Herombopag for the Prevention of Radio-chemotherapy Induced Thrombocytopenia in Cervical Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorPeking University Cancer Hospital & Institute

About this trial

Exploring and evaluating the efficacy of herombopag in preventing thrombocytopenia due to radiotherapy for cervical cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Volunteer to participate in the trial and sign the informed consent

Pathologically or cytologically confirmed cervical cancer

aged 18 years or older

ECOG performance score 0-1

Disqualifiers

Participants with other diseases of hematopoietic system, including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome

Participants with thrombocytopenia occurred within the last 6 months due to causes other than CTIT, including but not limited to chronic liver disease, hypersplenism, infection

Bone marrow invasion or metastasis

History of severe cardiovascular disease within the last 6 months, such as congestive heart failure (NYHA heart function score III-IV), arrhythmias known to increase the risk of thromboembolism such as atrial fibrillation, after coronary stenting, angioplasty, and para-coronary transplantation, etc

Trial design

Design model

Single group

Treatments tested in this trial

  • herombopag

    Drug

    receive harombopag for the prevention of thrombocytopenia in the next cycle of chemotherapy

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: HerombopagExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants with PLT <75×109/L after the use of herombopag

number of participants with PLT \<75×109/L/ all participants

Time frame
Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy

Secondary outcomes

1

minimum value of platelet after chemotherapy

minimum value of platelet of every participants after chemotherapy for every participants

Time frame
Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy
2

Change from baseline in PLT count minimum value

absolute value change from the maximum or minimum of platelet to baseline for every participants

Time frame
Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy
3

Median duration of PLT <75×109/L

the days during the PLT \<75×109/L of every participants

Time frame
Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy
4

Median time to recovery of PLT to ≥100×109/L

the days during the PLT \>100×109/L of every participants

Time frame
Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy

Other outcomes

Sponsors and contacts

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