Trial Outcomes & Findings for Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal Tumors (NCT NCT05751837)
NCT ID: NCT05751837
Last Updated: 2026-06-15
Results Overview
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.
COMPLETED
PHASE1
12 participants
30 Days
2026-06-15
Participant Flow
A total of 12 patients with peritoneal metastases from gastrointestinal malignancies who met the inclusion criteria and were deemed suitable for a laparoscopy procedure and subsequent debulking surgery were enrolled.
An additional patient was enrolled based on prior workup and radiographic evidence of metastatic disease, although these findings were not consistent with intraoperative findings. The patient had small, \<1 cm peritoneal nodules and was deemed not eligible for the study.
Participant milestones
| Measure |
Participants
Patients with peritoneal metastases from gastrointestinal malignancies who met study criteria. Participants will undergo a single injection of LPS into an intra-abdominal tumor of digestive tract origin, and a control injection of a second tumor with the carrier solution only.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Participants
n=12 Participants
Patients with peritoneal metastases from gastrointestinal malignancies who met study criteria.
|
|---|---|
|
Age, Customized
Age at enrollment
|
52 Years
n=12 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=12 Participants
|
|
Primary malignancy site
Colon cancer :
|
4 Participants
n=12 Participants
|
|
Primary malignancy site
Appendiceal cancer :
|
8 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: 30 DaysThe 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.
Outcome measures
| Measure |
Post-saline M1 Macrophages
Post-saline injection M1 macrophages
|
Post-LPS M1 Macrophages
Post-LPS injection M1 macrophages
|
Treatment Arm
n=12 Participants
Patients with peritoneal metastases from gastrointestinal malignancies who met study criteria
|
Post-LPS Injection M1-like Macrophages
M1-like macrophages (CD86+/CD68+ cells) Post-LPS
|
Pre-LPS Injection CD20
CD20 Pre-LPS injection
|
Post-LPS Injection CD20
CD20 Post-LPS injection
|
Pre-LPS Injection CD68 Cells
CD68 cells Pre-LPS injection
|
Post-LPS Injection CD68 Cells
CD68 cells Post-LPS injection
|
Post-saline CD3e T Lymphocytes
CD3e T lymphocytes Post-saline injection
|
Post-LPS CD3e T Lymphocytes
CD3e T lymphocytes Post-LPS injection
|
Post-saline CD8+ Cytotoxic T Lymphocytes
CD8+ cytotoxic T lymphocytes Post-saline injection
|
Post-LPS CD8+ Cytotoxic T Lymphocytes
CD8+ cytotoxic T lymphocytes Post-LPS injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
|
—
|
—
|
0 Severe adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 daysChanges in intra-tumoral leukocyte subgroup densities and soluble immune biomarker concentrations will be assessed in injected tumors and compared against non-injected tumors.
Outcome measures
| Measure |
Post-saline M1 Macrophages
n=12 Participants
Post-saline injection M1 macrophages
|
Post-LPS M1 Macrophages
n=12 Participants
Post-LPS injection M1 macrophages
|
Treatment Arm
n=12 Participants
Patients with peritoneal metastases from gastrointestinal malignancies who met study criteria
|
Post-LPS Injection M1-like Macrophages
n=12 Participants
M1-like macrophages (CD86+/CD68+ cells) Post-LPS
|
Pre-LPS Injection CD20
n=12 Participants
CD20 Pre-LPS injection
|
Post-LPS Injection CD20
n=12 Participants
CD20 Post-LPS injection
|
Pre-LPS Injection CD68 Cells
n=12 Participants
CD68 cells Pre-LPS injection
|
Post-LPS Injection CD68 Cells
n=12 Participants
CD68 cells Post-LPS injection
|
Post-saline CD3e T Lymphocytes
n=12 Participants
CD3e T lymphocytes Post-saline injection
|
Post-LPS CD3e T Lymphocytes
n=12 Participants
CD3e T lymphocytes Post-LPS injection
|
Post-saline CD8+ Cytotoxic T Lymphocytes
n=12 Participants
CD8+ cytotoxic T lymphocytes Post-saline injection
|
Post-LPS CD8+ Cytotoxic T Lymphocytes
n=12 Participants
CD8+ cytotoxic T lymphocytes Post-LPS injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Alteration in Cellular and Soluble Immune Biomarkers in Injected Tumors
|
831.0 cells/mm²
Interval 339.7 to 1218.4
|
518.2 cells/mm²
Interval 127.8 to 918.4
|
348.9 cells/mm²
Interval 192.1 to 623.7
|
497.3 cells/mm²
Interval 106.7 to 902.3
|
1.2 cells/mm²
Interval 0.2 to 7.8
|
3.1 cells/mm²
Interval 0.9 to 7.7
|
418.5 cells/mm²
Interval 122.8 to 802.4
|
161.1 cells/mm²
Interval 65.4 to 293.6
|
149.0 cells/mm²
Interval 40.3 to 348.0
|
90.9 cells/mm²
Interval 32.4 to 328.8
|
73.0 cells/mm²
Interval 14.1 to 159.4
|
72.7 cells/mm²
Interval 15.3 to 195.8
|
Adverse Events
Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place