Treatment of Avatrombopag for Thrombocytopenia in Patients Undergoing Selective Resection of Hepatocellular Carcinoma

NCT05087459 | Unknown

• 1 other identifier: SKX-2005
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatocellular carcinoma (HCC) is one of the most common malignant tumors in the world, accounting for the second leading cause of cancer death in China.Surgical treatment of hepatocellular carcinoma is the most important means for long-term survival of patients with hepatocellular carcinoma, including hepatectomy and liver transplantation.Chronic liver disease caused by hepatitis B infection is the main pathogenic factor of liver cancer in China. Meanwhile, nearly 80% of patients with hepatocellular carcinoma are complicated with cirrhosis, and the incidence of thrombocytopenia in patients with cirrhosis is reported to be as high as 78%.Many previous studies have found that thrombocytopenia is closely related to perioperative outcome of hepatocellular carcinoma.The purpose of this study was to evaluate the efficacy and safety of avatripopa in the treatment of thrombocytopenia in patients with primary hepatocellular carcinoma undergoing elective hepatectomy and its effect on perioperative outcome.

Conditions

Thrombocytopenia

Keywords

Avatrombopag; Primary hepatocellular carcinoma; elective hepatectomy

Outcome Measures

Primary Outcomes (2)

• Percentage of patients with a platelet count ≥75×10^9/L and an increase of platelet count more than 20% from baseline

  The Percentage of patients in the treatment group with platelet count ≥75×10\^9/L (the highest test value of of platelet count was taken on day 9-12 of treatment) and an increase of platelet count more than 20% from baseline before operation.

  on day 9-12 of treatment

• Comparison of total amount of postoperative drainage fluid between treatment group and control group

  Comparison of total amount of postoperative drainage fluid on day 1, 3 and 5 after surgery between treatment group and control group

  on day 1-5 after surgery

Secondary Outcomes (7)

• Comparison of intraoperative blood loss

  During surgery

• Proportion of patients receiving remedial treatment due to bleeding risk after surgery

  on day 0-30 after surgery

• Indwelling time of drainage tube

  on day 0-10 after surgery

• Red blood cell count and hemoglobin content of drainage fluid

  on day 1-5 after surgery

• Postoperative hospitalization time

  on 0-30 day after surgery

Study Arms (1)

patients with primary hepatocellular carcinoma undergoing elective hepatectomy

The baseline platelet count before enrollment was \< 75×10\^9/L and \> 30×10\^9/L.The primary clinical diagnosis of hepatocellular carcinoma was confirmed, and the CNLC stages were Ia and Ib.An elective hepatectomy, including laparotomy or laparoscopic hepatectomy, except hepatectomy combined with splenectomy or radiofrequency ablation.

Drug: Avatrombopag

Interventions

Avatrombopag DRUG

On the basis of conventional treatment, Avatrombopag was added, 30×10\^9/L \< platelet count \< 50×10\^9/L patients received Avatrombopag 60mg/d, 50×10\^9/L≤ platelet count \< 75×10\^9/L patients received Avatrombopag 40mg/d for 5 consecutive days, and waited for a period of time after drug withdrawal.Surgery is expected to take place on day 10-13 of the initial dose.

Also known as: Doptelet

patients with primary hepatocellular carcinoma undergoing elective hepatectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Elective hepatectomy with thrombocytopenia in adults with primary hepatocellular carcinoma

You may qualify if:

• Be able to understand this study and be willing to abide by all research procedures and sign informed consent voluntarily before screening;
• Male or female, at least 18 years old when signing informed consent;
• The initial clinical diagnosis of hepatocellular carcinoma was confirmed, and the CNLC stages were IA and IB;
• Before enrollment, baseline platelet count \< 75×10\^9/L and \> 30×10\^9/L;
• Elective hepatectomy is proposed, including laparotomy or laparoscopic hepatectomy, except hepatectomy combined with splenectomy or radiofrequency ablation;
• Child-pugh GRADE A;
• HBsAg and/or anti-HCV positive;
• Male patients who are infertile or who agree to use appropriate contraceptive methods from the beginning of screening until the completion of the post-treatment phase;
• Women who have not undergone menopause or surgical sterilization need to agree to use highly effective contraception from the beginning of screening until the completion of the post-treatment phase;
• According to the opinions of researchers, those who can meet the requirements of this study.

You may not qualify if:

• Any diseases below: Solid malignancies other than hepatocellular carcinoma, blood system tumor, aplastic anemia, myelodysplastic syndrome, myelofibrosis, congenital thrombocytopenia, drug-induced thrombocytopenia, immune thrombocytopenia, need treatment of systemic infection (except viral hepatitis);
• Always thrombosis or current or former state (such as cerebral infarction, myocardial infarction, angina pectoris, coronary artery carotid stenting and angioplasty, coronary artery bypass grafting, congestive heart failure, known to increase the risk of thromboembolic events of arrhythmias such as atrial fibrillation, pulmonary thromboembolism, deep vein thrombosis or diffuse intravascular coagulation syndrome).
• A known history of hereditary prethrombotic syndrome (e.g., clotting factor V Leiden mutation, prothrombin G20210A mutation, or hereditary antithrombin III (ATIII) deficiency);
• Transfusion of platelets or blood products containing platelets within 7 days prior to screening;
• Use erythropoietin within 7 days before screening;
• Rhil-11,rhTPO, TPO receptor agonists (such as Avatriprap, altrippal, or romistetine) or splenic embolization within 30 days prior to screening;
• Use of any of the following drugs or treatments within 90 days prior to screening: chemotherapy, interferon preparations, radiation;
• Patients requiring systemic chemotherapy, targeted therapy, immunotherapy, traditional Chinese herbal therapy or radiation therapy during the study period;
• At screening time, hemoglobin level ≤9.0g/dL or ≥18.0g/dL in male patients and \> 15.0g/dL in female patients, and hematocrit in male ≥0.54 and female ≥0.45;
• Bleeding score ≥2 at screening (according to the WHO Bleeding scale);
• Pt-inr and APTT at screening were lower than 80% of the lower limit of normal range or higher than 120% of the upper limit of normal range;
• Preoperative anticoagulant or antiplatelet therapy should not be suspended according to the standard (low-dose aspirin is allowed to continue);
• Female subjects who are breast-feeding or pregnant at the time of screening, or who plan to become pregnant during the study period;
• Known or suspected persistent alcohol or drug abuse;
• Known allergy to Avatripopa or any of its excipients;

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan hospital, Fudan University

Shanghai, China

RECRUITING

Related Publications (2)

• Miller JB, Figueroa EJ, Haug RM, Shah NL. Thrombocytopenia in Chronic Liver Disease and the Role of Thrombopoietin Agonists. Gastroenterol Hepatol (N Y). 2019 Jun;15(6):326-332.

  PMID: 31391802 BACKGROUND

• Li J, Han B, Li H, Deng H, Mendez-Sanchez N, Guo X, Qi X. Association of coagulopathy with the risk of bleeding after invasive procedures in liver cirrhosis. Saudi J Gastroenterol. 2018 Jul-Aug;24(4):220-227. doi: 10.4103/sjg.SJG_486_17.

  PMID: 29956689 BACKGROUND

MeSH Terms

Conditions

Thrombocytopenia; Carcinoma, Hepatocellular

Interventions

avatrombopag

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jian Zhou, MD PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Zhou, MD PhD

CONTACT

13801914007; zhou.jian@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 21, 2021
• Study Start: June 30, 2021
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)