Rivaroxaban Versus Low-molecular-weight Heparin for Preventing Thrombosis in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The study is designed to compare the efficacy and safety of oral rivaroxaban and subcutaneous low-molecular-weight heparin in preventing femoral venepuncture associated thrombosis among cancer patients.

Official Title
-----------------
Rivaroxaban Versus Low-molecular-weight Heparin in Preventing Thrombosis Among Cancer Patients After Femoral Venepuncture

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: Rivaroxaban 10 MG
* Drug: Rivaroxaban 20 MG
* Drug: Low-molecular-weight heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 85 Histologically or cytologically confirmed advanced or metastatic solid tumors Patients will be received femoral venepuncture for apheresis by cell separator, which is the necessary process to perform following adoptive cell immunotherapy. Estimated life expectancy > 3 months Adequate hematologic function, with WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL (it is acceptable to have had prior transfusion), platelets ≥ 75,000/microliter; PT-INR <1.5 (unless patient is receiving warfarin in which case PT-INR must be <3), PTT <1.5X ULN Adequate renal and hepatic function, with serum creatinine < 1.5 mg/dL, bilirubin < 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL), ALT and AST ≤ 2.5 x upper limit of normal. Exclusion Criteria: known conditions associated with high risk of bleeding, known history of hemorrhagic diathesis Platelet count < 50 000 G/L Active bleeding Patients with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Autoimmune related thyroid disease and vitiligo are permitted. Patients with obstructive jaundice Patients with Spleen hyperfunction Presence of an active acute or chronic infection including: a urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot). Patients with HIV are excluded based on immuno-suppression, which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections. Pregnant or breast-feeding women，or lack of effective contraceptive treatment for women of childbearing age.;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rivaroxaban 10mg daily<br>orally, 10 mg once daily for day1 and day 2 after femoral venepuncture | Drug: Rivaroxaban 10 MG<br>* Rivaroxaban pill 10mg qd, day1 and day2 after femoral venepuncture<br>|
| Experimental: Rivaroxaban 20mg daily<br>orally, 10 mg twice daily for day1 and day 2 after femoral venepuncture | Drug: Rivaroxaban 20 MG<br>* Rivaroxaban pill 10mg bid, day1 and day2 after femoral venepuncture<br>|
| Active Comparator: Low-molecular-weight heparin<br>subcutaneously, 0.4 ml once daily, before femoral venepuncture (day1) and after the day of femoral venepuncture (day 2) | Drug: Low-molecular-weight heparin<br>* 0.4 ml once daily, before femoral venepuncture(day1) and the following day (day 2)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of deep venous thrombosis | the incidence of deep venous thrombosis of the legs by the systematic examinations performed at the end of the 4-week after femoral venepuncture | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of participants with treatment-related adverse events as assessed by CTCAE v 3.0 | 4 weeks |