Status:
UNKNOWN
Avatrombopag for HCC Patients With Thrombocytopenia Who Intend to Undergo TACE and/or HAIC
Lead Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Conditions:
Thrombocytopenia
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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/o...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 13 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06001567
Start Date
August 14 2023
End Date
August 13 2024
Last Update
September 14 2023
Active Locations (1)
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1
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260