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Trial Title:
dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Hepatocellular Carcinoma
NCT ID:
NCT06609863
Condition:
Advanced Hepatocellular Carcinoma
Atezolizumab
Bevacizumab
Chemotherapy
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
hepatocellular carcinoma
Atezolizumab
Bevacizumab
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
dTACE-HAIC
Description:
dTACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor
feeding artery using the coaxial technique. Then drug-eluting microspheres were used
(100-300um). The microcatheter was reserved at the proper/left/right hepatic artery
according tumor location. After the patient returned to the ward, the following
FOLFOX-based regime was intra-arterially administered through the microcatheter. The
FOLFOX regimen was administered via the hepatic artery as follows: 85 or 135 mg/m2
oxaliplatin from hour 0 to 2 on day 1, and 400 mg/m2 leucovorin from hour 2 to 4 on day
1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg/m2 fluorouracil
over 46 h on days 1 and 2. Hepatic arterial infusion chemotherapy administration of
oxaliplatin, fluorouracil, and leucovorin via the tumor feeding arteries every 4 weeks
Arm group label:
dTACE-HAIC plus Bevacizumab and Atezolizumab
Summary:
This study intends to evaluate the efficacy and safety of drug-eluting transcatheter
arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin,
5-fluorouracil and leucovorin (dTACE-HAIC) plus Bevacizumab and Atezolizumab for patients
with intermediate-advanced huge hepatocellular carcinoma.
Detailed description:
Drug-eluting transcatheter arterial embolization (dTACE) and hepatic arterial infusion
chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin are effective and safe
for hepatocellular carcinoma. Atezolizumab + Bevacizumab was superior to sorafenib in
overall survival in advanced hepatocellular carcinoma. The anti-VEGF combined programmed
cell death protein-1 legend 1 (PD-L1) inhibitor were effective and tolerable in patients
with advanced hepatocellular carcinoma. We aimed to describe the efficacy and safety of
locoregional therapy (dTACE/HAIC) combined with Bevacizumab and Atezolizumab inhibitor in
patients with huge hepatocellular carcinoma who can not receive radical therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Clinical diagnosis of HCC.
2. Age between 18 and 75 years;
3. The maximum tumor size ≥10 cm;
4. Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III
5. limited metastases (≤5).
6. Child-Pugh class A or B;
7. Eastern Cooperative Group performance status (ECOG) score of 0-1;
8. Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST
≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5
or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
9. Prothrombin time ≤18s or international normalized ratio < 1.7.
10. Ability to understand the protocol and to agree to and sign a written informed
consent document.
Exclusion Criteria:
1. Diffuse HCC;
2. Extrahepatic metastasis >5;
3. Obstructive PVTT involving mesenteric vena cava (PVTT IV).
4. Serious medical comorbidities.
5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or
hepatic encephalopathy
6. untreated or incompletely treated esophageal or gastric varices (assessed with
esophagogastroduodenoscopy) with bleeding or high risk of bleeding.
7. Eastern Cooperative Group performance status (ECOG) score of ≥2;
8. Known or suspected allergy to the investigational agents or any agent given in
association with this trial.
9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
10. Evidence of bleeding diathesis.
11. Patients with clinically significant gastrointestinal bleeding within 30 days prior
to study entry.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chinese PLA General hospital
Address:
City:
Beijing
Zip:
100853
Country:
China
Status:
Recruiting
Contact:
Last name:
Qunfang Zhou, MD
Email:
zhouqun988509@163.com
Contact backup:
Last name:
Feng Duan, MD
Phone:
8613910984586
Email:
duanfeng@vip.sina.com
Start date:
October 1, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06609863
