HAIC of FOLFOX vs. HAIC of OXA for Advanced HCC
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Registration Number
- NCT03468231
- Lead Sponsor
- Sun Yat-sen University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sorafenib plus HAIC of FOLFOX HAIC of FOLFOX Sorafenib combined with Hepatic arterial infusion chemotherapy with Oxaliplatin, Fluorouracil and Leucovorin Sorafenbi plus HAIC of OXA HAIC of OXA Sorafenib combined with Hepatic arterial infusion chemotherapy with Oxaliplatin Sorafenib plus HAIC of FOLFOX Sorafenib Sorafenib combined with Hepatic arterial infusion chemotherapy with Oxaliplatin, Fluorouracil and Leucovorin Sorafenbi plus HAIC of OXA Sorafenib Sorafenib combined with Hepatic arterial infusion chemotherapy with Oxaliplatin
- Primary Outcome Measures
Name Time Method Overall survival 10 months Overall survival
- Secondary Outcome Measures
Name Time Method Progress free survival 10 months Progress free survival
Adverse Events 30 days Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.0
Number of of Patients developed Adverse Events 30 days Number of of patients who developed adverse event. Postoperative adverse events were graded based on CTCAE v4.0
Tumor response 10 months overall response
Trial Locations
- Locations (7)
Cancer Center Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
First Affiliated Hospital of University Of South China
🇨🇳Hengyang, Hunan, China
Dongguan People's Hospital
🇨🇳Dongguan, Guangdong, China
Guangzhou Twelfth People 's Hospital
🇨🇳Guangzhou, Guangdong, China
Kaiping Central Hospital
🇨🇳Kaiping, Guangdong, China
The First Affiliated Hospital Of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China