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WithdrawnNCT06216561Updated Aug 20, 2024

Intraperitoneal LSTA1 in CRS-HIPEC

A Phase 1 interventional study of CRS-HIPEC + LSTA1 and CRS-HIPEC alone in Colorectal Cancer, Ovarian Carcinoma and Appendix Cancer, sponsored by University of California, San Diego. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-20.

Sponsored by University of California, San Diego · Phase 1, Interventional, and Treatment

Why this study was withdrawn
closed early due to low (0) accrual
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Given the high recurrence and disease-related mortality in patients with peritoneal metastases from appendiceal, colorectal, and ovarian cancer after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC), use of an agent to improve operative tumor delivery of co-administered anticancer drugs during HIPEC would potentially have significant impact on oncologic outcomes.

Safety of LSTA1 has been demonstrated in the context of metastatic pancreatic cancer when administered intravenously with cytotoxic chemotherapy, but the investigators wish to determine its safety and potential efficacy when administered intraperitoneally with HIPEC in patients with peritoneal metastases from appendiceal, colorectal, and ovarian cancer.

02

Conditions studied

  • Colorectal Cancer
  • Ovarian Carcinoma
  • Appendix Cancer
  • Peritoneal Metastases
03

In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

Browse Colorectal Neoplasms studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 975 studies on the registry; 196 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 71 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Provision of signed and dated informed consent form.
  2. Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. 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).
  4. 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.
  5. Age ≥ 18 years.
  6. Eastern Cooperative Oncology Group (ECOG) performance status \< 2.
  7. Women of child-bearing potential with negative pregnancy test prior to undergoing CRS-HIPEC.
  8. Adequate contraception for participants able to cause a pregnancy:

Exclusion criteria

Exclusion Criteria:

  1. Participants who do not receive HIPEC at the time of CRS.
  2. Any major surgery or irradiation within 30 days prior to prior to planned date of CRS-HIPEC.
  3. Active infection (viral, fungal, or bacterial) requiring systemic therapy.
  4. Known active hepatitis B virus (HBV), hepatitis C virus (HCV), tuberculosis, or human immunodeficiency virus (HIV) infection.
  5. History of allogeneic tissue/solid organ transplant.
  6. History or clinical evidence of central nervous system (CNS) metastases without exceptions
  7. 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.
  8. Existing venous thromboembolism at the time of CRS-HIPEC.
  9. Severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to undergo CRS-HIPEC and receive study treatment. This includes, but is not limited to the following laboratory values and other parameters within 30 days prior to planned date of CRS-HIPEC:

    1. Platelets \< 100,000/mm3
    2. White blood cell count \< 3000/ mm3
    3. Absolute neutrophil count \< 1,500/mm3
    4. Serum albumin \< 2.5 g/L
    5. Alanine transaminase (ALT) and aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN) in the absence of liver metastases or > 5 x ULN in the presence of liver metastases
    6. Bilirubin > 1.5 x ULN
    7. Glomerular Filtration Rate (per Modification of Diet in Renal Disease equation) \< 30 mL/min
    8. Hemoglobin \< 9.0 g/dL (drawn 24 hours after a transfusion, if relevant)
    9. International normalised ratio (INR) > 2.0 (for patients not receiving therapeutic anticoagulation)
    10. Adequate respiratory and cardiac function (PaO2 ≥ 60 mm Hg or oxygen saturation ≥ 92% on room air, and 12-lead electrocardiogram (ECG) with normal tracing or QT interval \< 470 ms)
  10. Participants who are pregnant or nursing.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    CRS-HIPEC + LSTA1

    Experimental Arm

    Drug: CRS-HIPEC + LSTA1

  • Active comparator
    CRS-HIPEC alone

    Control Arm

    Procedure: CRS-HIPEC alone

Interventions

  • DrugCRS-HIPEC + LSTA1

    LSTA1 given with hyperthermic intraperitoneal chemotherapy (HIPEC) at time of cytoreductive surgery (CRS)

    Also known as: Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) + Advanced Solid TumorsCertepetide (LSTA1)

  • ProcedureCRS-HIPEC alone

    Hyperthermic intraperitoneal chemotherapy (HIPEC) alone (without LSTA1) at time of cytoreductive surgery (CRS)

06

What researchers measure

Primary outcomes

  1. Adverse events of interest (AE-I)

    The proportion of subjects experiencing an inpatient adverse event of interest (AE-I; gastrointestinal fistula/leak, neutropenia, intra-abdominal abscess, venous thromboembolism, mortality)

    Time frame: postoperatively from the date of CRS-HIPEC to date of discharge (typically 1-2 weeks)

  2. Drug concentration in tumor

    Total drug content in tumor, divided by total tumor mass

    Time frame: at time of surgery

Secondary outcomes

  1. Progression-Free Survival and Overall Survival

    Time (in months) from randomization to time of progression or death due to any cause, whichever occurs first (PFS), or to time of death due to any cause (OS).

    Time frame: 5 years

  2. Adverse Events (AEs)

    Incidence of any adverse events (AEs) by grade and system organ class using CTCAE v5.0 up to 30 days from the date of CRS-HIPEC.

    Time frame: 30 Days

07

Study locations

1 site
  • University of California San Diego
    La Jolla, California 92093, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06216561
Responsible party
Joel Baumgartner (Associate Professor of Surgery, University of California, San Diego) — Principal investigator
First posted
Jan 22, 2024
Start date
Nov 30, 2023
Primary completion
Jun 24, 2024
Completion
Jun 24, 2024
Last update
Aug 20, 2024

Study contacts

Joel Baumgartner
principal investigator · University of California, San Diego

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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