HAIC of FOLFOX Plus Sorafenib vs HAIC of FOLFIRINOX Plus Sorafenib for Advcanced HCC

Sponsor

Sun Yat-sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03812783

Collaborator

(none)

100

Enrollment

Location

Arms

12.8

Anticipated Duration (Months)

7.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin plus sorafenib compared with HAIC of irinotecan, oxaliplatin, 5-fluorouracil and leucovorin plus sorafenib in patients with advanced hepatocellular carcinoma (HCC)

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Procedure: Hepatic arterial infusion chemotherapy Drug: Folfox Protocol Drug: Sorafenib Procedure: Hepatic arterial infusion chemotherapy Drug: FOLFIRINOX	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Hepatic Arterial Infusion Chemotherapy of Oxaliplatin, 5-Fluorouracil and Leucovorin Plus Sorafenib Versus Hepatic Arterial Infusion Chemotherapy of Irinotecan, Oxaliplatin, 5-Fluorouracil and Leucovorin Plus Sorafenib for Advanced Hepatocellular Carcinoma

Actual Study Start Date :

Nov 5, 2018

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HAIC of FOLFIRINOX plus sorafenib	Drug: Sorafenib administration of Sorafenib Procedure: Hepatic arterial infusion chemotherapy administration of Irinotecan, Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries Drug: FOLFIRINOX Irinotecan, Oxaliplatin , fluorouracil, and leucovorin
Active Comparator: HAIC of FOLFOX plus sorafenib	Procedure: Hepatic arterial infusion chemotherapy administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries Drug: Folfox Protocol Oxaliplatin , fluorouracil, and leucovorin Drug: Sorafenib administration of Sorafenib

Arm

Intervention/Treatment

Experimental: HAIC of FOLFIRINOX plus sorafenib

Drug: Sorafenib

administration of Sorafenib

Procedure: Hepatic arterial infusion chemotherapy

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

Drug: FOLFIRINOX

Irinotecan, Oxaliplatin , fluorouracil, and leucovorin

Active Comparator: HAIC of FOLFOX plus sorafenib

Procedure: Hepatic arterial infusion chemotherapy

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

Drug: Folfox Protocol

Oxaliplatin , fluorouracil, and leucovorin

Drug: Sorafenib

administration of Sorafenib

Outcome Measures

Primary Outcome Measures

Overall Survival (OS) [12 months]
OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.

Secondary Outcome Measures

Progression Free Survival (PFS) [12 months]
PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.
Objective Response Rate (ORR) [12 months]
Objective Response Rate (ORR) ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on mRECIST. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference to the baseline sum of the diameters of target lesions.
Adverse Events [30 days]
Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.
Barcelona clinic liver cancer-stage C
Eastern Cooperative Oncology Group performance status of 0 to 2
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.
Known central nervous system tumors including metastatic brain disease