Phase II Study of HAIC Using Cisplatin,Leucovorin and 5-Fluorouracil

Phase 2

• Conditions: HepatoCellular Carcinoma
• Interventions: Drug: 5-Fu, oxaliplatin , leucovorin

• Registration Number: NCT02987699
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The purpose of this phase II study is to determine the recommended dose, as well as the safety and efficacy of the combination of oxaliplatin, leucovorin and 5-Fu introduced by hepatic arterial infusion chemotherapy (HAIC) in patients with advanced hepatocellular carcinoma (HCC).

Detailed Description

The results of our preliminary pilot study suggested that the combination of oxaliplatin, leucovorin and 5-Fu introduced by hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for advanced stage HCC. Thus, the investigators carried out this prospective randomized control study to determine the recommended dose as well as the safety and efficacy.

Study Timeline

• Study Start: 2016-11
• Status Verified: 2016-12
• Study First Submitted: 2016-12-07
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-09
• Last Update Submitted: 2016-12-27
• Last Update Posted: 2016-12-28
• Primary Completion: 2017-04
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dosage of 5-Fu	5-Fu, oxaliplatin , leucovorin	Low Dose of 5-Fu Chemotherapy regimen administered by HAI
Low Dosage of oxaliplatin	5-Fu, oxaliplatin , leucovorin	Low Dose of oxaliplatin Chemotherapy regimen administered by HAI
Full Dosage	5-Fu, oxaliplatin , leucovorin	Full Dosage Chemotherapy regimen administered by HAI

Primary Outcome Measures

Name	Time	Method
Tumor response	3 Months	Tumor response evaluated by postoperative CT/MRI scan according to RECIST criteria.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	30 days	Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03
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 v4.03

Trial Locations

Locations (1)

Cancer Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China