Back to resultsThe Efficacy of Transarterial Chemoinfusion (TAI) Combine Stereotactic Body Radiation Therapy (SBRT) in Unresectable Hepatocellular Carcinoma (HCC)
Primary Purpose
Hepatocellular Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TAI combine SBRT
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- older than 18 years old and younger than 75 years;
- ECOG PS≤1;
- proven advanced hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
- not previous treated for tumor;
- cannot accepted hepatectomy;
the lab test could meet:
- neutrophil count≥2.0×109/L;
- hemoglobin≥100g/L;
- platelet count≥75×109/L;
- serum albumin≥35g/L;
- total bilirubin<2-times upper limit of normal;
- ALT<3-times upper limit of normal;
- AST<3-times upper limit of normal;
- serum creatine<1.5-times upper limit of normal;
- PT≤upper limit of normal plus 4 seconds;
- INR≤2.2;
- sign up consent.
Exclusion Criteria:
- cannot tolerate TAI or SBRT;
- known history of other malignancy;
- be allergic to related drugs;
- underwent organ transplantation before;
- be treated before (interferon included);
- known history of HIV infection;
- known history of drug or alcohol abuse;
- have GI hemorrhage or cardiac/brain vascular events within 30 days;
- pregnancy.
Sites / Locations
- SUN YAT-SEN University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment group
Arm Description
TAI combine SBRT
Outcomes
Primary Outcome Measures
PFS
progression-free survival
ORR
objective response rate
Secondary Outcome Measures
OS
overall survival
DCR
disease control rate
Full Information
NCT ID
NCT03851887
First Posted
February 21, 2019
Last Updated
February 21, 2019
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT03851887
Brief Title
The Efficacy of Transarterial Chemoinfusion (TAI) Combine Stereotactic Body Radiation Therapy (SBRT) in Unresectable Hepatocellular Carcinoma (HCC)
Official Title
The Efficacy of Transarterial Chemoinfusion (TAI) Combine Stereotactic Body Radiation Therapy (SBRT) in Unresectable Hepatocellular Carcinoma (HCC): A Prospective, Single-armed, Stage II Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
January 31, 2020 (Anticipated)
Study Completion Date
January 31, 2022 (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
5. Study Description
Brief Summary
To evaluate the efiicacy of TAI combine SBRT in unresectable HCC
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
TAI combine SBRT
Intervention Type
Combination Product
Intervention Name(s)
TAI combine SBRT
Intervention Description
TAI combine SBRT
Primary Outcome Measure Information:
Title
PFS
Description
progression-free survival
Time Frame
From date of randomization until the date of progression, assessed up to 36 months
Title
ORR
Description
objective response rate
Time Frame
From date of randomization until the date of death, assessed up to 36 months
Secondary Outcome Measure Information:
Title
OS
Description
overall survival
Time Frame
From date of randomization until the date of death from any cause, assessed up to 36 months
Title
DCR
Description
disease control rate
Time Frame
From date of randomization until the date of death, assessed up to 36 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:
older than 18 years old and younger than 75 years;
ECOG PS≤1;
proven advanced hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
not previous treated for tumor;
cannot accepted hepatectomy;
the lab test could meet:
neutrophil count≥2.0×109/L;
hemoglobin≥100g/L;
platelet count≥75×109/L;
serum albumin≥35g/L;
total bilirubin<2-times upper limit of normal;
ALT<3-times upper limit of normal;
AST<3-times upper limit of normal;
serum creatine<1.5-times upper limit of normal;
PT≤upper limit of normal plus 4 seconds;
INR≤2.2;
sign up consent.
Exclusion Criteria:
cannot tolerate TAI or SBRT;
known history of other malignancy;
be allergic to related drugs;
underwent organ transplantation before;
be treated before (interferon included);
known history of HIV infection;
known history of drug or alcohol abuse;
have GI hemorrhage or cardiac/brain vascular events within 30 days;
pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaohua Li, MD
Phone
+8615088064187
Email
lishaoh@sysucc.org.cn
Facility Information:
Facility Name
SUN YAT-SEN University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rong-Ping Guo, M.D.
Phone
00862087342266
Email
guorp@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Wei Wei, Ph.D. M.D.
Phone
00862087343790
Email
weiwei@sysucc.org.cn
12. IPD Sharing Statement
Learn more about this trial
The Efficacy of Transarterial Chemoinfusion (TAI) Combine Stereotactic Body Radiation Therapy (SBRT) in Unresectable Hepatocellular Carcinoma (HCC)
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