OSCAR II STUDY - The ONCObind CTC Removal Study (NCT06655142) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
OSCAR II STUDY - The ONCObind CTC Removal Study
120 participantsStarted 2027-01-15
Plain-language summary
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 extracorporeal blood purification (EBP) procedure in either mPDAC or mCRC refractory to systemic therapy. Site selection will be dependent upon the site's familiarity with extracorporeal blood purification platforms as well as the diagnosis and management of mPDAC and mCRC. Adults (18 years old and older, ECOG PS of equal or less than 2) with a diagnosis of either mPDAC as defined histologically (microscopically) as a "pancreatobiliary type" adenocarcinoma who experienced disease progression or not tolerating fluoropyrimidine-, oxaliplatin- and irinotecan- based regimens or prior treatment with gemcitabine and nab-paclitaxel or are not candidates for chemotherapy or mCRC patients who experienced disease progression on 5-fluorouracil (5-FU), capecitabine, oxaliplatin and irinotecan as FOLFIRI and/or FOLFOX and/or XELOX and/or XELIR and/or FOLFOXIRI/FOLFIRINOX or who are not candidates for chemotherapy with at least 5 cells/mL CTCs in peripheral blood and/or portal vein.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients ≥ 18 years of age with
. mPDAC cohort: Metastatic pancreatic ductal cancer who experienced disease progression or not tolerating fluoropyrimidine-, oxaliplatin- and irinotecan- based regimens or prior treatment with gemcitabine and nab-paclitaxel or are not a candidate for chemotherapy
. mCRC Cohort : Metastatic CRC who experienced disease progression on 5-fluorouracil (5-FU), capecitabine, oxaliplatin and irinotecan as FOLFIRI and/or FOLFOX and/or XELOX and/or XELIRI and/or FOLFOXIRI/FOLFIRINOX or who are not candidates for chemotherapy.
. Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) scores of 2 or less.
. Patient or legally authorized representative is willing and able to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of procedure-emergent adverse events (AEs) graded using the NCI CTCAE Version 5.0
Timeframe: 210 days
2
Incidence of procedure-emergent serious adverse events (SAEs) graded using the NCI CTCAE Version 5.0
Timeframe: 210 days
3
Evaluation of Survival
Timeframe: 60, 120, 180 and 210 days
4
Change in CTC Concentration
Timeframe: 180 days
5
Capacity for the ONCObind filter to remove circulating tumor cells
. Patients with a CTC concentration of at least 5 cells/mL
. Must be willing to provide blood samples for prospective tumor molecular profiling and exploratory analyses.
. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
Exclusion criteria
. Pregnant or breast feeding
. Patients who cannot tolerate the placement of a tunneled catheter for vascular access to enable extracorporeal treatment.
. Patients with a history of heparin induced thrombocytopenia (HIT).
. Patients with known allergy to heparin sodium.
. High risk of bleeding (platelet count \<50mm3 or International Normalized Ratio (INR) \>1.5)
. Hemodynamic instability and inability to tolerate extracorporeal therapy (defined as MAP\<65 despite fluids and vasopressors and or sustained hypotension at enrollment as defined by two readings with systolic blood pressure (SBP) measurements below 100 mmHg or diastolic blood pressure (DBP) measurements below 50 mmHg. The measurements must be performed thirty minutes from one another, and the Subject must be resting for at least 5 minutes prior to obtaining each measurement. (If the first reading includes a SBP greater than 100 mmHg and a DBP greater than 50 mmHg, the second reading does not need to be taken).