NCT06001567

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Thrombocytopenia
• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Avatrombopag	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.

Timeline

• Start date: 2023-08-14
• Primary completion: 2024-08-13
• Completion: 2024-08-13
• First posted: 2023-08-21
• Last updated: 2023-09-14

Locations

1 site across 1 country: China