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Trial Title:
bTAE-HAIC Combined With Lenvatinib and Sintilimab for Infiltrative Hepatocellular Carcinoma
NCT ID:
NCT06070636
Condition:
Liver Diseases
Hepatocellular Carcinoma
Immunotherapy
Lenvatinib
Sintilimab
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Diseases
Lenvatinib
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:
bTAE-HAIC
Description:
bTAE procedure was a 2.8-F microcatheter was superselectively inserted into the tumor
feeding artery using the coaxial technique. Then blank microspheres were used according
to the tumor blood supply vessels (40-120um, 100-300um, 300-500um, 500-700um). 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.
Arm group label:
bTAE-HAIC combined with Lenvatinib and Sintilimab
Intervention type:
Drug
Intervention name:
Lenvatinib
Description:
12 mg (or 8 mg) once daily (QD) oral dosing.
Arm group label:
bTAE-HAIC combined with Lenvatinib and Sintilimab
Other name:
TKI inhibits
Intervention type:
Drug
Intervention name:
Sintilimab
Description:
200mg intravenously every 32 weeks
Arm group label:
bTAE-HAIC combined with Lenvatinib and Sintilimab
Other name:
programmed cell death protein-1 (PD-1) antibody
Summary:
This study intends to evaluate the efficacy and safety of blank- microsphere
transcatheter arterial embolization-hepatic arterial infusion chemotherapy of
oxaliplatin, 5-fluorouracil and leucovorin (bTAE-HAIC) plus Lenvatinib and Camrelizumab
for patients with infiltrative hepatocellular carcinoma.
Detailed description:
Blank-microsphere transcatheter arterial embolization (bTAE) and hepatic arterial
infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin are effective
and safe for hepatocellular carcinoma. Lenvatinib is non-inferior to sorafenib in overall
survival in untreated advanced hepatocellular carcinoma. Sintilimab, a programmed cell
death protein-1 (PD-1) inhibitor, is effective and safe in patients with unresectable
hepatocellular carcinoma. No study has evaluated bTAE-HAIC plus Lenvatinib and
Sintilimab. Thus, the investigators carried out this prospective, single-arm study to
find out it.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Diagnosis of infiltrative HCC.
2. Infiltrative HCC was characterized as follows: nonencapsulated arterial phase
hyperenhancement; tumor washout in the period of portal phase, and noncircular,
ill-defined margin
3. Age between 18 and 75 years;
4. The maximum tumor size ≥10 cm, and the total tumor size ≥15 cm;
5. Infiltrative HCC, with PVTT type I or type II or limited metastases (≤5).
6. Child-Pugh class A or B;
7. Eastern Cooperative Group performance status (ECOG) score of 0-2;
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. HCC with capsule;
2. Extrahepatic metastasis >5;
3. Obstructive PVTT involving the main portal vein.
4. Serious medical comorbidities.
5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or
hepatic encephalopathy
6. Known history of HIV
7. History of organ allograft
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:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Qunfang Zhou, MD
Phone:
86 19868000115
Email:
zhouqun988509@163.com
Start date:
May 20, 2024
Completion date:
June 30, 2025
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/NCT06070636
