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

Phase 2

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Folfox Protocol; Procedure: Hepatic arterial infusion chemotherapy; Drug: Sorafenib; Drug: FOLFIRINOX

• Registration Number: NCT03812783
• 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, 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-05
• Status Verified: 2019-01
• Study First Submitted: 2019-01-19
• Study First Submitted QC: 2019-01-19
• Last Update Submitted: 2019-01-19
• Study First Posted: 2019-01-23
• Last Update Posted: 2019-01-23
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HAIC of FOLFOX plus sorafenib	Folfox Protocol	-
HAIC of FOLFOX plus sorafenib	Sorafenib	-
HAIC of FOLFIRINOX plus sorafenib	Hepatic arterial infusion chemotherapy	-
HAIC of FOLFIRINOX plus sorafenib	FOLFIRINOX	-
HAIC of FOLFOX plus sorafenib	Hepatic arterial infusion chemotherapy	-
HAIC of FOLFIRINOX plus sorafenib	Sorafenib	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

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