About this trial
To evaluate the efficacy and safety of Romiplostim N01 to treat chemotherapy-induced thrombocytopenia in tumors
Eligibility criteria
Qualifiers
Age: 18 years or above, gender not restricted;
Patients who meet the diagnostic criteria for chemotherapy-related thrombocytopenia, and still ineffective after repeated treatment with rhTPO or IL-11 (subjects need to undergo regular rhTPO treatment for at least 14 days after radiotherapy and chemotherapy, with a dose of rhTPO 300u/kg/d or higher, and the platelet count remains less than 30×10^9/L, defined as refractory CTIT);
Patients who have stopped chemotherapy and radiotherapy for more than 1 month;
Patients with platelet count at enrollment < 30×10^9/L;
Disqualifiers
Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure, kidney failure and other diseases;
Patients with poor compliance;
Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and/or hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA;
Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, etc.
Trial design
Treatments tested in this trial
- Romiplostim N01
Treatment groups
Sponsors and collaborators
Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborator
Tianjin Medical University Second Hospital
Collaborator
Tianjin Third Central Hospital
Collaborator
Tianjin People's Hospital
Collaborator
Henan Cancer Hospital
Collaborator
The Second Affiliated Hospital of Kunming Medical University
Collaborator