Back to resultsthe Effect of Different Oxaliplatin Dose in Transarterial Infusion (TAI) in Unresectable Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transarterial infusion
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 hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
- not previous treated for tumor;
- unresectable;
- 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 surgery;
- 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 2
Arm Type
Experimental
Active Comparator
Arm Label
low dose
high dose
Arm Description
low oxaliplatin (85mg/m2)
high oxaliplatin (135mg/m2)
Outcomes
Primary Outcome Measures
OS
overall survival
Secondary Outcome Measures
ORR
object response rate
PFS
progression-free survival
Full Information
NCT ID
NCT03777475
First Posted
December 12, 2018
Last Updated
December 14, 2018
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT03777475
Brief Title
the Effect of Different Oxaliplatin Dose in Transarterial Infusion (TAI) in Unresectable Hepatocellular Carcinoma
Official Title
the Effect of Different Oxaliplatin Dose in Transarterial Infusion (TAI) in Unresectable Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
December 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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
evaluate the effect of different oxaliplatin dose in TAI in treating 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
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
low dose
Arm Type
Experimental
Arm Description
low oxaliplatin (85mg/m2)
Arm Title
high dose
Arm Type
Active Comparator
Arm Description
high oxaliplatin (135mg/m2)
Intervention Type
Procedure
Intervention Name(s)
transarterial infusion
Intervention Description
transarterial infusion
Primary 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 60 months
Secondary Outcome Measure Information:
Title
ORR
Description
object response rate
Time Frame
From date of randomization until the date of death from any cause, assessed up to 60 months
Title
PFS
Description
progression-free survival
Time Frame
From date of randomization until the date of progress from any cause, assessed up to 60 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 hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
not previous treated for tumor;
unresectable;
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 surgery;
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
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
Plan to Share IPD
Undecided
Learn more about this trial
the Effect of Different Oxaliplatin Dose in Transarterial Infusion (TAI) in Unresectable Hepatocellular Carcinoma
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