Back to resultsDEB-TACE vs. cTACE as Conversion Therapy for Unresectable Large HCC
Primary Purpose
Hepatocellular Carcinoma Non-resectable
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Drug-eluting bead transarterial chemoembolization (DEB-TACE)
Conventional transarterial chemoembolization (cTACE)
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma Non-resectable focused on measuring Hepatocellular carcinoma, Transarterial chemoembolization, Conversion therapy
Eligibility Criteria
Inclusion Criteria:
- Hepatocellular carcinoma confirmed by histopathology and/or cytology, or diagnosed clinically.
- The tumor lesion was only localized in one liver lobe.
- Large HCC with single lesion > 7 cm, or multiple lesions.
- unresectable HCC evaluated by the surgeon team.
- The patient is suitable for TACE treatment, which is evaluated by MDT.
- At least one measurable intrahepatic target lesion.
- Patients without cirrhosis, or with cirrhosis but the liver function of Child-Pugh Class A.
- ECOG score of performance status ≤ 1 point.
- Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×109/L, absolute value of neutrophils >1.5×109/L, hemoglobin ≥85 g/L, total bilirubin ≤30 μmol/L, albumin ≥35 g/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR<1.5 or PT/APTT normal range.
- Patients have the willingness to receive TACE as the conversion therapy for surgical resection.
Exclusion Criteria:
- Accompanied with tumor thrombus involving the main portal vein, first-order branch or bilateral branches of portal vein.
- Accompanied with hepatic vein and vena cava tumor thrombus.
- The extent of the lesion exceeds one liver lobe or extrahepatic metastasis.
- Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.
- Those with organs (heart and kidneys) dysfunction who cannot tolerate TACE treatment and surgical hepatectomy.
- History of other malignancies.
- Uncontrollable infection.
- Patients with active hepatitis B must undergo antiviral therapy to control HBV-DNA <10^3 IU/mL.
- HCV patients need to complete the anti-HCV therapy before they are enrolled.
- History of HIV.
- Allergic to the drugs involved in the research.
- Patients with gastrointestinal bleeding within 30 days, or other bleeding> CTCAE grade 3.
- History of organ or cells transplantation. Previous treatment with TACE, intra-arterial infusion chemotherapy, radiotherapy, or systemic therapy
- Those with bleeding tendency.
Sites / Locations
- the Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DEB-TACE
cTACE
Arm Description
DEB-TACE will be performed for the patients who choose DEB-TACE as the primary treatment.
cTACE will be performed for the patients who choose cTACE as the primary treatment.
Outcomes
Primary Outcome Measures
Success rate of conversion to resection
The proportion of patients with initially unresectable large HCC who were evaluated by the surgical team as suitable for second-stage surgical resection after TACE treatment.
Secondary Outcome Measures
Objective response rate (ORR) of TACE treatment
The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR) which is assessed by the investigators according to modified Response Evaluaion Criteria in Solid Tumors (mRECIST).
Progression-free survival (PFS)
The time between the first TACE treatment and the first occurrence of disease progression (PD) or death from any cause, whichever occurs first. For the patients who receive surgical resection after TACE, PD is defined as tumor recurrence/metastasis after resection. For the patients who did not undergo surgical resection, PD is assessed by the investigators according to mRECIST.
Times of TACE procedure to achieve conversion
The number of TACE procedures performed for the patients when thier tumors become resectable. Resectability of the tumor is assessed by MDT during follow-up.
Time for successful conversion
The duration between the first TACE treatment and the resectability of the tumor. Resectability is assessed by MDT.
Disease-free survival (TFS) of the patients who undergo resection
The time between surgical resection and the first tumor recurrence/metastasis or death from any cause, whichever occurs first..
Adverse Events (AEs)
Number of patients with AE, treatment-related AE (TRAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0.
Overall survival (OS)
The time from first TACE until the date of death from any cause.
Full Information
NCT ID
NCT04967482
First Posted
July 8, 2021
Last Updated
September 14, 2022
Sponsor
Second Affiliated Hospital of Guangzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04967482
Brief Title
DEB-TACE vs. cTACE as Conversion Therapy for Unresectable Large HCC
Official Title
Drug-eluting Bead Transarterial Chemoembolization Compared With Conventional Transarterial Chemoembolization as the Conversion Therapy for Unresectable Large Hepatocellular Carcinoma: a Multicenter, Prospective, Nonrandomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 9, 2021 (Actual)
Primary Completion Date
July 8, 2024 (Anticipated)
Study Completion Date
July 8, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Guangzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is conducted to evaluate the efficacy of drug-eluting bead transarterial chemoembolization (DEB-TACE) compared with conventional transarterial chemoembolization (cTACE) as the conversion therapy for unresectable large hepatocellular carcinoma (HCC).
Detailed Description
This is a multicenter, prospective and nonrandomized study to evaluate the efficacy of DEB-TACE (with DC Bead) compared with cTACE as the conversion therapy for unresectable large HCC.
At least 216 patients (≥ 108 patients in each arm) with initially unresectable large HCC (> 7cm) will be enrolled in this study. The patients will receive either DEB-TACE or cTACE as the primary treatment according to their won will. TACE can be repeated on demand based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team, and the technique method of each TACE procedure (i.e. DEB-TACE or cTACE) for the same patient should be consistent. During follow-up, the potential resectability of the tumor will be assessed by the multidisciplinary team (MDT). Once the tumors become resectable, curative surgical resection will be recommended for the patients.
The primary end point of this study is success rate of conversion to resection. The secondary endpoints are objective response rate (ORR) of TACE, progression-free survival (PFS), times of TACE procedure to achieve conversion, conversion time, success rate of surgical resection, tumor recurrence rate after resection, tumor-free survival (TFS) of patients who undergo surgical resection, adverse events (AEs) and overall survival (OS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma Non-resectable
Keywords
Hepatocellular carcinoma, Transarterial chemoembolization, Conversion therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
216 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DEB-TACE
Arm Type
Experimental
Arm Description
DEB-TACE will be performed for the patients who choose DEB-TACE as the primary treatment.
Arm Title
cTACE
Arm Type
Active Comparator
Arm Description
cTACE will be performed for the patients who choose cTACE as the primary treatment.
Intervention Type
Procedure
Intervention Name(s)
Drug-eluting bead transarterial chemoembolization (DEB-TACE)
Intervention Description
The patients will receive DEB-TACE if they choose DEB-TACE as the primary treatment. DC Bead loaded with epirubicin (1 vial of DC Bead loaded with 60 mg of epirubicin) is used for chemoembolization. During follow-up, TACE will be repeated on demand based on the evaluation of the follow-up laboratory and imaging examination, and the technique method of each TACE procedure (i.e. DEB-TACE) for the same patient should be consistent.
Intervention Type
Procedure
Intervention Name(s)
Conventional transarterial chemoembolization (cTACE)
Intervention Description
The patients will receive cTACE if they choose cTACE as the primary treatment. An emulsion of epirubicin in lipiodol wiil be injected into the tumor feeding artery. Afterwards, microspheres or polyvinyl alcohol particles mixed with contrast agent will be administered intraarterially until arterial flow stasis was achieved. Generally, the dose of lipiodol and epirubicin should not exceed 30 mL and 60 mg for each procedure. During follow-up, TACE will be repeated on demand based on the evaluation of the follow-up laboratory and imaging examination, and the technique method of each TACE procedure (i.e. cTACE) for the same patient should be consistent.
Primary Outcome Measure Information:
Title
Success rate of conversion to resection
Description
The proportion of patients with initially unresectable large HCC who were evaluated by the surgical team as suitable for second-stage surgical resection after TACE treatment.
Time Frame
2 years.
Secondary Outcome Measure Information:
Title
Objective response rate (ORR) of TACE treatment
Description
The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR) which is assessed by the investigators according to modified Response Evaluaion Criteria in Solid Tumors (mRECIST).
Time Frame
2 years.
Title
Progression-free survival (PFS)
Description
The time between the first TACE treatment and the first occurrence of disease progression (PD) or death from any cause, whichever occurs first. For the patients who receive surgical resection after TACE, PD is defined as tumor recurrence/metastasis after resection. For the patients who did not undergo surgical resection, PD is assessed by the investigators according to mRECIST.
Time Frame
3 years.
Title
Times of TACE procedure to achieve conversion
Description
The number of TACE procedures performed for the patients when thier tumors become resectable. Resectability of the tumor is assessed by MDT during follow-up.
Time Frame
2 years.
Title
Time for successful conversion
Description
The duration between the first TACE treatment and the resectability of the tumor. Resectability is assessed by MDT.
Time Frame
2 years.
Title
Disease-free survival (TFS) of the patients who undergo resection
Description
The time between surgical resection and the first tumor recurrence/metastasis or death from any cause, whichever occurs first..
Time Frame
2 years.
Title
Adverse Events (AEs)
Description
Number of patients with AE, treatment-related AE (TRAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0.
Time Frame
3 years.
Title
Overall survival (OS)
Description
The time from first TACE until the date of death from any cause.
Time Frame
3 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hepatocellular carcinoma confirmed by histopathology and/or cytology, or diagnosed clinically.
The tumor lesion was only localized in one liver lobe.
Large HCC with single lesion > 7 cm, or multiple lesions.
unresectable HCC evaluated by the surgeon team.
The patient is suitable for TACE treatment, which is evaluated by MDT.
At least one measurable intrahepatic target lesion.
Patients without cirrhosis, or with cirrhosis but the liver function of Child-Pugh Class A.
ECOG score of performance status ≤ 1 point.
Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×109/L, absolute value of neutrophils >1.5×109/L, hemoglobin ≥85 g/L, total bilirubin ≤30 μmol/L, albumin ≥35 g/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR<1.5 or PT/APTT normal range.
Patients have the willingness to receive TACE as the conversion therapy for surgical resection.
Exclusion Criteria:
Accompanied with tumor thrombus involving the main portal vein, first-order branch or bilateral branches of portal vein.
Accompanied with hepatic vein and vena cava tumor thrombus.
The extent of the lesion exceeds one liver lobe or extrahepatic metastasis.
Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.
Those with organs (heart and kidneys) dysfunction who cannot tolerate TACE treatment and surgical hepatectomy.
History of other malignancies.
Uncontrollable infection.
Patients with active hepatitis B must undergo antiviral therapy to control HBV-DNA <10^3 IU/mL.
HCV patients need to complete the anti-HCV therapy before they are enrolled.
History of HIV.
Allergic to the drugs involved in the research.
Patients with gastrointestinal bleeding within 30 days, or other bleeding> CTCAE grade 3.
History of organ or cells transplantation. Previous treatment with TACE, intra-arterial infusion chemotherapy, radiotherapy, or systemic therapy
Those with bleeding tendency.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingyue Cai, Dr.
Phone
+86-20-34156205
Email
cai020@yeah.net
First Name & Middle Initial & Last Name or Official Title & Degree
Kangshun Zhu, Dr.
Phone
+86-20-34156205
Email
zhksh010@163.com
Facility Information:
Facility Name
the Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingyue Cai, Dr.
Phone
+86-20-34156205
Email
cai020@yeah.net
12. IPD Sharing Statement
Learn more about this trial
DEB-TACE vs. cTACE as Conversion Therapy for Unresectable Large HCC
We'll reach out to this number within 24 hrs