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

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

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).

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.

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