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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorHebei Medical University Fourth Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Patients with solid malignancies undergoing radiotherapy/chemotherapy/immunosuppressant induced thrombocytopenia

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Herombopag Olamine Tablets

    Drug

    Herombopag Olamine;combined rhTPO;combined IL-11

Treatment groups

500 Participants
are divided into 3 treatment groups
Group A: Single drug group1 intervention
Group B: combined rhTPO group1 intervention
Group C: combined IL-11 group1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

TRAE

Study drug-related adverse reactions

Time frame
up to 2 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: