Using avatrombopag to treat low platelet counts in liver cancer patients before chemotherapy
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
This study is testing if a medication called avatrombopag can help increase low platelet counts in liver cancer patients before they start chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06001567 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of avatrombopag in increasing platelet counts in patients with hepatocellular carcinoma (HCC) who have thrombocytopenia and are scheduled to undergo transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC). The study is a single-center, prospective design involving 30 patients who will receive avatrombopag for 5-10 days, with treatment aimed at achieving a platelet count of at least 100×10^9/L. The primary endpoint is the proportion of patients achieving a platelet count greater than 75×10^9/L or doubling from baseline, while secondary endpoints include overall treatment success and monitoring of adverse events.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with hepatocellular carcinoma who have low platelet counts and are planning to undergo TACE or HAIC.
Not a fit: Patients with thrombocytopenia due to hematological diseases or those with severe liver dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve the safety and efficacy of chemotherapy for liver cancer patients by effectively managing low platelet counts.
How similar studies have performed: While this approach is novel in the context of HCC and thrombocytopenia, similar studies have shown promise in managing platelet counts in other cancer treatments.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Mingyue Cai, Dr.
- Email: cai020@yeah.net
- Phone: +86-20-34156205
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.