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The impact of Thromboprophylaxis on Progression Free Survival of Patients with Advanced Pancreatic Cancer. The Pancreatic Cancer & Tinzaparin Prospective (imPaCT-PRO) study
EU CTIS ID: 2024-520043-17-00
What this study is testing
Evaluate the impact of VTE prevention on progression-free survival (PFS). Investigate the efficacy of long term VTE prevention with simultaneously administration of tinzaparin during 1st line chemotherapy in patients undergoing anticancer treatment with NabG for locally advanced or metastatic PC.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Locally Advanced or metastatic PC (confirmed by the recommended histological and imaging methods).
- Age ≥ 18 years.
- Planning to start 1st line chemotherapy with NabG.
- Eastern Cooperative Group (ECOG) 0-2.
- Life expectancy >6 months.
- Written informed consent.
You likely can't join if
- Subjects with contraindication to receive anticoagulant: a. Any hypersensitivity to anticoagulant or excipients. b. History of heparin-induced thrombocytopenia type II (HIT II). c. Active major bleeding or pre-diathesis for major bleeding d. Septic endocarditis.
- Creatinine clearance <20 mL/min according to Cockcroft-Gault formula.
- Platelet count < 50 G/L at inclusion.
- Hepatic dysfunction defined as at least one of the following: AST and/or ALT > 5 x ULN, bilirubin > 2 x ULN.
- Recent (< 1 month) oncological surgery, major abdominal or thoracic surgery, major orthopedic surgery, vascular surgery.
- Recent (< 1 month) acute coronary syndrome or any other arterial thrombosis, thrombotic or hemorrhagic stroke.
See the full eligibility criteria
- Locally Advanced or metastatic PC (confirmed by the recommended histological and imaging methods).
- Age ≥ 18 years.
- Planning to start 1st line chemotherapy with NabG.
- Eastern Cooperative Group (ECOG) 0-2.
- Life expectancy >6 months.
- Written informed consent.
- Subjects with contraindication to receive anticoagulant: a. Any hypersensitivity to anticoagulant or excipients. b. History of heparin-induced thrombocytopenia type II (HIT II). c. Active major bleeding or pre-diathesis for major bleeding d. Septic endocarditis.
- Creatinine clearance <20 mL/min according to Cockcroft-Gault formula.
- Platelet count < 50 G/L at inclusion.
- Hepatic dysfunction defined as at least one of the following: AST and/or ALT > 5 x ULN, bilirubin > 2 x ULN.
- Recent (< 1 month) oncological surgery, major abdominal or thoracic surgery, major orthopedic surgery, vascular surgery.
- Recent (< 1 month) acute coronary syndrome or any other arterial thrombosis, thrombotic or hemorrhagic stroke.
- Patients on chronic anticoagulation or on dual anti-platelet treatment.
- Pregnancy/lactation or insufficient contraception during the study and up to 3 months after the study.
- Severe concomitant disease that as per investigator's judgement is not compatible with participation in the study.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.