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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06001567
• Other study ID #: MIIR-12
• Status: Recruiting
• Phase: Phase 2
• Start date: August 14, 2023
• Est. completion date: August 13, 2024

Study information

• Verified date: August 2023
• Source: Second Affiliated Hospital of Guangzhou Medical University
• Contact: Mingyue Cai, Dr.
• Phone: +86-20-34156205
• Email: cai020[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 13, 2024
• Est. primary completion date: August 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Thrombocytopenia

Intervention

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.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

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