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

Second Affiliated Hospital of Guangzhou Medical University

Status and phase

Enrolling

Phase 2

Conditions

Thrombocytopenia

Hepatocellular Carcinoma

Treatments

Drug: Avatrombopag

Study type

Interventional

Funder types

Other

Identifiers

NCT06001567

MIIR-12

Details and patient eligibility

About

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).

Full description

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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