Back to resultsbTAE-HAIC Combined With System Therapy for Intermediate-advanced Huge HCC
Primary Purpose
Liver Diseases, Hepatocellular Carcinoma, Immunotherapy
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
bTAE-HAIC
Lenvatinib
Camrelizumab
Sponsored by
About this trial
This is an interventional treatment trial for Liver Diseases
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of HCC. Age between 18 and 75 years; The maximum tumor size ≥10 cm, and the total tumor size ≥15 cm; Intermediate-advanced huge HCC, advanced HCC with PVTT type I or type II or limited metastases (≤5). Child-Pugh class A or B; Eastern Cooperative Group performance status (ECOG) score of 0-2; 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 Prothrombin time ≤18s or international normalized ratio < 1.7. Ability to understand the protocol and to agree to and sign a written informed consent document. Exclusion Criteria: Diffuse HCC; Extrahepatic metastasis >5; Obstructive PVTT involving the main portal vein. Serious medical comorbidities. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy Known history of HIV History of organ allograft Known or suspected allergy to the investigational agents or any agent given in association with this trial. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy Evidence of bleeding diathesis. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
Sites / Locations
- Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
bTAE-HAIC combined with Lenvatinib and Camrelizumab
Arm Description
bTAE procedure was a 2.8-F microcatheter was super-selectively 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). Hepatic arterial infusion of oxaliplatin, fluorouracil, and leucovorin every 4 weeks.
Outcomes
Primary Outcome Measures
Objective response rate (ORR)
ORR, as determined based on tumor response according to RECIST 1.1, is defined as
Secondary Outcome Measures
Progression free survival (PFS)
PFS is defined as the time from the date of inclusion to the date of the first objectively documented tumor progression or death due to any cause.
Full Information
NCT ID
NCT06061276
First Posted
September 24, 2023
Last Updated
October 6, 2023
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT06061276
Brief Title
bTAE-HAIC Combined With System Therapy for Intermediate-advanced Huge HCC
Official Title
Sequential bTAE-HAIC Combined With Lenvatinib and Camrelizumab for Intermediate-advanced Huge Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 intermediate-advanced huge 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. Camrelizumab, a programmed cell death protein-1 (PD-1) inhibitor, is effective and tolerable in patients with unresectable hepatocellular carcinoma. No study has evaluated bTAE-HAIC plus Lenvatinib and Camrelizumab. Thus, the investigators carried out this prospective, single-arm study to find out it.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases, Hepatocellular Carcinoma, Immunotherapy, Camrelizumab, Lenvatinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bTAE-HAIC combined with Lenvatinib and Camrelizumab
Arm Type
Experimental
Arm Description
bTAE procedure was a 2.8-F microcatheter was super-selectively 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). Hepatic arterial infusion of oxaliplatin, fluorouracil, and leucovorin every 4 weeks.
Intervention Type
Procedure
Intervention Name(s)
bTAE-HAIC
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Other Intervention Name(s)
TKI inhibits
Intervention Description
12 mg (or 8 mg) once daily (QD) oral dosing.
Intervention Type
Drug
Intervention Name(s)
Camrelizumab
Other Intervention Name(s)
programmed cell death protein-1 (PD-1) antibody
Intervention Description
200mg intravenously every 2 weeks
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
ORR, as determined based on tumor response according to RECIST 1.1, is defined as
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
PFS is defined as the time from the date of inclusion to the date of the first objectively documented tumor progression or death due to any cause.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Overall survival (OS)
Description
OS is the length of time from the date of inclusion until death from any cause.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of HCC.
Age between 18 and 75 years;
The maximum tumor size ≥10 cm, and the total tumor size ≥15 cm;
Intermediate-advanced huge HCC, advanced HCC with PVTT type I or type II or limited metastases (≤5).
Child-Pugh class A or B;
Eastern Cooperative Group performance status (ECOG) score of 0-2;
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
Prothrombin time ≤18s or international normalized ratio < 1.7.
Ability to understand the protocol and to agree to and sign a written informed consent document.
Exclusion Criteria:
Diffuse HCC;
Extrahepatic metastasis >5;
Obstructive PVTT involving the main portal vein.
Serious medical comorbidities.
Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
Known history of HIV
History of organ allograft
Known or suspected allergy to the investigational agents or any agent given in association with this trial.
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Evidence of bleeding diathesis.
Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qunfnag Zhou, MD
Phone
86 19868000115
Email
zhouqun988509@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhimei Hunag, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jinhua Huang, Profession
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
bTAE-HAIC Combined With System Therapy for Intermediate-advanced Huge HCC
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