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

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: HepatoCellular Carcinoma

Treatments: Drug: 5-Fu, oxaliplatin , leucovorin

Study type: Interventional

Funder types: Other

Identifiers

NCT02987699

Unique Protocol ID: HCC-S026

Details and patient eligibility

About

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).

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 3 patient groups

Full Dosage

Experimental group

Description:

Full Dosage Chemotherapy regimen administered by HAI

Treatment:

Drug: 5-Fu, oxaliplatin , leucovorin

Drug: 5-Fu, oxaliplatin , leucovorin

Drug: 5-Fu, oxaliplatin , leucovorin

Low Dosage of 5-Fu

Experimental group

Description:

Low Dose of 5-Fu Chemotherapy regimen administered by HAI

Treatment:

Drug: 5-Fu, oxaliplatin , leucovorin

Drug: 5-Fu, oxaliplatin , leucovorin

Drug: 5-Fu, oxaliplatin , leucovorin

Low Dosage of oxaliplatin

Experimental group

Description:

Low Dose of oxaliplatin Chemotherapy regimen administered by HAI

Treatment:

Drug: 5-Fu, oxaliplatin , leucovorin

Drug: 5-Fu, oxaliplatin , leucovorin

Drug: 5-Fu, oxaliplatin , leucovorin