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Not yet recruitingNCT05711823Updated Jan 23, 2024

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

A Phase 3 interventional study of Aprepitant in combination with granisetron and dexamethasone and Granisetron and dexamethasone in Hepatocellular Carcinoma, sponsored by Guangxi Medical University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-23.

Sponsored by Guangxi Medical University · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

Read the detailed description

FOLFOX regimen include oxaliplatin and 5-Fu. Oxaliplatin has a moderate emetic potential and 5-Fu has a low emetic potential according to European guideline for the prevention of nausea and vomiting caused by chemotherapy and radiotherapy. The Guideline recommend that patients receiving moderately emetogenic chemotherapy receive a three-drug regimen of 5-HT3, dexamethasone, and NK1-RA (aprepitant, fosaprepitant, netupitant or rolapitant). However, HAIC treatment is not through peripheral or central venous infusion of chemotherapy drugs as in other cancers, but through hepatic artery infusion of chemotherapy drugs. Chemotherapy drugs are mainly concentrated in the liver and belong to local chemotherapy, rather than systemic chemotherapy through the venous system. Therefore, although the HAIC regimen includes oxaliplatin and 5-Fu, two chemotherapeutic drugs that may cause vomiting, the literature on whether three-drug regimen is also needed to prevent vomiting has been less publicly reported. In order to further determine whether three-drug regimen is necessary, this project intends to conduct a multi-center, randomized, controlled trial to evaluate the efficacy and safety of aprepitant combined with granisetron and dexamethasone versus granisetron and dexamethasone in preventing nausea and vomiting in HCC patients receiving HAIC treatment. The results of this project will provide a reference for improving the quality of life of HCC patients during HAIC treatment, the compliance of follow-up treatment and saving medical resources.

02

Conditions studied

  • Hepatocellular Carcinoma
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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;
  • For women of childbearing age, contraceptive measures (such as intrauterine devices, contraceptive tablets or condoms) are required during the clinical trial until 120 days after the end of the clinical trial; Women of childbearing age had negative serum or urine HCG test results within 7 days prior to study inclusion; Male patients with fertile partners should use effective contraception during the study period and for 120 days after the study ends.

Exclusion criteria

Exclusion Criteria:

  • 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)
04

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Aprepitant in combination with granisetron and dexamethasone

    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

  • Active comparator
    granisetron and dexamethasone

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

    Drug: Granisetron and dexamethasone

Interventions

  • DrugAprepitant in combination with granisetron and dexamethasone

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

  • DrugGranisetron and dexamethasone

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

05

What researchers measure

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.

    Time frame: 3 weeks

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 33519205 ↗
  • 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. PubMed 27664248 ↗

Individual participant data

Plan to share: No — Data available on request due to privacy/ethical restrictions.

08

Registry details

Key details

Study ID
NCT05711823
Lead sponsor
Guangxi Medical University
Responsible party
Jian-Hong Zhong (Principal Investigator, Guangxi Medical University) — Principal investigator
First posted
Feb 3, 2023
Start date
Jul 1, 2024 (estimated)
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jan 23, 2024

Study contacts

Jian-Hong Zhong, Ph.D
Contact
zhongjianhong66@163.com
+86 771 5301253
Liang Ma
Contact
malianggxyd@163.com
+86 771 5301253
Le-Qun Li
study chair · Guangxi Medical University Cancer Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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