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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-20

Study Completion Date

2026-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer, Therapy-Related

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single drug group

Herombopag Olamine Tablets

Intervention Type DRUG

Herombopag Olamine；combined rhTPO;combined IL-11

combined rhTPO group

Herombopag Olamine Tablets

Intervention Type DRUG

Herombopag Olamine；combined rhTPO;combined IL-11

combined IL-11 group

Herombopag Olamine Tablets

Intervention Type DRUG

Herombopag Olamine；combined rhTPO;combined IL-11

Interventions

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Herombopag Olamine Tablets

Herombopag Olamine；combined rhTPO;combined IL-11

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No