Advanced Hepatocellular Carcinoma, Atezolizumab, Bevacizumab, Chemotherapy
Conditions
Keywords
hepatocellular carcinoma, Atezolizumab, Bevacizumab
Brief 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.
Interventions
PROCEDUREdTACE-HAIC
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
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 12 months | ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free-Survival (PFS) | 12 months | PFS is the length of time from the date of inclusion until tumor progression. |
| Overall survival (OS) | 24 months | OS is the length of time from the date of inclusion until death from any cause. |
Countries
China
Contacts
Primary ContactQunfang Zhou, MD
Backup ContactYe Liang, MD
Outcome results
None listed