Chemotherapy-induced thrombocytopenia in patients with adenocarcinoma of the gastrointestinal tract
Conditions
Interventions
test group:Patients with gastrointestinal adenocarcinoma who developed grade =2 thrombocytopenia (i.e., platelet count <75 × 109/L) during the previous chemotherapy cycle were selected, and after eval
Sponsors
The First Hospital of Shanxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. signed written informed consent prior to enrollment; 2. aged 18-75 years old; 3. adult patients with histologically or cytologically confirmed adenocarcinoma of the gastrointestinal tract, including esophageal, gastric and colorectal cancers. 4. chemotherapy regimens that include at least one platinum-based agent such as oxaliplatin. 5. all patients have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 6. have a life expectancy at screening of more than 12 weeks and are able to receive at least two additional cycles of their current chemotherapy regimen 7. a platelet value of 75 x 10^9/L and <300 x 10^9/L prior to the start of the platelet count in the second chemotherapy cycle 8. Subjects of childbearing potential who agree to use reliable contraception throughout the study.
Exclusion criteria
Exclusion criteria: Patients with any of the following are not eligible for enrollment in this study: 1. any hematologic disorder other than CIT (e.g., leukemia, primary ITP, myeloproliferative neoplasms, multiple myeloma, and myelodysplastic syndromes) 2. pelvic and spinal radiation therapy and bone field irradiation within 3 months prior to screening 3. thrombocytopenia due to causes other than CIT (e.g., chronic liver disease, splenomegaly, infection, bleeding) 4. history of severe cardiovascular disease (e.g., class III/IV congestive heart failure, arrhythmia or angina that increases the risk of thromboembolic events, unstable angina, coronary stenting, angioplasty, or coronary artery bypass graft) 5. arterial or venous thrombosis within 6 months; severe bleeding within 2 weeks prior to the screening visit Previous diagnosis of arterial thrombosis (e.g., cerebral thrombosis, transient ischemic attack, or myocardial infarction), or venous thrombosis (e.g., deep vein thrombosis, pulmonary embolism) 6. history of prior or concurrent medical conditions, or use of anticoagulant or antiplatelet medications at the time of screening; 7. a history of severe cardiovascular disease 8. is pregnant or breastfeeding, or has a pregnancy planned 9. be of childbearing potential and, in the judgment of the investigator, not adequately using contraception 10. have a history of severe allergic reactions to medications or hypersensitivity to the components of roprostin; 11. inability to comply for psychiatric reasons 12. is, in the judgment of the investigator, unsuitable for participation in this trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of receiving roprostin N01 for secondary prevention; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of chemotherapy delay;Incidence of bleeding events;Incidence of VTE; | — |
Countries
China
Contacts
Public ContactYusheng Wang
The First Hospital of Shanxi Medical University
Outcome results
None listed