The Impact of Thromboprophylaxis on Progression Free Survival of Patients With Advanced Pancreatic Cancer

NCT ID: NCT05178628

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2024-12-31

Brief Summary

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.

Detailed Description

Pancreatic cancer (PC) has the worst prognosis of any malignancy. Venous thromboembolism (VTE) occurs in 1:5 PC patients and is associated with significantly reduced progression-free survival (PFS). Phase III randomised controlled trials concluded that targeted thromboprophylaxis with low molecular weight heparins (LMWH) resulted in an 82% reduction in the relative risk of VTE without increasing major bleeding events, and that 11 patients were needed to be treated to prevent one VTE during chemotherapy. The benefits observed in the many of reported studies could not be accounted for by VTE prevention alone. Numerous experimental studies have demonstrated the antitumour, anti-metastatic and chemo-resistance reversal effect of LMWH.

The vast majority of the so far published evidence assessing the efficacy and safety of VTE prevention in ambulatory cancer patients is based on mixed patient populations with various types of cancers. Thus, current studies do not allow to estimate the real effect of long-term prophylaxis on clinical outcomes in selected homogeneous high-thrombotic risk patients.

An approach more specific to PC and restricted to advanced or metastatic patients is a modern and attractive strategy to assess the benefit of thromboprophylaxis in VTE prevention and beyond anticoagulation.

The objective of the imPaCT-PRO trial is to investigate the impact of thromboprophylaxis beyond anticoagulation in the improvement of the clinical outcomes in active PC patients receiving systemic anti-neoplasmatic treatment.

Conditions

Pancreatic Cancer; Thromboembolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Patients treated with Innohep® and chemotherapy

The patients in this arm will receive Innohep and chemotherapy with Gemcitabine + Nab-Paclitaxel (NabG) as per clinical practice.

Group Type: EXPERIMENTAL

Innohep

Intervention Type: DRUG

Patients will receive Tinzaparin sodium 20.000 Anti-Xa IU/ml in prefilled syringes. Administered at 175 Anti-Xa IU/Kgr of body weight, subcutaneously, once daily

Patients treated with chemotherapy

The patients in this arm will receive chemotherapy with Gemcitabine + Nab-Paclitaxel (NabG) as per clinical practice.

Group Type: ACTIVE_COMPARATOR

Chemotherapy: Gemcitabine + Nab-Paclitaxel

Intervention Type: DRUG

All patients will receive chemotherapy per clinical practice

Interventions

Innohep

Patients will receive Tinzaparin sodium 20.000 Anti-Xa IU/ml in prefilled syringes. Administered at 175 Anti-Xa IU/Kgr of body weight, subcutaneously, once daily

Intervention Type: DRUG

Chemotherapy: Gemcitabine + Nab-Paclitaxel

All patients will receive chemotherapy per clinical practice

Intervention Type: DRUG

Other Intervention Names

Tinzaparin sodium

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michalis Karamouzis

OTHER

Sponsor Role: lead

Responsible Party

Michalis Karamouzis

Prof. Michalis Karamouzis

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Institute of Molecular Medicine and Biomedical Research

Athens, Attica, Greece

Site Status: RECRUITING

Eygenideio Hospital, Oncology Department

Athens, Attica, Greece

Site Status: RECRUITING

Countries

Greece

Facility Contacts

Michalis Karamouzis, Prof

Role: primary

info@imibe.org

+30 213 0237967

Michael Karamouzis, Prof.

Role: primary

mkaramouz@med.uoa.gr

+302107208100

Other Identifiers

imPaCT-PRO-01

Identifier Type: -

Identifier Source: org_study_id