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Single arm, prospective clinical study on the application of Haiqupopa ethanolamine tablets in the treatment of thrombocytopenia (CTIT) caused by tumor therapy

Single arm, prospective clinical study on the application of Haiqupopa ethanolamine tablets in the treatment of thrombocytopenia (CTIT) caused by tumor therapy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111291
Enrollment
Unknown
Registered
2025-10-29
Start date
2025-11-15
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Interventions

Test group:Hetrombopag

Sponsors

Henan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years old, regardless of gender; 2.Diagnosed as malignant solid tumor through histopathology or cytology; 3.Currently undergoing anti-tumor related treatments (such as chemotherapy, targeted therapy, immunotherapy, etc.), and at least holding Continue for more than one cycle; 4.Clearly confirmed thrombocytopenia caused by tumor treatment, with platelet count<75 × 10^9 /L; 5.Based on clinical judgment, it is necessary to continue receiving treatment with Hetrombopag; 6.ECOG PS score: 0-2 points; 7.Expected survival period is greater than 12 weeks; 8.The patient and/or legal representative fully understand the research method and voluntarily participate in this trial,And sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1. It has been confirmed that there is a history of severe allergies to the active ingredients and excipients of therapeutic drugs; 2. There are serious abnormalities in the main organ functions (such as liver and kidney function); 3.There are other underlying diseases and comorbidities that lead to thrombocytopenia, such as aplastic anemia, radiation sickness, immune thrombocytopenia, splenic hyperfunction, etc; 4. Having hereditary bleeding tendency, coagulation dysfunction, or high risk of bleeding, or having experienced thrombotic events (such as transient ischemic attack, cerebral hemorrhage, cerebral infarction, pulmonary embolism, etc.) within 6 months before the first use of medication; 5. Having uncontrolled hypertension (systolic blood pressure>160 mmHg and/or diastolic blood pressure>100 mmHg) and a history of hypertensive crisis or hypertensive encephalopathy; 6.Pregnant or lactating women; 7.There are multiple factors that affect the absorption of oral medication, such as inability to swallow, nausea and vomiting, chronic diarrhea, and intestinal obstruction; 8. History of severe mental disorders, drug abuse, alcohol or drug abuse, etc. in the past; 9. Currently participating in interventional clinical trials for treatment, or having received other investigational drugs or devices within 4 weeks prior to the first dose (failure screening in other clinical trials allows inclusion in this study); 10. According to the researchers' assessment, there are any other factors that may increase the research risk, affect patients' compliance with the protocol, or affect patients' completion of the trial, such as physiological or psychological disorders, that are not suitable for participating in this study;

Design outcomes

Primary

MeasureTime frame
Treatment response rate;

Secondary

MeasureTime frame
Adverse Events (AEs);Drug-related AEs;Abnormal laboratory test values;Incidence of serious adverse events (SAEs);Severity of Serious Adverse Events (SAEs);Incidence of treatment reduction or delay;Platelet count;

Countries

China

Contacts

Public ContactXinfeng Zhang

Henan Cancer Hospital

zhangxinfeng125@126.com+86 10 1234 5678

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026