Phase Ⅱ Study of HAIC of FOLFOX vs. Sorafenib in HCC Refractory to TACE
Primary Purpose
Hepatocellular Carcinoma
Status
Withdrawn
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HAIC of FOLFOX
Sorafenib
Sponsored by

About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatic arterial infusion chemotherapy, Sorafenib
Eligibility Criteria
Inclusion Criteria:
- TACE failure or refractoriness based on the Liver Cancer Study Group of Japan (LCSGJ) criteria, including appearance of vascular invasion or two or more consecutive insufficient responses of the intrahepatic lesion;
- Except for TACE, patients have received no previous anti-tumor treatment;
- The diagnosis of HCC was based on histological results;
- Patients must have at least one tumor lesion that can be accurately measured;
- Not amendable to surgical resection ,local ablative therapy and any other cured treatment;
- No Cirrhosis or cirrhotic status of Child-Pugh class A only;
- No liver protection therapy in 2 weeks before enrolled, and meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL; (b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin ≥ 32 g/L;(e) ASL and AST ≤ 5 x upper limit of normal;(f) Serum creatinine ≤ 1.5 x upper limit of normal;(g) INR > 2.3 or PT/APTT within normal limits; (h) Absolute neutrophil count (ANC) >1,500/mm3;
- Ability to understand the protocol and to agree to and sign a written informed consent document
Exclusion Criteria:
- 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;
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.
Sites / Locations
- Guangzhou Twelfth People 's Hospital
- Ming Shi
- Kaiping Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HAIC of FOLFOX
Sorafenib
Arm Description
Hepatic arterial infusion chemotherapy with oxaliplatin, leucovorin, and 5-fluorouracil
Sorafenib 400 mg orally twice a day
Outcomes
Primary Outcome Measures
Progression-free survival
The period from the date of the start of HAIC or sorafenib until the date of the confirmation of tumor progression or death
Secondary Outcome Measures
Overall survival
The period from the date of the start of HAIC or sorafenib until the date of the confirmation of tumor progression or death
Adverse Events
Postoperative adverse events were graded based on CTCAE v4.03
Objective response rate
Best response based on mRECIST
Full Information
NCT ID
NCT03722498
First Posted
October 25, 2018
Last Updated
July 9, 2023
Sponsor
Sun Yat-sen University
Collaborators
Guangzhou No.12 People's Hospital, Kaiping Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03722498
Brief Title
Phase Ⅱ Study of HAIC of FOLFOX vs. Sorafenib in HCC Refractory to TACE
Official Title
Randomized Phase Ⅱ Study of Second-line Treatment Comparing Hepatic Arterial Infusion Chemotherapy of Oxaliplatin, 5-fluorouracil and Leucovorin With Sorafenib in Hepatocellular Carcinoma Refractory to Transarterial Chemoembolization
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Withdrawn
Why Stopped
No patients join
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
March 22, 2021 (Anticipated)
Study Completion Date
March 22, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Guangzhou No.12 People's Hospital, Kaiping Central Hospital
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
To evaluate safety and efficacy of combined hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin and sorafenib in hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization(TACE)
Detailed Description
In most current guidelines, sorafenib is considered as the second-line treatment for patients with transarterial chemoembolization(TACE) failure or refractoriness.However,the median overall survival of those treated with sorafenib monotherapy was 16.4 to 24.7 months.
Whether combining sorafenib with hepatic arterial infusion chemotherapy(HAIC) of oxaliplatin,5-fluorouracil and leucovorin is safe, well tolerated, and efficacious remains unknown, with no prospective clinical data currently available.The investigators therefore conducted a prospective and randomized phase II trial to compare the safety and efficacy of HAIC with sorafenib in patients refractory to TACE
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatic arterial infusion chemotherapy, Sorafenib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HAIC of FOLFOX
Arm Type
Experimental
Arm Description
Hepatic arterial infusion chemotherapy with oxaliplatin, leucovorin, and 5-fluorouracil
Arm Title
Sorafenib
Arm Type
Active Comparator
Arm Description
Sorafenib 400 mg orally twice a day
Intervention Type
Drug
Intervention Name(s)
HAIC of FOLFOX
Other Intervention Name(s)
Oxaliplatin , fluorouracil, and leucovorin
Intervention Description
administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
administration of Sorafenib
Primary Outcome Measure Information:
Title
Progression-free survival
Description
The period from the date of the start of HAIC or sorafenib until the date of the confirmation of tumor progression or death
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
The period from the date of the start of HAIC or sorafenib until the date of the confirmation of tumor progression or death
Time Frame
12 months
Title
Adverse Events
Description
Postoperative adverse events were graded based on CTCAE v4.03
Time Frame
30 Days after HAIC and TACE
Title
Objective response rate
Description
Best response based on mRECIST
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:
TACE failure or refractoriness based on the Liver Cancer Study Group of Japan (LCSGJ) criteria, including appearance of vascular invasion or two or more consecutive insufficient responses of the intrahepatic lesion;
Except for TACE, patients have received no previous anti-tumor treatment;
The diagnosis of HCC was based on histological results;
Patients must have at least one tumor lesion that can be accurately measured;
Not amendable to surgical resection ,local ablative therapy and any other cured treatment;
No Cirrhosis or cirrhotic status of Child-Pugh class A only;
No liver protection therapy in 2 weeks before enrolled, and meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL; (b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin ≥ 32 g/L;(e) ASL and AST ≤ 5 x upper limit of normal;(f) Serum creatinine ≤ 1.5 x upper limit of normal;(g) INR > 2.3 or PT/APTT within normal limits; (h) Absolute neutrophil count (ANC) >1,500/mm3;
Ability to understand the protocol and to agree to and sign a written informed consent document
Exclusion Criteria:
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;
Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Shi, MD
Organizational Affiliation
The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou Twelfth People 's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510620
Country
China
Facility Name
Ming Shi
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Kaiping Central Hospital
City
Kaiping
State/Province
Guangdong
ZIP/Postal Code
529300
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Phase Ⅱ Study of HAIC of FOLFOX vs. Sorafenib in HCC Refractory to TACE
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