Cancer, Therapy-Related
Conditions
Brief summary
The objective of this study was to observe and evaluate the efficacy and safety of hexapopal ethanolamine tablets in the treatment of synchronous/sequential radioimmunoinduced thrombocytopenia in the real world. The subjects of this study were patients with solid malignant tumors who had received radioimmunoinduced thrombocytopenia. This study will retrospectively and prospectively collect real-world data related to investigational drugs, and will observe 500 patients to observe the diagnosis and treatment pattern of radiochemo-induced thrombocytopenia. The study included a screening period (no more than one week) and a treatment period (at least two cycles).Participants meeting protocol inclusion criteria were defined as having platelet values \< 100×109/L during radioimmunotherapy.
Interventions
Herombopag Olamine；combined rhTPO;combined IL-11
Sponsors
Hebei Medical University Fourth Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Understand the research procedure and voluntarily sign the informed consent to participate in the study * Subjects ≥18 years of age receiving synchronous/sequential chemotherapeutic therapy * Patients with platelet count ≤100×109/L or platelet count decrease ≥ 50×109/L or platelet count \> 100×109/L but need to be prophylaxis with hexapopethanolamine tablets * Researchers believe that subjects need to be treated with hexapopal.
Exclusion criteria
* The subjects are conducting clinical intervention studies * Patients with known or expected allergy or intolerance to the active ingredient or excipient of hexapopar * Pregnant or lactating women * Other conditions deemed unsuitable for inclusion in the study by the researcher.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients recovered to 100×109/L | 14 days after starting treatment with the study drug | The proportion of patients who recovered to 100×109/L within 14 days after starting treatment with the drug was studied |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients recovered to 75×109/L | up to 2 months | The proportion of patients who recovered to 75×109/L after starting treatment with the drug was studied |
| Time for platelet recovery to 100×109/L | up to 2 months | Study the time for platelet recovery to 100×109/L after drug initiation |
| Proportion of patients with treatment delay or dose reduction | up to 2 months | Proportion of patients with delayed or reduced dose of radiotherapy, chemotherapy, immunosuppressants, etc |
| TRAE | up to 2 months | Study drug-related adverse reactions |
Outcome results
None listed