Actively Recruiting
Herombopag for Chemotherapy-induced Thrombocytopenia: a Prospective Multi-center One-arm Study in Solid Tumors
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-02-24
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
T
Tianjin Medical University Cancer Institute and Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Herombopag for treating chemotherapy-induced thrombocytopenia (CIT) in patients with solid tumors. This single-arm Phase 2 study includes patients who have previously been treated with recombinant human thrombopoietin (rhTPO) or interleukin 11 (IL-11) but did not reach effective platelet levels or lost response after retreatment. The study compares Herombopag's outcomes with historical or concurrent data from other treatments such as supportive care, Eltrombopag, or Avatrombopag. Participants will start Herombopag treatment at a dose of 7.5 mg daily, with weekly platelet count monitoring to guide dose adjustments. The maximum daily dose is 7.5 mg, and the dose may be lowered or stopped if platelet counts exceed certain thresholds for specific durations. If further chemotherapy or radiotherapy is not needed, tapering off Herombopag is allowed when platelet counts remain above 5010^9/L. The study will last up to 24 weeks with safety visits weekly for the first 4 weeks and continued monitoring. During the study, platelet counts will be tracked weekly to assess changes at 12 and 24 weeks after starting Herombopag. Researchers will also monitor adverse events and measure levels of thrombopoietin (TPO) and related antibodies in peripheral blood over 24 weeks. Safety visits occur weekly for the first month and if participants end or withdraw from the trial. The total duration of participation can be up to 24 weeks, with comparisons made to other treatments to understand Herombopag's safety and efficacy in chemotherapy-induced thrombocytopenia.
CONDITIONS
Brief Title
Herombopag for Chemotherapy-induced Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older, male or female
- Diagnosed with chemotherapy-induced thrombocytopenia (CIT)
- Ineffective response after repeated treatment with recombinant human thrombopoietin (rhTPO) or interleukin 11 (IL-11)
- Stopped radiotherapy or chemotherapy for more than 1 month
- Platelet counts below 30 x 10^9/L with bleeding tendency
- Estimated survival period of at least 6 months
- Willing to sign informed consent and follow the research program
- Liver and kidney function less than 1.5 times the upper limit of normal
- Using an acceptable method of contraception; women of childbearing potential must have a negative serum pregnancy test throughout the study
You will not qualify if you...
- Uncontrollable primary diseases of important organs (e.g., extensive metastasis, liver failure, heart failure, kidney failure)
- Poor compliance
- Positive for HIV, hepatitis B, hepatitis C, hepatitis D, syphilis, Epstein-Barr Virus DNA, or Cytomegalovirus DNA
- Severe bleeding such as hemoptysis, upper gastrointestinal bleeding, or intracranial hemorrhage
- Current heart disease requiring treatment or poorly controlled hypertension
- Thrombotic diseases like pulmonary embolism, thrombosis, or atherosclerosis
- Past allogeneic stem cell or organ transplantation
- Mental disorders preventing informed consent or trial participation
- Persistent toxic symptoms from prior treatments
- Other serious diseases restricting trial participation (e.g., diabetes, severe heart failure, unstable arrhythmia, gastric ulcers, autoimmune diseases)
- Sepsis or irregular bleeding
- Concurrent use of antiplatelet drugs
- Pregnant, suspected pregnancy, or breastfeeding
- Pre-existing cardiac disease including New York Heart Association Grade III/IV heart failure, arrhythmia requiring treatment, recent myocardial infarction, or QT abnormalities
- Investigator's judgment that participation is not appropriate for any other condition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive Herombopag daily with weekly platelet count monitoring and dose adjustments based on platelet levels.
Weekly visits for up to 24 weeks
Duration - 4 weeks
Participants complete weekly safety visits for 4 weeks after ending or withdrawing from treatment to monitor adverse events.
Weekly visits for 4 weeks
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
Y
Yunfei Chen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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