Intraperitoneal LSTA1 in CRS-HIPEC (NCT06216561) | Clinical Trial Compass
WithdrawnPhase 1
Intraperitoneal LSTA1 in CRS-HIPEC
Stopped: closed early due to low (0) accrual
United States0Started 2023-11-30
Plain-language summary
This Study is designed to test an investigational product (IP) called LSTA1 (Study drug). LSTA1 is a drug designed to improve the delivery of anti-cancer treatments, such as chemotherapy. Improved delivery of chemotherapy may result in improved anti-cancer effects when given with hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal metastases. Participants will be randomized to receive LSTA1 with HIPEC or HIPEC alone (without LSTA1) at the time of surgery.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Provision of signed and dated informed consent form.
✓. Stated willingness to comply with all study procedures and availability for the duration of the study.
✓. Participants must have histologically confirmed non-mucinous (\< 50% mucin) colorectal, ovarian, or appendiceal carcinoma with peritoneal metastases who are candidates for (cytoreductive surgery and CRS-HIPEC and have at least one peritoneal tumor nodule \> 5 mm (as determined by routine preoperative imaging and confirmed by intraoperative assessment).
✓. Eligible and intended to undergo CRS-HIPEC per the investigators. This includes assessment of axial imaging (computed tomography, magnetic resonance imaging, positron emission tomography scan) of chest, abdomen, and pelvis, within 30 days of screening, which reveals peritoneal metastases amenable to complete cytoreduction per the investigators (i.e. limited small bowel/mesenteric metastases), lack of extra-peritoneal metastases (including intra-hepatic and pulmonary metastases), and lack of untreated biliary, gastrointestinal, and urologic obstruction.
✓. Age ≥ 18 years.
✓. Eastern Cooperative Oncology Group (ECOG) performance status \< 2.
✓. Women of child-bearing potential with negative pregnancy test prior to undergoing CRS-HIPEC.
✓. Adequate contraception for participants able to cause a pregnancy:
Exclusion criteria
✕. Participants who do not receive HIPEC at the time of CRS.
✕
What they're measuring
1
Adverse events of interest (AE-I)
Timeframe: postoperatively from the date of CRS-HIPEC to date of discharge (typically 1-2 weeks)
. Any major surgery or irradiation within 30 days prior to prior to planned date of CRS-HIPEC.
✕. Active infection (viral, fungal, or bacterial) requiring systemic therapy.
✕. Known active hepatitis B virus (HBV), hepatitis C virus (HCV), tuberculosis, or human immunodeficiency virus (HIV) infection.
✕. History of allogeneic tissue/solid organ transplant.
✕. History or clinical evidence of central nervous system (CNS) metastases without exceptions
✕. History of allergic reactions attributed to compounds of similar chemical or biologic composition to LSTA1 or other agents used in the study, including those discovered by other ongoing studies of LSTA1 or other agents used in the study.
✕. Existing venous thromboembolism at the time of CRS-HIPEC.