Clinical trial NCT03468231: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Hepatic arterial infusion chemotherapy
Sorafenib
Oxaliplatin plus Fluorouracil/Leucovorin
Oxaliplatin
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Dongguan People's Hospital
name: Kaiping Central Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: Guangzhou No.12 People's Hospital
name: The First Affiliated Hospital of University of South China
First posted: 2018-03-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall survival
timeFrame: 10 months
Secondary outcomes:
measure: Progress free survival
timeFrame: 10 months
measure: Adverse Events
timeFrame: 30 days
measure: Number of of Patients developed Adverse Events
timeFrame: 30 days
measure: Tumor response
timeFrame: 10 months
Other outcomes:
Locations:
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Cancer Center Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Twelfth People 's Hospital
state: Guangdong
city: Kaiping
country: China
facility: Kaiping Central Hospital
state: Guangdong
city: Hengyang
country: China
facility: First Affiliated Hospital of University Of South China
state: Hunan
city: Xi'an
country: China
facility: The First Affiliated Hospital Of Xi'an Jiaotong University
state: Shanxi
Study officials:
affiliation: The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center
name: Ming Shi, MD
role: PRINCIPAL_INVESTIGATOR
References: