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

Sponsor

Second Affiliated Hospital of Guangzhou Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06001567

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Thrombocytopenia Hepatocellular Carcinoma	Drug: Avatrombopag	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 14, 2023

Anticipated Primary Completion Date :

Aug 13, 2024

Anticipated Study Completion Date :

Aug 13, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Proportion of patients with PLT >75×10^9/L or doubling from baseline [1 year]
The proportion of patients with PLT >75×10^9/L or doubling from baseline

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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