OSCAR II STUDY - The ONCObind CTC Removal Study

Korábbi kezelés

• 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).
• Participation in an investigational drug study or history of receiving any investigational treatment within 14 days prior to initiation of treatment on this study.
• Concurrent participation in any interventional clinical trial or has been previously entered in this trial.

Más betegség

• Patients with a history of heparin induced thrombocytopenia (HIT).
• Uncontrolled hypertension despite optimal management (systolic blood pressure >180mmHg
• Ongoing uncontrolled, serious infection.
• Renal failure requiring dialysis.

Laborértékek

• Patients with known allergy to heparin sodium.
• High risk of bleeding (platelet count <50mm3 or International Normalized Ratio (INR) >1.5)

Egyéb

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Pregnant or breast feeding
• Patients who cannot tolerate the placement of a tunneled catheter for vascular access to enable extracorporeal treatment.
• Patients with a life expectancy of less than 30 days.
• The Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator.
• Unable to obtain informed consent from either patient or legally authorized representative (LAR)
• Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.

• In order to be eligible to participate in this study, a patient must meet all of the following 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.
• 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.
• Patients must be of non-childbearing potential or using a medically acceptable contraceptive regimen. Effective contraception includes surgical sterilization (e.g., vasectomy, tubal ligation), two forms of barrier methods (e.g., condom, diaphragm) used with spermicide, IUDs.