A Phase 2 interventional study of herombopag olamine tablets in Non-small Cell Lung Cancer, sponsored by Henan Cancer Hospital. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-02-23.
Sponsored by Henan Cancer Hospital · Phase 2, Interventional, and Treatment
The purpose of this study is to explore the safety and efficacy of herombopag olamine tablets for thrombocytopenia induced by chemotherapy combined with immunotherapy in non-small cell lung cancer
To observe and evaluate the safety and efficacy of the TPO receptor agonist herombopag for the secondary prevention of thrombocytopenia caused by chemotherapy combined with immunotherapy in non-small cell lung cancer.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Henan Cancer Hospital is the lead sponsor of 228 studies on the registry; 130 are open to participants now.
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Exclusion Criteria:
Drug: herombopag olamine tablets
The first day of chemotherapy was d1, and the drug was started from d-5, 5 days before chemotherapy, with oral herombopag 5 mg/day for a maximum of 14 days. After chemotherapy, when the thrombocytopenia rises to ≥200×109/L, drug discontinuation can be considered
Evaluate the response rate of hetrombopag
response if all of the following criteria are met: 1. No need for platelet transfusion 2. No need to reduce chemotherapy drug dose due to thrombocytopenia 3. No need to delay chemotherapy due to thrombocytopenia) Note: chemotherapy drug dose reduction It was defined as reducing the dose of the original chemotherapy drug by ≥20%, and chemotherapy delay was defined as delaying chemotherapy by \>7 days.
Time frame: Follow-up to 28 days after the last use of herombopag
The lowest platelet value after chemotherapy
The lowest platelet value after chemotherapy
Time frame: Follow-up to 28 days after the last use of herombopag
Platelet recovery to the highest value after chemotherapy;
Platelet recovery to the highest value after chemotherapy;
Time frame: Follow-up to 28 days after the last use of herombopag
The duration of platelets ≤50×109/L;
The duration of platelets ≤50×109/L;
Time frame: Follow-up to 28 days after the last use of herombopag
The time for platelets to recover to more than 100×109/L;
The time for platelets to recover to more than 100×109/L;
Time frame: Follow-up to 28 days after the last use of herombopag
Incidence of adverse events
Incidence of adverse events
Time frame: Follow-up to 28 days after the last use of herombopag
Changes of platelet value in each visit cycle
Changes of platelet value in each visit cycle
Time frame: Follow-up to 28 days after the last use of herombopag
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Henan Cancer Hospital