Clinical trial · Interventional
The Impact of Thromboprophylaxis on Progression Free Survival of Patients With Advanced Pancreatic Cancer
The Impact of Thromboprophylaxis on Progression Free Survival of Patients With Advanced Pancreatic Cancer: The Pancreatic Cancer & Tinzaparin Prospective (imPaCT-PRO) Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, randomized, multicenter, open-label, blinded-endpoint Phase III clinical trial to investigate the impact of thromboprophylaxis using innohep, beyond anticoagulation in the improvement of the clinical outcomes in active pancreatic cancer patients receiving systemic anti-neoplasmatic treatment. The number of patients that will be enrolled is 450. The enrollment period is 24 months and the follow up period is 10 months.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy: Gemcitabine + Nab-Paclitaxel | Drug | — | UNRESOLVED |
| Innohep | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patients treated with Innohep® and chemotherapy
- description
- The patients in this arm will receive Innohep and chemotherapy with Gemcitabine + Nab-Paclitaxel (NabG) as per clinical practice.
- interventionNames
- Drug: Innohep
- type
- ACTIVE_COMPARATOR
- label
- Patients treated with chemotherapy
- description
- The patients in this arm will receive chemotherapy with Gemcitabine + Nab-Paclitaxel (NabG) as per clinical practice.
- interventionNames
- Drug: Chemotherapy: Gemcitabine + Nab-Paclitaxel
Primary outcomes (2)
- measure
- PFS of patients
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Advanced or metastatic PC (confirmed by the recommended histological and imaging methods). 2. Age ≥ 18 years. 3. Planning to start 1st line chemotherapy with NabG. 4. Eastern Cooperative Group (ECOG) 0-2. 5. Life expectancy \>6 months. 6. Written informed consent. Exclusion Criteria: 1. Subjects with contraindication to receive anticoagulant: 1. Any hypersensitivity to anticoagulant or excipients. 2. History of heparin-induced thrombocytopenia type II (HIT II). 3. Active major bleeding or pre-diathesis for major bleeding 4. Septic endocarditis. 2. Creatinine clearance \<20 mL/min according to Cockcroft-Gault formula. 3. Platelet count \< 50 G/L at inclusion. 4. Hepatic dysfunction defined as at least one of the following: AST and/or ALT \> 5 x ULN, bilirubin \> 2 x ULN. 5. Recent (\< 1 month) oncological surgery, major abdominal or thoracic surgery, major orthopedic surgery, vascular surgery. 6. Recent (\< 1 month) acute coronary syndrome or any other arterial thrombosis, thrombotic or hemorrhagic stroke. 7. Patients on chronic anticoagulation or on dual anti-platelet treatment. 8. Pregnancy/lactation or insufficient contraception during the study and up to 3 months after the study. 9. Severe concomitant disease that as per investigator's judgement is not compatible with participation in the study.
References
Publications (0)
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