Phase
Condition
Colorectal Cancer
Colon Cancer; Rectal Cancer
Rectal Cancer
Treatment
CRS-HIPEC + LSTA1
CRS-HIPEC alone
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for theduration of the study.
Participants must have histologically confirmed non-mucinous (< 50% mucin)colorectal, ovarian, or appendiceal carcinoma with peritoneal metastases who arecandidates for (cytoreductive surgery and CRS-HIPEC and have at least one peritonealtumor nodule > 5 mm (as determined by routine preoperative imaging and confirmed byintraoperative assessment).
Eligible and intended to undergo CRS-HIPEC per the investigators. This includesassessment of axial imaging (computed tomography, magnetic resonance imaging,positron emission tomography scan) of chest, abdomen, and pelvis, within 30 days ofscreening, which reveals peritoneal metastases amenable to complete cytoreductionper the investigators (i.e. limited small bowel/mesenteric metastases), lack ofextra-peritoneal metastases (including intra-hepatic and pulmonary metastases), andlack 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 undergoingCRS-HIPEC.
Adequate contraception for participants able to cause a pregnancy:
Exclusion
Exclusion Criteria:
Participants who do not receive HIPEC at the time of CRS.
Any major surgery or irradiation within 30 days prior to prior to planned date ofCRS-HIPEC.
Active infection (viral, fungal, or bacterial) requiring systemic therapy.
Known active hepatitis B virus (HBV), hepatitis C virus (HCV), tuberculosis, orhuman immunodeficiency virus (HIV) infection.
History of allogeneic tissue/solid organ transplant.
History or clinical evidence of central nervous system (CNS) metastases withoutexceptions
History of allergic reactions attributed to compounds of similar chemical orbiologic composition to LSTA1 or other agents used in the study, including thosediscovered by other ongoing studies of LSTA1 or other agents used in the study.
Existing venous thromboembolism at the time of CRS-HIPEC.
Severe or uncontrolled medical disorder that would, in the investigator's opinion,impair ability to undergo CRS-HIPEC and receive study treatment. This includes, butis not limited to the following laboratory values and other parameters within 30days prior to planned date of CRS-HIPEC:
Platelets < 100,000/mm3
White blood cell count < 3000/ mm3
Absolute neutrophil count < 1,500/mm3
Serum albumin < 2.5 g/L
Alanine transaminase (ALT) and aspartate aminotransferase (AST) > 2.5 x upperlimit of normal (ULN) in the absence of liver metastases or > 5 x ULN in thepresence of liver metastases
Bilirubin > 1.5 x ULN
Glomerular Filtration Rate (per Modification of Diet in Renal Disease equation) < 30 mL/min
Hemoglobin < 9.0 g/dL (drawn 24 hours after a transfusion, if relevant)
International normalised ratio (INR) > 2.0 (for patients not receivingtherapeutic anticoagulation)
Adequate respiratory and cardiac function (PaO2 ≥ 60 mm Hg or oxygen saturation ≥ 92% on room air, and 12-lead electrocardiogram (ECG) with normal tracing orQT interval < 470 ms)
Participants who are pregnant or nursing.
Study Design
Study Description
Connect with a study center
University of California San Diego
La Jolla, California 92093
United StatesSite Not Available

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