Avatrombopag for HCC Patients With Thrombocytopenia Who Intend to Undergo TACE and/or HAIC

Study Overview
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Brief Summary
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This study is conducted to evaluate the efficacy of avatrombopag for thrombocytopenia in patients with hepatocellular carcinoma (HCC) who intend to undergo transarterial chemoembolization (TACE) and/or hepatic arterial infusion chemotherapy (HAIC).

Detailed Description
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This is a single-center, prospective study to evaluate the efficacy of avatrombopag for thrombocytopenia in HCC patients who intend to undergo TACE and/or HAIC. 30 HCC patients with thrombocytopenia will be enrolled in this study. Avatrombopag (platelet count [PLT] <40×10^9/L, 60mg P.O. QD; PLT of 40-75×10^9/L, 40mg P.O. QD) will be administered to the patients and last 5-10 days. When the PLT reaches ≥100×10^9/L, the treatment will be discontinued. The primary end point of this study is the proportion of patients with PLT >75×10^9/L or doubling from baseline. The secondary endpoints are the proportion of patients with PLT >75×10^9/L, the proportion of patients with PLT doubling from baseline, the increace in PLT, the proportion of patients who successfully receive TACE/HAIC, .adverse events.

Official Title
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A Single-center, Single-arm Study of Avatrombopag for Patients With Hepatocellular Carcinoma and Thrombocytopenia Who Intend to Undergo Transarterial Chemoembolization and/or Hepatic Arterial Infusion Chemotherapy

Conditions
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Thrombocytopenia, Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Avatrombopag


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HCC with diagnosis confirmed pathologically or clinically Patients who need to receive TACE and/or HAIC, or have plans to undergo another treatment (3-6 weeks after the previous treatment) Child Pugh class A or B ECOG PS 0-2 PLT ≤ 75×10^9/L (10 days before interventional therapy) Exclusion Criteria: Thrombocytopenia caused by hematological diseases, non chemotherapy related thrombocytopenia (excluding liver cirrhosis with hypersplenism) PLT <30×10^9/L History of hepatic encephalopathy, refractory ascites, or hepatorenal syndrome History of arterial or venous thrombosis within 6 months Uncontrolled severe infections Pregnant or breastfeeding female patients Immune deficiencies, such as autoimmune diseases, HIV infected individuals, etc Anticoagulation or antiplatelet therapy witch cannot be suspended during the treatment period: heparin, warfarin, rivaroxaban, dipyridamole, non-steroidal anti-inflammatory drugs, aspirin, verapamil, Ticlopidine, clopidogrel, glycoprotein IIb/IIIa antagonists, erythropoietin, etc; Administration of blood products within 7 days prior to the baseline visit (excluding albumin infusion) Allergy to avatrombopag or any of its formulations History (such as gastrointestinal bleeding within 3 months, high risk of thrombosis, such as portal vein main flow velocity<10cm/s) which may affect the safety of the patients or their ability to complete the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avatrombopag<br>Patients receive avatrombopag treatment 5-10 days. | Drug: Avatrombopag<br>* Avatrombopag (platelet count [PLT] <40×10^9/L, 60mg P.O. QD; PLT of 40-75×10^9/L, 40mg P.O. QD) will be administered to the patients and last 5-10 days. When the PLT reaches ≥100×10^9/L, the treatment will be discontinued.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with PLT >75×10^9/L or doubling from baseline | The proportion of patients with PLT >75×10^9/L or doubling from baseline | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with PLT >75×10^9/L | The proportion of patients with PLT >75×10^9/L | 1 year | 
| Proportion of patients with PLT doubling from baseline | The proportion of patients with PLT doubling from baseline | 1 year | 
| Increace in PLT | the Increace in PLT after treatment | 1 year | 
| Proportion of patients who successfully receive TACE/HAIC | The proportion of patients who successfully receive TACE/HAIC | 1 year | 
| Adverse events (AEs) | Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thrombocytopenia, Hepatocellular Carcinoma, Transarterial Chemoembolization, hepatic arterial infusion chemotherapy