Hepatocellular Carcinoma, Thrombocytopenia
Conditions
Keywords
Thrombocytopenia, Hepatocellular Carcinoma, Transarterial Chemoembolization, hepatic arterial infusion chemotherapy
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.
Interventions
DRUGAvatrombopag
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.
Sponsors
Second Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactMingyue Cai, Dr.
Backup ContactKangshun Zhu, Dr.
Outcome results
None listed