testing Lipopolysaccharide in people with Abdominal Cancer and Malignancy, run by Patrick Wagner, MD, FACS at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Abdominal Cancer, Malignancy
- What is being tested?
- Lipopolysaccharide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Mar 2023to 30 May 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Must be able to read and understand English and consent for themselves
Who cannot join
- 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:
Show all 11Show fewer
- AST/SGOT > 1.5 times the upper limit of normal ALT/SGPT > 1.5 times the upper limit of normal Total bilirubin > 1.5 times the upper limit of normal Creatinine > 1.5 times the upper limit of normal Hemoglobin < 9 gm/dL White blood cell count < 3,000/ mm3 Platelet count < 70,000/mm3 INR >1.5 times the upper limit of normal PTT >1.5 times the upper limit of normal
- History of allergic reaction to the investigational agent carrier solution.
- Medical contra-indication or allergic reaction to acetaminophen or NSAIDs.
- Participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- Adverse events from prior therapy that have not resolved to CTCAE version 5 grade < and equal to1 prior to enrollment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Allegheny Health Network Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Allegheny Health Network West Penn Hospital
Pittsburgh, Pennsylvania, 15224
About this study
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.
Read the detailed description
Immunotherapy for advanced cancers of the abdomen can be quite effective, but not all tumors are responsive to this type of treatment. There is intense interest in new methods to convert non-responsive tumors into responsive tumors. One such method is to inject chemical constituents of micro-organisms into tumors in order to stimulate the immune system to recognize the tumor as foreign and mount an immune response to treatment.
- Conditions
- Abdominal Cancer, Malignancy
- Being tested
- Lipopolysaccharide
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipopolysaccharideBiological
Also called LPS; E. coli 0113
One tumor will be injected with 1 ug LPS (investigational drug) over approximately one minute
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Injection of Lipopolysaccharide into one abdominal tumor Receives: Biological: Lipopolysaccharide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number, nature and severity of adverse events as assessed by CTCAE v 4.0 will be determined in patients undergoing injection of bacterial-derived immunotherapeutic toll receptor agonist (LPS) instilled via direct injection into intra-abdominal tumors during laparoscopic surgery.
Measured: 30 Days
Secondary outcomes (1)
Alteration in Cellular and Soluble Immune Biomarkers in Injected Tumors
Changes in intra-tumoral leukocyte subgroup densities and soluble immune biomarker concentrations will be assessed in injected tumors and compared against non-injected tumors.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start16 Mar 2023
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Abdominal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, open label, comparative, phase I safety and feasibility study, with correlative translational studies
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patrick Wagner, MD, FACS
- Sponsor type
- University, hospital or other
- Collaborators
- List Biological Laboratories, Inc
- Responsible party
- Sponsor-investigator, Patrick Wagner, MD, FACS, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751837
- Sponsor's protocol ID
- 2022-263
- Acronym
- LPS
- Status last verified
- Jun 2026
- First submitted
- 2 Feb 2023
- Last updated
- 15 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No identifiable data will be used for future study without first obtaining IRB approval. The investigator will obtain a data use agreement between the provider (the PI) of the data and any recipient researchers before sharing data.
Publications
Lewis C, Dadgar N, Najafi M, Park H, Sherry C, Lucas A, Zaidi A, Xiao K, Omstead A, Donnenberg A, Bartlett DL. Intra-tumoral immunomodulatory therapy for advanced abdominal cancers using lipopolysaccharide: The Regional Immuno-Oncology Trial-1 (RIOT-1) protocol (NCT05751837). Surgical Oncology Insight. 2024 Jun 1;1(2):100042.
Shetab Boushehri MA, Lamprecht A. TLR4-Based Immunotherapeutics in Cancer: A Review of the Achievements and Shortcomings. Mol Pharm. 2018 Nov 5;15(11):4777-4800. doi: 10.1021/acs.molpharmaceut.8b00691. Epub 2018 Oct 3.
PubMed 30226786Oblak A, Jerala R. Toll-like receptor 4 activation in cancer progression and therapy. Clin Dev Immunol. 2011;2011:609579. doi: 10.1155/2011/609579. Epub 2011 Nov 3.
PubMed 22110526Berendt MJ, North RJ, Kirstein DP. The immunological basis of endotoxin-induced tumor regression. Requirement for a pre-existing state of concomitant anti-tumor immunity. J Exp Med. 1978 Dec 1;148(6):1560-9. doi: 10.1084/jem.148.6.1560.
PubMed 309922Chicoine MR, Won EK, Zahner MC. Intratumoral injection of lipopolysaccharide causes regression of subcutaneously implanted mouse glioblastoma multiforme. Neurosurgery. 2001 Mar;48(3):607-14; discussion 614-5. doi: 10.1097/00006123-200103000-00032.
PubMed 11270552Mariani CL, Rajon D, Bova FJ, Streit WJ. Nonspecific immunotherapy with intratumoral lipopolysaccharide and zymosan A but not GM-CSF leads to an effective anti-tumor response in subcutaneous RG-2 gliomas. J Neurooncol. 2007 Dec;85(3):231-40. doi: 10.1007/s11060-007-9415-2. Epub 2007 Jun 14.
PubMed 17568998Goto S, Sakai S, Kera J, Suma Y, Soma GI, Takeuchi S. Intradermal administration of lipopolysaccharide in treatment of human cancer. Cancer Immunol Immunother. 1996 May;42(4):255-61. doi: 10.1007/s002620050279.
PubMed 8665574Engelhardt R, Mackensen A, Galanos C. Phase I trial of intravenously administered endotoxin (Salmonella abortus equi) in cancer patients. Cancer Res. 1991 May 15;51(10):2524-30.
PubMed 2021932van Lier D, Geven C, Leijte GP, Pickkers P. Experimental human endotoxemia as a model of systemic inflammation. Biochimie. 2019 Apr;159:99-106. doi: 10.1016/j.biochi.2018.06.014. Epub 2018 Jun 22.
PubMed 29936295Fong YM, Marano MA, Moldawer LL, Wei H, Calvano SE, Kenney JS, Allison AC, Cerami A, Shires GT, Lowry SF. The acute splanchnic and peripheral tissue metabolic response to endotoxin in humans. J Clin Invest. 1990 Jun;85(6):1896-904. doi: 10.1172/JCI114651.
PubMed 2347917Calvano SE, Coyle SM. Experimental human endotoxemia: a model of the systemic inflammatory response syndrome? Surg Infect (Larchmt). 2012 Oct;13(5):293-9. doi: 10.1089/sur.2012.155. Epub 2012 Oct 16.
PubMed 23072275Vila G, Riedl M, Resl M, van der Lely AJ, Hofland LJ, Clodi M, Luger A. Systemic administration of oxytocin reduces basal and lipopolysaccharide-induced ghrelin levels in healthy men. J Endocrinol. 2009 Oct;203(1):175-9. doi: 10.1677/JOE-09-0227. Epub 2009 Jul 8.
PubMed 19587265Hudgins LC, Parker TS, Levine DM, Gordon BR, Saal SD, Jiang XC, Seidman CE, Tremaroli JD, Lai J, Rubin AL. A single intravenous dose of endotoxin rapidly alters serum lipoproteins and lipid transfer proteins in normal volunteers. J Lipid Res. 2003 Aug;44(8):1489-98. doi: 10.1194/jlr.M200440-JLR200. Epub 2003 May 16.
PubMed 12754273Mehta RS, Nishihara R, Cao Y, Song M, Mima K, Qian ZR, Nowak JA, Kosumi K, Hamada T, Masugi Y, Bullman S, Drew DA, Kostic AD, Fung TT, Garrett WS, Huttenhower C, Wu K, Meyerhardt JA, Zhang X, Willett WC, Giovannucci EL, Fuchs CS, Chan AT, Ogino S. Association of Dietary Patterns With Risk of Colorectal Cancer Subtypes Classified by Fusobacterium nucleatum in Tumor Tissue. JAMA Oncol. 2017 Jul 1;3(7):921-927. doi: 10.1001/jamaoncol.2016.6374.
PubMed 28125762Kiers D, Leijte GP, Gerretsen J, Zwaag J, Kox M, Pickkers P. Comparison of different lots of endotoxin and evaluation of in vivo potency over time in the experimental human endotoxemia model. Innate Immun. 2019 Jan;25(1):34-45. doi: 10.1177/1753425918819754.
PubMed 30782041
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal Tumors
- ClinicalTrials.gov ID
- NCT05751837
- Acronym / sponsor ID
- LPS / 2022-263
- Conditions
- Abdominal Cancer, Malignancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Patrick Wagner, MD, FACSUniversity, hospital or other
- Collaborators
- List Biological Laboratories, Inc
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 2 Mar 2023 (actual)
- Results
- Posted 15 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Immunotherapy for advanced cancers of the abdomen can be quite effective, but not all tumors are responsive to this type of treatment. There is intense interest in new methods to convert non-responsive tumors into responsive tumors. One such method is to inject chemical constituents of micro-organisms into tumors in order to stimulate the immune system to recognize the tumor as foreign and mount an immune response to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, open label, comparative, phase I safety and feasibility study, with correlative translational studies
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Biological: LipopolysaccharideInjection of Lipopolysaccharide into one abdominal tumor |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LipopolysaccharideAlso: LPS; E. coli 0113One tumor will be injected with 1 ug LPS (investigational drug) over approximately one minute | Biological | Treatment Arm |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 30 Days
The number, nature and severity of adverse events as assessed by CTCAE v 4.0 will be determined in patients undergoing injection of bacterial-derived immunotherapeutic toll receptor agonist (LPS) instilled via direct injection into intra-abdominal tumors during laparoscopic surgery.
1 secondary outcome
Alteration in Cellular and Soluble Immune Biomarkers in Injected Tumors
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundLewis C, Dadgar N, Najafi M, Park H, Sherry C, Lucas A, Zaidi A, Xiao K, Omstead A, Donnenberg A, Bartlett DL. Intra-tumoral immunomodulatory therapy for advanced abdominal cancers using lipopolysaccharide: The Regional Immuno-Oncology Trial-1 (RIOT-1) protocol (NCT05751837). Surgical Oncology Insight. 2024 Jun 1;1(2):100042.
- Background: PubMed 30226786Shetab Boushehri MA, Lamprecht A. TLR4-Based Immunotherapeutics in Cancer: A Review of the Achievements and Shortcomings. Mol Pharm. 2018 Nov 5;15(11):4777-4800. doi: 10.1021/acs.molpharmaceut.8b00691. Epub 2018 Oct 3.
- Background: PubMed 22110526Oblak A, Jerala R. Toll-like receptor 4 activation in cancer progression and therapy. Clin Dev Immunol. 2011;2011:609579. doi: 10.1155/2011/609579. Epub 2011 Nov 3.
- Background: PubMed 309922Berendt MJ, North RJ, Kirstein DP. The immunological basis of endotoxin-induced tumor regression. Requirement for a pre-existing state of concomitant anti-tumor immunity. J Exp Med. 1978 Dec 1;148(6):1560-9. doi: 10.1084/jem.148.6.1560.
- Background: PubMed 11270552Chicoine MR, Won EK, Zahner MC. Intratumoral injection of lipopolysaccharide causes regression of subcutaneously implanted mouse glioblastoma multiforme. Neurosurgery. 2001 Mar;48(3):607-14; discussion 614-5. doi: 10.1097/00006123-200103000-00032.
- Background: PubMed 17568998Mariani CL, Rajon D, Bova FJ, Streit WJ. Nonspecific immunotherapy with intratumoral lipopolysaccharide and zymosan A but not GM-CSF leads to an effective anti-tumor response in subcutaneous RG-2 gliomas. J Neurooncol. 2007 Dec;85(3):231-40. doi: 10.1007/s11060-007-9415-2. Epub 2007 Jun 14.
- Background: PubMed 8665574Goto S, Sakai S, Kera J, Suma Y, Soma GI, Takeuchi S. Intradermal administration of lipopolysaccharide in treatment of human cancer. Cancer Immunol Immunother. 1996 May;42(4):255-61. doi: 10.1007/s002620050279.
- Background: PubMed 2021932Engelhardt R, Mackensen A, Galanos C. Phase I trial of intravenously administered endotoxin (Salmonella abortus equi) in cancer patients. Cancer Res. 1991 May 15;51(10):2524-30.
- Background: PubMed 29936295van Lier D, Geven C, Leijte GP, Pickkers P. Experimental human endotoxemia as a model of systemic inflammation. Biochimie. 2019 Apr;159:99-106. doi: 10.1016/j.biochi.2018.06.014. Epub 2018 Jun 22.
- Background: PubMed 2347917Fong YM, Marano MA, Moldawer LL, Wei H, Calvano SE, Kenney JS, Allison AC, Cerami A, Shires GT, Lowry SF. The acute splanchnic and peripheral tissue metabolic response to endotoxin in humans. J Clin Invest. 1990 Jun;85(6):1896-904. doi: 10.1172/JCI114651.
- Background: PubMed 23072275Calvano SE, Coyle SM. Experimental human endotoxemia: a model of the systemic inflammatory response syndrome? Surg Infect (Larchmt). 2012 Oct;13(5):293-9. doi: 10.1089/sur.2012.155. Epub 2012 Oct 16.
- Background: PubMed 19587265Vila G, Riedl M, Resl M, van der Lely AJ, Hofland LJ, Clodi M, Luger A. Systemic administration of oxytocin reduces basal and lipopolysaccharide-induced ghrelin levels in healthy men. J Endocrinol. 2009 Oct;203(1):175-9. doi: 10.1677/JOE-09-0227. Epub 2009 Jul 8.
- Individual participant dataSharing planned: No. No identifiable data will be used for future study without first obtaining IRB approval. The investigator will obtain a data use agreement between the provider (the PI) of the data and any recipient researchers before sharing data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lipopolysaccharide in people with Abdominal Cancer and Malignancy, run by Patrick Wagner, MD, FACS at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05751837, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.