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

Primary Purpose

Thrombocytopenia, Hepatocellular Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Avatrombopag
Sponsored by
Second Affiliated Hospital of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombocytopenia focused on measuring Thrombocytopenia, Hepatocellular Carcinoma, Transarterial Chemoembolization, hepatic arterial infusion chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Avatrombopag

Arm Description

Patients receive avatrombopag treatment 5-10 days.

Outcomes

Primary Outcome Measures

Proportion of patients with PLT >75×10^9/L or doubling from baseline
The proportion of patients with PLT >75×10^9/L or doubling from baseline

Secondary Outcome Measures

Proportion of patients with PLT >75×10^9/L
The proportion of patients with PLT >75×10^9/L
Proportion of patients with PLT doubling from baseline
The proportion of patients with PLT doubling from baseline
Increace in PLT
the Increace in PLT after treatment
Proportion of patients who successfully receive TACE/HAIC
The proportion of patients who successfully receive TACE/HAIC
Adverse events (AEs)
Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0.

Full Information

First Posted
August 7, 2023
Last Updated
September 12, 2023
Sponsor
Second Affiliated Hospital of Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT06001567
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 14, 2023 (Actual)
Primary Completion Date
August 13, 2024 (Anticipated)
Study Completion Date
August 13, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombocytopenia, Hepatocellular Carcinoma
Keywords
Thrombocytopenia, Hepatocellular Carcinoma, Transarterial Chemoembolization, hepatic arterial infusion chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Avatrombopag
Arm Type
Experimental
Arm Description
Patients receive avatrombopag treatment 5-10 days.
Intervention Type
Drug
Intervention Name(s)
Avatrombopag
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients with PLT >75×10^9/L or doubling from baseline
Description
The proportion of patients with PLT >75×10^9/L or doubling from baseline
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Proportion of patients with PLT >75×10^9/L
Description
The proportion of patients with PLT >75×10^9/L
Time Frame
1 year
Title
Proportion of patients with PLT doubling from baseline
Description
The proportion of patients with PLT doubling from baseline
Time Frame
1 year
Title
Increace in PLT
Description
the Increace in PLT after treatment
Time Frame
1 year
Title
Proportion of patients who successfully receive TACE/HAIC
Description
The proportion of patients who successfully receive TACE/HAIC
Time Frame
1 year
Title
Adverse events (AEs)
Description
Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingyue Cai, Dr.
Phone
+86-20-34156205
Email
cai020@yeah.net
First Name & Middle Initial & Last Name or Official Title & Degree
Kangshun Zhu, Dr.
Phone
+86-20-34156205
Email
zhksh010@163.com
Facility Information:
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kangshun Zhu, Dr.
Phone
+86-20-34156205
Email
zhksh010@126.com
First Name & Middle Initial & Last Name & Degree
Kangshun Zhu, Dr.
First Name & Middle Initial & Last Name & Degree
Mingyue Cai, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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