To hear about similar clinical trials, please enter your email below
Trial Title:
Aprepitant Plus Granisetron and Dexamethasone for the Prevention of Vomiting in Patients With HAIC Therapy for HCC
NCT ID:
NCT05711823
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Vomiting
Dexamethasone
Dexamethasone acetate
Aprepitant
Granisetron
BB 1101
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Aprepitant in combination with Granisetron and dexamethasone
Primary purpose:
Prevention
Masking:
Single (Outcomes Assessor)
Masking description:
Outcome assessor do not know which patients received antiemetic therapy.
Intervention:
Intervention type:
Drug
Intervention name:
Aprepitant in combination with granisetron and dexamethasone
Description:
Patients with unresectable hepatocellular carcinoma will receive aprepitant in
combination with granisetron and dexamethasone during the therapeutic process of hepatic
arterial infusion chemotherapy.
Arm group label:
Aprepitant in combination with granisetron and dexamethasone
Intervention type:
Drug
Intervention name:
Granisetron and dexamethasone
Description:
Patients with unresectable hepatocellular carcinoma will receive granisetron and
dexamethasone during the therapeutic process of hepatic arterial infusion chemotherapy.
Arm group label:
granisetron and dexamethasone
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).
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.
Criteria for eligibility:
Criteria:
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:
- 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
July 1, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Guangxi Medical University
Agency class:
Other
Source:
Guangxi Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05711823
