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

NCT ID: NCT06001567

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-14
• Study Completion Date: 2024-08-13

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.

Conditions

Thrombocytopenia; Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Avatrombopag

Patients receive avatrombopag treatment 5-10 days.

Group Type: EXPERIMENTAL

Avatrombopag

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Mingyue Cai, Dr.

Role: CONTACT

cai020@yeah.net

+86-20-34156205

Kangshun Zhu, Dr.

Role: CONTACT

zhksh010@163.com

+86-20-34156205

Facility Contacts

Kangshun Zhu, Dr.

Role: primary

zhksh010@126.com

+86-20-34156205

Other Identifiers

MIIR-12

Identifier Type: -

Identifier Source: org_study_id