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Procedure

Blood Purification Procedure for Pancreatic Cancer

N/A

Waitlist Available

Led By Sanja Ilic, M.D., M.S., 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 must be ≥ 18 years of age with specific criteria for mPDAC and mCRC cohorts

Patients must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) scores of 2 or less

Must not have

Hemodynamic instability and inability to tolerate extracorporeal therapy

Uncontrolled hypertension despite optimal management (systolic blood pressure >180mmHg)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60, 120, 180 and 210 days

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a new blood purification procedure for patients with advanced pancreatic or colorectal cancer who have not responded to standard treatments. The study will evaluate the safety and potential effectiveness of the procedure. Participants

Who is the study for?

Adults over 18 with advanced pancreatic cancer or colorectal cancer that's not responding to treatment. They must have a certain number of tumor cells in their blood and be able to perform daily activities with minimal assistance (ECOG PS ≤2).

What is being tested?

The trial is testing ONCObind, a new procedure for filtering out tumor cells from the blood. Participants will be divided into two groups based on their type of cancer, but there won't be any comparison group receiving a placebo.

What are the potential side effects?

Specific side effects are not listed, but since ONCObind involves extracorporeal blood purification, potential risks may include infection at the access site, bleeding, and reactions related to the filtration process.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 or older with specific pancreatic or colorectal cancer.

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I can do most of my daily activities on my own.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot undergo treatments that involve external machines due to unstable blood pressure.

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My high blood pressure is not controlled, even with treatment.

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I am currently dealing with a serious infection that isn't under control.

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I am on dialysis for kidney failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60, 120, 180 and 210 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60, 120, 180 and 210 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60, 120, 180 and 210 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

Capacity for the ONCObind filter to remove circulating tumor cells

Change in CTC Concentration

Evaluate the Quality of Life (QOL)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: ONCObind (Onco-Seraph) 100 Filter is a single useExperimental Treatment1 Intervention

The ONCObind 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. ONCObind 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.

Group II: Matched ControlsExperimental Treatment1 Intervention

Study patients will be assigned to receive procedure with the investigational device (ONCObind) and will be matched with 60 site specific controls, 30 PDAC and 30 CRC.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ONCObind (Onco-Seraph) 100 Filter

2024

N/A

~10

0 / 6Eligibility criteria met