Avatrombopag for HCC Patients With Thrombocytopenia Who Intend to Undergo TACE and/or HAIC
- Registration Number
- NCT06001567
- Lead Sponsor
- Second Affiliated Hospital of Guangzhou Medical University
- 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).
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Avatrombopag Avatrombopag Patients receive avatrombopag treatment 5-10 days.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Proportion of patients with PLT >75×10^9/L 1 year The proportion of patients with PLT \>75×10\^9/L
Adverse events (AEs) 1 year Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0.
Trial Locations
- Locations (1)
The Second Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China