Blood Purification Procedure for Pancreatic Cancer

Overseen By Drina Aldana

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ExThera Medical Corporation

Disqualifiers: Pregnancy, Heparin allergy, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 96

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new blood purification procedure to determine its safety and effectiveness for individuals with advanced forms of cancer, specifically metastatic pancreatic or colorectal cancer unresponsive to standard treatments. The treatment employs a device called ONCObind (Onco-Seraph 100 Filter) to filter the blood and reduce harmful substances. Participants may qualify if they have metastatic pancreatic or colorectal cancer resistant to chemotherapy and can provide blood samples for the study.

As an unphased trial, this study offers patients access to innovative treatment options not yet widely available.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should not be in another investigational drug study or have received investigational treatment within 14 days before starting this trial.

What prior data suggests that this blood purification procedure is safe for pancreatic cancer patients?

Research has shown that the ONCObind (Onco-Seraph) 100 Filter has been used in earlier studies without major safety concerns. In one study, five patients with pancreatic cancer underwent the ONCObind procedure, and no safety issues emerged. This suggests that the treatment is generally safe for people.

The ONCObind Filter is a single-use device that cleans the blood outside the body to reduce harmful substances. While early results are promising, further research is needed to fully understand its safety. Those considering this treatment should review these findings and consult their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for pancreatic cancer, which often involve chemotherapy or targeted therapies, the ONCObind 100 Filter offers a unique approach by acting as a blood purification device. Researchers are excited about this treatment because it employs an extracorporeal hemoperfusion method, using ultra-high molecular weight polyethylene beads with heparin to potentially remove harmful pathogens and cancer-related particles from the bloodstream. This innovative mechanism could offer a new way to manage pancreatic cancer, providing benefits that current treatments do not address, and possibly improving patient outcomes by directly targeting the blood.

What evidence suggests that this blood purification procedure is effective for pancreatic cancer?

Research has shown that the ONCObind (Onco-Seraph) 100 Filter, which participants in this trial may receive, may help stabilize advanced pancreatic cancer. In some patients, using this device to filter blood has prevented the cancer from worsening. Medical scans in studies have confirmed that the disease remained stable. The ONCObind Filter removes cancer cells from the blood, potentially slowing the cancer's progression. These early results suggest that this treatment could be useful for managing cancers that no longer respond to standard treatments. ^{2 3 6 7 8}

Who Is on the Research Team?

Lakhmir Chawla, M.D.

Principal Investigator

ExThera Medical

Are You a Good Fit for This Trial?

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).

Inclusion Criteria

Patient or legally authorized representative must be willing and able to provide a signed informed consent

Patients must have a CTC concentration of at least 5 cells/mL

Patients must be of non-childbearing potential or using a medically acceptable contraceptive regimen

Exclusion Criteria

Pregnant or breast feeding

Patients who cannot tolerate the placement of a tunneled catheter for vascular access

Patients with a history of heparin induced thrombocytopenia (HIT)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Phase

Participants undergo the ONCObind procedure up to 3-5 times in the first week, followed by 1-3 treatments through week 4

4 weeks

Up to 8 treatments over the first 28 days

Procedure Follow-up Phase

Participants receive follow-up visits weekly through day 28, then monthly through day 60

8 weeks

Weekly visits through day 28, monthly visits through day 60

Long-term Follow-up

Participants are monitored for safety and effectiveness, with survival follow-up assessed at 60, 120, 180, and 210 days

210 days

Survival follow-up at 60, 120, 180, and 210 days

What Are the Treatments Tested in This Trial?

Interventions

• ONCObind (Onco-Seraph) 100 Filter

Trial Overview 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.

How Is the Trial Designed?

Group I: ONCObind (Onco-Seraph) 100 Filter is a single use Experimental Treatment 1 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 Controls Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

ExThera Medical Corporation

Lead Sponsor

Trials

8

Recruited

540+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12285521/

Extracorporeal blood filtration leading to tumor growth ... Our patient demonstrated significant clinical improvement with scans demonstrating stable disease. Keywords: extracorporeal blood filtration, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06655142

OSCAR II STUDY - The ONCObind CTC Removal Study This study is a Prospective Single Arm, dual cohort Open Label Feasibility trial to evaluate the initial safety and signal of efficacy of a novel ...

3. npcf.us npcf.us/clinical-trials/oscar-i-study-the-oncobind-ctc-removal-study/

OSCAR I STUDY - The ONCObind CTC Removal Study This study is a Prospective Single Arm Open Label Feasibility trial to evaluate the initial safety and signal of efficacy of a novel extracorporeal blood ...

4. oncotarget.com oncotarget.com/news/pr/blood-filtration-stabilizes-advanced-pancreatic-cancer-a-case-report/

Blood Filtration Stabilizes Advanced Pancreatic Cancer This is the first documented case of stable disease and reduced symptoms following CTC filtration in advanced pancreatic cancer.

5. extheramedical.com extheramedical.com/oncobind/

ONCObind™ Extracorporeal Procedure for Metastatic Cancer The ONCObind Procedure Hemoperfusion Filter is designed for the adsorption of circulating tumor cells (CTCs) from blood.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06655142

OSCAR II STUDY - The ONCObind CTC Removal Study This study is a Prospective Single Arm, dual cohort Open Label Feasibility trial to evaluate the initial safety and signal of efficacy of a novel ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-07934

OSCAR I STUDY - The ONCObind CTC Removal Study - NCI This study is a Prospective Single Arm Open Label Feasibility trial to evaluate the initial safety and signal of efficacy of a novel extracorporeal blood ...

8. extheramedical.com extheramedical.com/exthera-announces-completion-of-phase-i-oscar-i-trial/

ExThera Announces Completion of Phase I OSCAR I Trial A total of five patients with PDAC have completed the ONCObind Procedure with no safety concerns or signals that have been observed. Data has ...