NCT06001567

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

August 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2024

Completed
Last Updated

September 14, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

August 7, 2023

Last Update Submit

September 12, 2023

Conditions

ThrombocytopeniaHepatocellular Carcinoma

Keywords

ThrombocytopeniaHepatocellular CarcinomaTransarterial Chemoembolizationhepatic arterial infusion chemotherapy

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Secondary Outcomes (5)

  • Proportion of patients with PLT >75×10^9/L

    1 year

  • Proportion of patients with PLT doubling from baseline

    1 year

  • Increace in PLT

    1 year

  • Proportion of patients who successfully receive TACE/HAIC

    1 year

  • Adverse events (AEs)

    1 year

Study Arms (1)

Avatrombopag

EXPERIMENTAL

Patients receive avatrombopag treatment 5-10 days.

Drug: Avatrombopag

Interventions

AvatrombopagDRUG

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.

Avatrombopag

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

MeSH Terms

Conditions

ThrombocytopeniaCarcinoma, Hepatocellular

Interventions

avatrombopag

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopeniaAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Mingyue Cai, Dr.

CONTACT

+86-20-34156205cai020@yeah.net

Kangshun Zhu, Dr.

CONTACT

+86-20-34156205zhksh010@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2023

First Posted

August 21, 2023

Study Start

August 14, 2023

Primary Completion

August 13, 2024

Study Completion

August 13, 2024

Last Updated

September 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)