Herombopag Olamine in the Treatment of Thrombocytopenia After Chemotherapy

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of hetrombopag in the treatment of thrombocytopenia after chemotherapy in patients with digestive system malignant tumors

Official Title
-----------------
An Exploring Single Arm Study on the Efficacy and Safety of Herombopag Olamine in the Treatment of Thrombocytopenia After Chemotherapy in Malignant Tumors of the Digestive System

Conditions
-----------------
Malignant Tumors of the Digestive System, Trombocitopenia

Intervention / Treatment
-----------------
* Drug: Hetrombopag Olamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteer to participate in clinical research and sign informed consent; Age ≥18 years; Digestive system malignancy confirmed by histology or cytology; Having used oxaliplatin combined with fluorouracil for at least one cycle of 21-day chemotherapy regimen (CAPOX or SOX regimen), platelet index after chemotherapy: ≥25×109/L and ≤75×109/L; At least 10 days between TPO, IL-11 or platelet transfusion; ECOG 0 to 2 points; Expected survival time > 3 months; Sufficient organ function for subsequent chemotherapy; Women of reproductive age must be willing to use adequate contraception during the study of drug treatment. Exclusion Criteria: Thrombocytopenia caused by non-tumor chemotherapy drugs occurred within 6 months before screening, including but not limited to EDTA-dependent pseudothrombocytopenia, hypersplenism, infection, and bleeding; Have any hematological malignancies, including leukemia, myeloma, bone marrow proliferative diseases, lymphoma or bone marrow proliferative diseases; Clinically significant acute or active bleeding within the week prior to screening; Subject has medically known hereditary prethrombotic syndrome (e.g., factor V Leiden mutation, prothrombin G20210A mutation, or hereditary antithrombin III (ATIII) deficiency) The subject has a history of major cardiovascular disease (e.g., congestive heart failure (New York Heart Association Class 3/ cardiac function), known arrhythmias (e.g., atrial fibrillation) that increase the risk of thromboembolic events, coronary stenting, angioplasty, or coronary artery bypass grafting); Subjects had a history of arterial or venous thrombosis within 3 months before screening; Use of a vitamin K antagonist (including low molecular weight heparin, factor Xa inhibitor, or thrombin inhibitor) within 7 days prior to screening; The subject has a history of chronic platelet or hemorrhagic disorders, or thrombocytopenia from causes other than CIT (e.g., chronic liver disease or immune thrombocytopenic purpura); TPO, IL-11 or platelet infusion were used within 10 days before enrollment; Previous use of thrombopoietin receptor agonists (e.g., eltrobopag, romiestine, etc.) Those who cannot be treated with oral drugs; Allergic to hetrombopag or any excipient; Those whose organ function could not tolerate further antitumor therapy as assessed by the investigator; This product is not recommended for use or discontinuation of treatment in patients who meet any of the following criteria for liver function ALT and AST > 8 x ULN. ALT or AST>5×ULN for 2 weeks; ALT or AST>3xULN (total bilirubin >2xULN or INR>1.5); ALT or AST>3×ULN with progressive fatigue, nausea, vomiting, right upper abdominal pain or tenderness, fever, rash, and/or eosinophilia (>5%).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Observation group<br>Herombopag Olamine Tablets | Drug: Hetrombopag Olamine<br>* Hetrombopag Olamine 7.5mg orally, once a day, for 14 days. This product should be taken on an empty stomach, 2 hours after oral administration before eating, avoid taking it with meals.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days required for platelet recovery to ≥75×10^9/ L | Days required for platelet recovery to ≥75×10^9/ L | At the end of Cycle 1 (each cycle is 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The lowest platelet count | The lowest platelet count | At the end of Cycle 2 (each cycle is 28 days) | 
| Safety of treatment | Measure of time from study enrollment until progression. | 2 Cycle (each cycle is 28 days) |