Aprepitant Plus Granisetron and Dexamethasone for the Prevention of Vomiting in Patients With HAIC Therapy for HCC

NCT05711823 | Unknown Phase 3 DMC

• 1 other identifier: ARGUE
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the safety and efficacy of aprepitant combined with granisetron and dexamethasone versus granisetron and dexamethasone in the prevention of nausea and vomiting in patients with hepatocellular carcinoma (HCC) receiving hepatic arterial infusion chemotherapy (HAIC).

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  Complete response rate during the first cycle defined as no emetic episodes, no rescue medication use during the first cycle of HAIC therapy.

  3 weeks

Study Arms (2)

Aprepitant in combination with granisetron and dexamethasone

EXPERIMENTAL

Patients with unresectable hepatocellular carcinoma will receive aprepitant in combination with granisetron and dexamethasone during the therapeutic process of hepatic arterial infusion chemotherapy.

Drug: Aprepitant in combination with granisetron and dexamethasone

granisetron and dexamethasone

ACTIVE COMPARATOR

Patients with unresectable hepatocellular carcinoma will receive granisetron and dexamethasone during the therapeutic process of hepatic arterial infusion chemotherapy.

Drug: Granisetron and dexamethasone

Interventions

Aprepitant in combination with granisetron and dexamethasone DRUG

Patients with unresectable hepatocellular carcinoma will receive aprepitant in combination with granisetron and dexamethasone during the therapeutic process of hepatic arterial infusion chemotherapy.

Aprepitant in combination with granisetron and dexamethasone

Granisetron and dexamethasone DRUG

Patients with unresectable hepatocellular carcinoma will receive granisetron and dexamethasone during the therapeutic process of hepatic arterial infusion chemotherapy.

granisetron and dexamethasone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-75 years old;
• The patient is diagnosed with hepatocellular carcinoma according to the clinical diagnostic criteria of the Guideline for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) issued by the Health Commission of the People's Republic of China or confirmed by histopathology;
• ECOG performance score 0 or 1;
• Child-Pugh score of 5-7 (liver function);
• Receiving hepatic arterial infusion chemotherapy treatment;
• Expected survival time ≥6 months;
• Hematological indexes should meet the following conditions: hemoglobin ≥90 g/L; Absolute neutrophil count ≥1.5×10\^9/L; Platelet ≥75×10\^9/L; Total bilirubin ≤1.5×ULN; ALT≤3×ULN; AST≤3 x ULN; Alkaline phosphatase (AKP) ≤2.5×ULN; Serum albumin ≥28 g/L; Serum creatinine ≤1.5×ULN;
• Urine protein \<2+ or 24h urine protein quantity \< 1.0g;

You may not qualify if:

• Received systematic chemotherapy in the past;
• The presence of congenital or acquired immunodeficiency diseases (such as HIV positive);
• Active infection, or body temperature ≥ 38.5℃ or white blood cell count \> 15 x 10\^9/L 7 days before enrollment;
• Complications of arterial or venous thrombosis, such as cerebrovascular accident, deep vein thrombosis and pulmonary infarction, etc. within 6 months;
• Those who have a history of alcohol or psychotropic drug abuse and cannot quit or have mental disorders;
• Pregnant or lactating women;
• being treated with immunosuppressants or glucocorticoids (\>10mg prednisone equal dose per day) within 2 weeks;
• Previous history of motion sickness, or combined with hepatic encephalopathy or brain metastases;
• Uncontrolled heart disease or symptoms (including but not limited to grade II or above heart function, unstable angina, myocardial infarction in the past 1 year, supraventricular or ventricular arrhythmias requiring treatment or intervention)

Sponsors & Collaborators

• Guangxi Medical University: lead

Related Publications (2)

• Zhao Y, He M, Liang R, Li Q, Shi M. Evaluation of Antiemetic Therapy for Hepatic Arterial Infusion Chemotherapy with Oxaliplatin, Fluorouracil, and Leucovorin. Ther Clin Risk Manag. 2021 Jan 22;17:73-77. doi: 10.2147/TCRM.S283192. eCollection 2021.

  PMID: 33519205 BACKGROUND

• Roila F, Molassiotis A, Herrstedt J, Aapro M, Gralla RJ, Bruera E, Clark-Snow RA, Dupuis LL, Einhorn LH, Feyer P, Hesketh PJ, Jordan K, Olver I, Rapoport BL, Roscoe J, Ruhlmann CH, Walsh D, Warr D, van der Wetering M; participants of the MASCC/ESMO Consensus Conference Copenhagen 2015. 2016 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting and of nausea and vomiting in advanced cancer patients. Ann Oncol. 2016 Sep;27(suppl 5):v119-v133. doi: 10.1093/annonc/mdw270. No abstract available.

  PMID: 27664248 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Aprepitant; Granisetron; Dexamethasone

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Le-Qun Li

  Guangxi Medical University Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Jian-Hong Zhong, Ph.D

CONTACT

+86 771 5301253; zhongjianhong66@163.com

Liang Ma

CONTACT

+86 771 5301253; malianggxyd@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor do not know which patients received antiemetic therapy.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Aprepitant in combination with Granisetron and dexamethasone

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 3, 2023
• Study Start: July 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share