The impact of Thromboprophylaxis on Progression Free Survival of Patients with Advanced Pancreatic Cancer. The Pancreatic Cancer & Tinzaparin Prospective (imPaCT-PRO) study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 6
- 主要终点
- PFS of patients receiving thromboprophylaxis with tinzaparin, in comparison with the PFS of patients not receiving such prevention (primary endpoint).
研究概览
简要总结
•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.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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-
- •Life expectancy >6 months.
- •Written informed consent.
排除标准
- •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.
结局指标
主要结局
PFS of patients receiving thromboprophylaxis with tinzaparin, in comparison with the PFS of patients not receiving such prevention (primary endpoint).
PFS of patients receiving thromboprophylaxis with tinzaparin, in comparison with the PFS of patients not receiving such prevention (primary endpoint).
All objectively confirmed VTE events during the study per treatment arm including symptomatic distal deep vein thrombosis (DVT), symptomatic or incidental proximal DVT (including iliac and cava thrombosis), symptomatic or incidental pulmonary embolism (PE) or both DVT and PE (co-primary endpoint) or fatal PE or vein thrombosis of rare localisation (i.e., splanchnic vein or cerebral vein thrombosis).
All objectively confirmed VTE events during the study per treatment arm including symptomatic distal deep vein thrombosis (DVT), symptomatic or incidental proximal DVT (including iliac and cava thrombosis), symptomatic or incidental pulmonary embolism (PE) or both DVT and PE (co-primary endpoint) or fatal PE or vein thrombosis of rare localisation (i.e., splanchnic vein or cerebral vein thrombosis).
次要结局
- % of patients experiencing at least one major bleeding event, according to the International Society on Thrombosis and Haemostasis (ISTH) criteria during the study per treatment arm.
- % of patients experiencing any bleeding event, including major, clinically relevant non-major bleeding (CRNMB) and minor bleeding events during the study per treatment arm.
- Incidence of VTE events, per event type, during the study per treatment arm.
- ORR, defined as the percentage of patients with complete response (CR) or partial response (PR) based on RECIST criteria.
- Change from baseline in QoL at 4 months and 10 months per treatment arm.
- Overall Survival (OS) of patients receiving tinzaparin thromboprophylaxis compared to OS of patients not receiving such prophylaxis.
研究者
Michalis Karamouzis
Scientific
Institute Of Molecular Medicine And Biomedical Research