Phase Ⅱ Study of HAIC of FOLFOX vs. Sorafenib in HCC Refractory to TACE

NCT ID: NCT03722498

Last Updated: 2023-07-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2021-03-22

Brief Summary

To evaluate safety and efficacy of combined hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin and sorafenib in hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization(TACE)

Detailed Description

In most current guidelines, sorafenib is considered as the second-line treatment for patients with transarterial chemoembolization(TACE) failure or refractoriness.However,the median overall survival of those treated with sorafenib monotherapy was 16.4 to 24.7 months.

Whether combining sorafenib with hepatic arterial infusion chemotherapy(HAIC) of oxaliplatin,5-fluorouracil and leucovorin is safe, well tolerated, and efficacious remains unknown, with no prospective clinical data currently available.The investigators therefore conducted a prospective and randomized phase II trial to compare the safety and efficacy of HAIC with sorafenib in patients refractory to TACE

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HAIC of FOLFOX

Hepatic arterial infusion chemotherapy with oxaliplatin, leucovorin, and 5-fluorouracil

Group Type: EXPERIMENTAL

HAIC of FOLFOX

Intervention Type: DRUG

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

Sorafenib

Sorafenib 400 mg orally twice a day

Group Type: ACTIVE_COMPARATOR

Sorafenib

Intervention Type: DRUG

administration of Sorafenib

Interventions

HAIC of FOLFOX

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

Intervention Type: DRUG

Sorafenib

administration of Sorafenib

Intervention Type: DRUG

Other Intervention Names

Oxaliplatin , fluorouracil, and leucovorin

Eligibility Criteria

Inclusion Criteria

• TACE failure or refractoriness based on the Liver Cancer Study Group of Japan (LCSGJ) criteria, including appearance of vascular invasion or two or more consecutive insufficient responses of the intrahepatic lesion;
• Except for TACE, patients have received no previous anti-tumor treatment;
• The diagnosis of HCC was based on histological results;
• Patients must have at least one tumor lesion that can be accurately measured;
• Not amendable to surgical resection ,local ablative therapy and any other cured treatment;
• No Cirrhosis or cirrhotic status of Child-Pugh class A only;
• No liver protection therapy in 2 weeks before enrolled, and meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL; (b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin ≥ 32 g/L;(e) ASL and AST ≤ 5 x upper limit of normal;(f) Serum creatinine ≤ 1.5 x upper limit of normal;(g) INR > 2.3 or PT/APTT within normal limits; (h) 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;
• Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou No.12 People's Hospital

OTHER_GOV

Sponsor Role: collaborator

Kaiping Central Hospital

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Shi Ming

Proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Shi, MD

Role: PRINCIPAL_INVESTIGATOR

The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center

Locations

Guangzhou Twelfth People 's Hospital

Guangzhou, Guangdong, China

Ming Shi

Guangzhou, Guangdong, China

Kaiping Central Hospital

Kaiping, Guangdong, China

Countries

China

Other Identifiers

HCC-H171011

Identifier Type: -

Identifier Source: org_study_id