A Multicentre Real-world Study of Heptapopal Ethanolamine Tablets in Concurrent/Sequential Radioimmunoinduced Thrombocytopenia

N/ANot Yet RecruitingNCT06376435

Hebei Medical University Fourth Hospital500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Cancer, Therapy-Related

Interventions

Herombopag Olamine TabletsDRUG

Herombopag Olamine；combined rhTPO;combined IL-11

Eligibility

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The proportion of patients recovered to 100×109/L

The proportion of patients who recovered to 100×109/L within 14 days after starting treatment with the drug was studied

Time frame: 14 days after starting treatment with the study drug

Secondary Outcomes

The proportion of patients recovered to 75×109/L

The proportion of patients who recovered to 75×109/L after starting treatment with the drug was studied

Time frame: up to 2 months

Time for platelet recovery to 100×109/L

Study the time for platelet recovery to 100×109/L after drug initiation

Time frame: up to 2 months

Proportion of patients with treatment delay or dose reduction

Proportion of patients with delayed or reduced dose of radiotherapy, chemotherapy, immunosuppressants, etc

Time frame: up to 2 months

TRAE

Study drug-related adverse reactions

Time frame: up to 2 months