Clinical trial NCT06001567: Avatrombopag for HCC Patients With Thrombocytopenia Who Intend to Undergo TACE and/or HAIC
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Thrombocytopenia
Hepatocellular Carcinoma
Keywords: Thrombocytopenia
Hepatocellular Carcinoma
Transarterial Chemoembolization
hepatic arterial infusion chemotherapy
Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with PLT >75×10^9/L or doubling from baseline
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of patients with PLT >75×10^9/L
timeFrame: 1 year
measure: Proportion of patients with PLT doubling from baseline
timeFrame: 1 year
measure: Increace in PLT
timeFrame: 1 year
measure: Proportion of patients who successfully receive TACE/HAIC
timeFrame: 1 year
measure: Adverse events (AEs)
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References: