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).

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma; Thrombocytopenia
• Intervention / Treatment: Drug: Avatrombopag

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mingyue Cai, Dr.; Phone Number: +86-20-34156205; Email: cai020@yeah.net
• Study Contact Backup: Name: Kangshun Zhu, Dr.; Phone Number: +86-20-34156205; Email: zhksh010@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510260
      • Recruiting
      • The Second Affiliated Hospital of Guangzhou Medical University
      • Contact: Kangshun Zhu, Dr.; Phone Number: +86-20-34156205; Email: zhksh010@126.com
      • Principal Investigator: Kangshun Zhu, Dr.
      • Sub-Investigator: Mingyue Cai, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Avatrombopag; Patients receive avatrombopag treatment 5-10 days.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2023
• Primary Completion (Estimated): August 13, 2024
• Study Completion (Estimated): August 13, 2024

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma; hepatic arterial infusion chemotherapy; Thrombocytopenia; Transarterial Chemoembolization
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Hematologic Diseases; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Blood Platelet Disorders; Carcinoma; Carcinoma, Hepatocellular; Thrombocytopenia
• Other Study ID Numbers: MIIR-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No