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Procedure

Blood Purification for Pancreatic Cancer

N/A
Recruiting
Led By Sanja Ilic, MD, MS, RAC
Research Sponsored by ExThera Medical Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients ≥ 18 years of age with metastatic pancreatic ductal carcinoma who experienced disease progression or not tolerating specific regimens
Female patients must have a negative serum pregnancy test at Screening, and negative urine pregnancy test at baseline
Must not have
Uncontrolled hypertension despite optimal management
Renal failure requiring dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up [time frame 60 days]
Awards & highlights

Summary

"This trial aims to test a new blood purification procedure for people with advanced pancreatic cancer that has not responded to standard treatments. The trial will be conducted at sites experienced in blood purification and pancreatic cancer care.

Who is the study for?
This trial is for adults over 18 with a specific type of pancreatic cancer called 'pancreatobiliary type' adenocarcinoma. They must have tried other treatments that didn't work and have at least 5 cancer cells per microliter in their blood. Participants should be fairly active, meaning they can take care of themselves but might not be able to do heavy physical work.
What is being tested?
The OSCAR I STUDY is testing the ONCObind (Onco-Seraph) 100 Filter, which is a new procedure designed to clean the blood from certain cancer cells in patients with advanced pancreatic cancer who haven't responded well to standard treatments.
What are the potential side effects?
Since this study involves an extracorporeal blood purification process, potential side effects may include reactions related to the filter or procedure such as infection risk, bleeding complications, or issues related to blood pressure changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 and my pancreatic cancer has worsened or I can't tolerate my current treatment.
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I am a woman and have tested negative for pregnancy.
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I can take care of myself but might not be able to do heavy physical work.
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I am either not able to become pregnant or I am using effective birth control.
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I am a man who is either surgically sterile or using contraception.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My high blood pressure is not controlled despite treatment.
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I am on dialysis for kidney failure.
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I am currently dealing with a serious infection that isn't under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~[time frame 60 days]
This trial's timeline: 3 weeks for screening, Varies for treatment, and [time frame 60 days] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in CTC Concentration
Survival Follow-Up
Secondary study objectives
Capacity for the Onco-Seraph 100 Filter to Remove Circulating Tumor Cells
Incidence of Procedure-Emergent Adverse Events Assessed by NCI CTCAE v5.0
Incidence of Procedure-Emergent Serious Adverse Events Assessed by NCI CTCAE v5.0

Trial Design

1Treatment groups
Experimental Treatment
Group I: ONCObind (Onco-Seraph) 100 Filter is a single useExperimental Treatment1 Intervention
The Onco-Seraph 100 Filter is a single use, disposable column packed with ultra-high molecular weight polyethylene beads which have been modified to contain endpoint attached heparin on the surface. The devices are sterilized using a standard ethylene oxide cycle, following ISO 11135-1:2007. Chemical Indicator labels are located near the product label. A green label indicates that the device has been exposed to ethylene oxide gas. Onco-Seraph 100 is part of the Seraph platform technology that was also developed as an extracorporeal broad-spectrum sorbent hemoperfusion device for reduction of pathogens from the bloodstream.

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Who is running the clinical trial?

ExThera Medical CorporationLead Sponsor
5 Previous Clinical Trials
404 Total Patients Enrolled
Sanja Ilic, MD, MS, RACPrincipal InvestigatorExThera Medical
~2 spots leftby Dec 2024
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