Status:
UNKNOWN
HAIC of FOLFOX vs. HAIC of OXA for Advanced HCC
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
First Affiliated Hospital, Sun Yat-Sen University
Dongguan People's Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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...
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 comb...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 9 2020
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03468231
Start Date
March 9 2018
End Date
March 9 2020
Last Update
March 16 2018
Active Locations (7)
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1
Dongguan People's Hospital
Dongguan, Guangdong, China, 523059
2
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
3
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
4
Guangzhou Twelfth People 's Hospital
Guangzhou, Guangdong, China, 510620