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CRS-HIPEC + LSTA1 for Ovarian Cancer

Phase 1

Recruiting

Led By Joel Baumgartner

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have histologically confirmed non-mucinous (< 50% mucin) colorectal, ovarian, or appendiceal carcinoma with peritoneal metastases who are candidates for cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) and have at least one peritoneal tumor nodule > 5 mm

Eligible and intended to undergo CRS-HIPEC per the investigators, including assessment of axial imaging within 30 days of screening, which reveals peritoneal metastases amenable to complete cytoreduction per the investigators, lack of extra-peritoneal metastases, and lack of untreated biliary, gastrointestinal, and urologic obstruction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is testing a new drug called LSTA1, which is designed to help improve the effectiveness of chemotherapy for treating cancer. The drug will be given to patients with peritoneal metastases,

Who is the study for?

This trial is for individuals with ovarian, appendiceal, or colorectal cancer that has spread to the lining of the abdomen. Participants must meet certain health standards but specific inclusion and exclusion criteria are not listed.Check my eligibility

What is being tested?

The study is testing a new drug called LSTA1 designed to enhance chemotherapy delivery during a procedure combining surgery with heated chemo (CRS-HIPEC). Patients will be randomly assigned to receive either LSTA1 with HIPEC or just HIPEC alone.See study design

What are the potential side effects?

Potential side effects are not detailed here, but may include typical reactions related to chemotherapy and surgical procedures such as pain, infection risk, nausea, fatigue, and complications from anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have colorectal, ovarian, or appendiceal cancer with specific tumor spread, and am a candidate for certain surgeries.

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I am eligible for a specific surgery to remove cancer in my abdomen, as decided by my doctors.

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I am 18 years old or older.

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I can do all my daily activities without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse events of interest (AE-I)

Drug concentration in tumor

Secondary outcome measures

Adverse Events (AEs)

Progression-Free Survival and Overall Survival

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CRS-HIPEC + LSTA1Experimental Treatment1 Intervention

Experimental Arm

Group II: CRS-HIPEC aloneActive Control1 Intervention

Control Arm

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,122 Previous Clinical Trials

1,521,023 Total Patients Enrolled

1 Trials studying Ovarian Cancer

200 Patients Enrolled for Ovarian Cancer

Joel BaumgartnerPrincipal InvestigatorUniversity of California, San Diego

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the safety profile of CRS-HIPEC + LSTA1 in relation to patient well-being?

"Since this trial is in Phase 1, the safety of CRS-HIPEC + LSTA1 has been assigned a score of 1. This indicates that there is limited data available regarding its safety and efficacy."

Answered by AI

Are there any available positions for patients in this ongoing clinical trial?

"According to the information available on clinicaltrials.gov, this trial is currently accepting participants. The original posting date was November 30th, 2023, and the most recent update occurred on January 16th, 2024."

Answered by AI

What is the current capacity for patient enrollment in this clinical trial?

"Indeed, the information available on clinicaltrials.gov indicates that this particular clinical trial is actively seeking eligible candidates. The initial posting of the trial occurred on November 30th, 2023 and it was last edited on January 16th, 2024. This study aims to enroll a total of 21 participants from a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intraperitoneal LSTA1 in CRS-HIPEC

Joel Baumgartner 2023. "Intraperitoneal LSTA1 in CRS-HIPEC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06216561.

All > Colorectal Cancer San Diego