Trial | NCT03468231  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    300
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).
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.
Study Started
Mar 09
2018
Primary Completion
Sep 09
2019
Anticipated
Study Completion
Mar 09
2020
Anticipated
Last Update
Mar 16
2018

Drug Sorafenib

Oral Sorafenib, 400mg, Bid

Drug HAIC of FOLFOX [leucovorin, fluorouracil (efudex), oxaliplatin (eloxatin)]

administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

  • Other names: Oxaliplatin , fluorouracil, and leucovorin

Drug HAIC of OXA

administration of Oxaliplatin via the tumor feeding arteries

  • Other names: Oxaliplatin

Sorafenib plus HAIC of FOLFOX Active Comparator

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

Sorafenbi plus HAIC of OXA Experimental

Sorafenib combined with Hepatic arterial infusion chemotherapy with Oxaliplatin

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
No Results Posted