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A prospective and exploratory clinical study of Herombopag Olamine tablets in patients with malignant digestive tract tumors associated with tumor therapy-associated thrombocytopenia

A prospective and exploratory clinical study of Herombopag Olamine tablets in patients with malignant digestive tract tumors associated with tumor therapy-associated thrombocytopenia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058727
Enrollment
Unknown
Registered
2022-04-15
Start date
2022-06-01
Completion date
Unknown
Last updated
2024-01-14

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

Conditions

CTRT

Interventions

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The patient signed the informed consent form and voluntarily joined the study; 2. Age 18-75, male or female; 3. Patients with malignant gastrointestinal tumors confirmed by histopathology or cytology; 4. The subject is currently receiving a 21 day cancer treatment program (excluding other tumor treatment cycles), and needs to use one or more of the following chemotherapy drugs: 1) Gemcitabine 2) Platinum 3) Taxol 4) Fluorouracil: Fluorouracil, Capecitabine, Tegio 5. It can accept the current tumor treatment scheme for at least 3 cycles; 6. The investigator determined that the patient could receive the drug of Herteppa; 7. The subject had grade 2 or more thrombocytopenia in the last anti-tumor treatment cycle, which is defined as platelet count (PLT) = 75 × 109/L And the platelet value in this cycle recovers to = 100 × 109/L, resume anti-tumor treatment; 8. Life expectancy at screening = 12 weeks; 9. ECOG: 0-2 points; 10. The main organs function normally without serious complications.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breast-feeding women; 2. Inability to understand the nature of the research or to obtain informed consent; 3. Other conditions that the investigator determines are not suitable for inclusion in the study; 4. Thrombocytopenia caused by other causes other than thrombocytopenia caused by tumor treatment (such as chronic liver disease, sepsis, disseminated intravascular coagulation, immune thrombocytopenia, etc.); 5. Participants with blood history or tumor bone marrow infiltration; 6. Participants receiving synchronous radiotherapy; 7. Arterial or venous thrombosis events in the last 6 months; 8. There are infections that are difficult to control.

Design outcomes

Primary

MeasureTime frame
The response rate of Herombopag;

Secondary

MeasureTime frame
The lowest platelet value from the beginning of treatment to the end of treatment period;;The time of platelet < 50×109/L from the beginning of treatment to the end of treatment period;;At least one times platelet infusion rate or the proportion of rescue therapy prescribed by the protocol;;The changes of platelet values during the follow-up period;;Security;

Countries

China

Contacts

Public ContactHewei

The First Affiliated Hospital of Zhengzhou University

hewei726@126.com+86 18638553286

Outcome results

None listed

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