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HAIC of FOLFOX vs. HAIC of OXA for Advanced HCC

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Sorafenib
HAIC of FOLFOX
HAIC of OXA
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Hepatic arterial infusion chemotherapy, Sorafenib, Oxaliplatin plus Fluorouracil/Leucovorin, Oxaliplatin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)

  • Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
  • diagnosed with major or main portal vein invasion (Vp3 or Vp4)
  • KPS≥70；
  • with no previous treatment
  • No Cirrhosis or cirrhotic status of Child-Pugh class A only
  • Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
  • The following laboratory parameters:
  • Platelet count ≥ 75,000/µL
  • Hemoglobin ≥ 8.5 g/dL
  • Total bilirubin ≤ 30mmol/L
  • Serum albumin ≥ 30 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
  • 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
  • Evidence of bleeding diathesis.
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
  • Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
  • Serious non-healing wound, ulcer, or bone fracture
  • Known central nervous system tumors including metastatic brain disease

Sites / Locations

  • Dongguan People's HospitalRecruiting
  • Cancer Center Sun Yat-sen UniversityRecruiting
  • The First Affiliated Hospital, Sun Yat-sen UniversityRecruiting
  • Guangzhou Twelfth People 's HospitalRecruiting
  • Kaiping Central HospitalRecruiting
  • First Affiliated Hospital of University Of South ChinaRecruiting
  • The First Affiliated Hospital Of Xi'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Sorafenib plus HAIC of FOLFOX

Sorafenbi plus HAIC of OXA

Arm Description

Sorafenib combined with Hepatic arterial infusion chemotherapy with Oxaliplatin, Fluorouracil and Leucovorin

Sorafenib combined with Hepatic arterial infusion chemotherapy with Oxaliplatin

Outcomes

Primary Outcome Measures

Overall survival
Overall survival

Secondary Outcome Measures

Progress free survival
Progress free survival
Adverse Events
Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.0
Number of of Patients developed Adverse Events
Number of of patients who developed adverse event. Postoperative adverse events were graded based on CTCAE v4.0
Tumor response
overall response

Full Information

First Posted
March 11, 2018
Last Updated
March 11, 2018
Sponsor
Sun Yat-sen University
Collaborators
First Affiliated Hospital, Sun Yat-Sen University, Dongguan People's Hospital, Kaiping Central Hospital, First Affiliated Hospital Xi'an Jiaotong University, Guangzhou No.12 People's Hospital, The First Affiliated Hospital of University of South China
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1. Study Identification

Unique Protocol Identification Number
NCT03468231
Brief Title
HAIC of FOLFOX vs. HAIC of OXA for Advanced HCC
Official Title
Sorafenib Plus Hepatic Artery Infusion Chemotherapy of Oxaliplatin, Fluorouracil/Leucovorin Versus Sorafenib Plus Hepatic Artery Infusion Chemotherapy of Oxaliplatin for Hepatocellular Carcinoma With Major Portal Vein Tumor Thrombosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 9, 2018 (Actual)
Primary Completion Date
September 9, 2019 (Anticipated)
Study Completion Date
March 9, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
First Affiliated Hospital, Sun Yat-Sen University, Dongguan People's Hospital, Kaiping Central Hospital, First Affiliated Hospital Xi'an Jiaotong University, Guangzhou No.12 People's Hospital, The First Affiliated Hospital of University of South China

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
The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin compared with HAIC of oxaliplatin alone in patients with hepatocellular carcinoma (HCC) with major portal venous tumor thrombus (PVTT).
Detailed Description
Sorafenib is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients with portal venous tumor thrombus (PVTT). Our previous prospective study revealed that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin confer a survival benefit to HCC with major PVTT. However, HAIC of fluorouracil is not such for advanced HCC. Whether HAIC of oxaliplatin is as effective as HAIC of oxaliplatin plus fluorouracil/leucovorin is controversial. Thus, the investigators carried out this prospective randomized control study to find out it.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular Carcinoma, Hepatic arterial infusion chemotherapy, Sorafenib, Oxaliplatin plus Fluorouracil/Leucovorin, Oxaliplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
In the OXA group, saline replace the fluorouracil and leucovorin solution and patients are treated the same time as the FOLFOX group.
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sorafenib plus HAIC of FOLFOX
Arm Type
Active Comparator
Arm Description
Sorafenib combined with Hepatic arterial infusion chemotherapy with Oxaliplatin, Fluorouracil and Leucovorin
Arm Title
Sorafenbi plus HAIC of OXA
Arm Type
Experimental
Arm Description
Sorafenib combined with Hepatic arterial infusion chemotherapy with Oxaliplatin
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
Oral Sorafenib, 400mg, Bid
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)
HAIC of OXA
Other Intervention Name(s)
Oxaliplatin
Intervention Description
administration of Oxaliplatin via the tumor feeding arteries
Primary Outcome Measure Information:
Title
Overall survival
Description
Overall survival
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Progress free survival
Description
Progress free survival
Time Frame
10 months
Title
Adverse Events
Description
Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.0
Time Frame
30 days
Title
Number of of Patients developed Adverse Events
Description
Number of of patients who developed adverse event. Postoperative adverse events were graded based on CTCAE v4.0
Time Frame
30 days
Title
Tumor response
Description
overall response
Time Frame
10 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: The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL) Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria. diagnosed with major or main portal vein invasion (Vp3 or Vp4) KPS≥70； with no previous treatment No Cirrhosis or cirrhotic status of Child-Pugh class A only Not amendable to surgical resection ,local ablative therapy and any other cured treatment. The following laboratory parameters: Platelet count ≥ 75,000/µL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 30 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 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 Evidence of bleeding diathesis. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug Serious non-healing wound, ulcer, or bone fracture Known central nervous system tumors including metastatic brain disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Shi, MD
Phone
(8620)-87343938
Email
shiming@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
RongPing Guo, MD
Phone
(8620)-87342266
Email
guorp@sysucc.org.cn
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
Dongguan People's Hospital
City
Dongguan
State/Province
Guangdong
ZIP/Postal Code
523059
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wusheng Yu, MD
Phone
13827285010
Email
yuwusheng1998@126.com
Facility Name
Cancer Center Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Shi, MD
Phone
86-2087343115
Email
shiming@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Ming Shi, MD
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guosheng Tan, MD
Phone
13725254145
Email
tgs1976@163.com
Facility Name
Guangzhou Twelfth People 's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510620
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanmin Zhou, MD
Phone
15521278919
Email
13430288977@139.com
First Name & Middle Initial & Last Name & Degree
Jinghua Chen, MD
Facility Name
Kaiping Central Hospital
City
Kaiping
State/Province
Guangdong
ZIP/Postal Code
529300
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shijie Zhang, MD
Phone
13717287622
Email
Shijie_9262511@163.com
Facility Name
First Affiliated Hospital of University Of South China
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
421001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoping Wu, MD
Phone
13975486015
Email
wxp19730806@sina.com
Facility Name
The First Affiliated Hospital Of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Zheng, MD
Phone
13649265446
Email
183421344@qq.com

12. IPD Sharing Statement

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HAIC of FOLFOX vs. HAIC of OXA for Advanced HCC

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