HAIC of FOLFOX vs. HAIC of OXA for Advanced HCC
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
1 other identifier
interventional
300
1 country
7
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hepatocellular-carcinoma
Started Mar 2018
Shorter than P25 for phase_3 hepatocellular-carcinoma
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 9, 2018
CompletedFirst Submitted
Initial submission to the registry
March 11, 2018
CompletedFirst Posted
Study publicly available on registry
March 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 9, 2020
CompletedMarch 16, 2018
March 1, 2018
1.5 years
March 11, 2018
March 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
Overall survival
10 months
Secondary Outcomes (4)
Progress free survival
10 months
Adverse Events
30 days
Number of of Patients developed Adverse Events
30 days
Tumor response
10 months
Study Arms (2)
Sorafenib plus HAIC of FOLFOX
ACTIVE COMPARATORSorafenib combined with Hepatic arterial infusion chemotherapy with Oxaliplatin, Fluorouracil and Leucovorin
Sorafenbi plus HAIC of OXA
EXPERIMENTALSorafenib combined with Hepatic arterial infusion chemotherapy with Oxaliplatin
Interventions
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
administration of Oxaliplatin via the tumor feeding arteries
Eligibility Criteria
You may qualify if:
- 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
- +2 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sun Yat-sen Universitylead
- First Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Dongguan People's Hospitalcollaborator
- Kaiping Central Hospitalcollaborator
- First Affiliated Hospital Xi'an Jiaotong Universitycollaborator
- Guangzhou No.12 People's Hospitalcollaborator
- The First Affiliated Hospital of University of South Chinacollaborator
Study Sites (7)
Dongguan People's Hospital
Dongguan, Guangdong, 523059, China
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
Guangzhou Twelfth People 's Hospital
Guangzhou, Guangdong, 510620, China
Kaiping Central Hospital
Kaiping, Guangdong, 529300, China
First Affiliated Hospital of University Of South China
Hengyang, Hunan, 421001, China
The First Affiliated Hospital Of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ming Shi, MD
The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- In the OXA group, saline replace the fluorouracil and leucovorin solution and patients are treated the same time as the FOLFOX group.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 11, 2018
First Posted
March 16, 2018
Study Start
March 9, 2018
Primary Completion
September 9, 2019
Study Completion
March 9, 2020
Last Updated
March 16, 2018
Record last verified: 2018-03