Clinical trial NCT03722498: Phase Ⅱ Study of HAIC of FOLFOX vs. Sorafenib in HCC Refractory to TACE
Official title: Randomized Phase Ⅱ Study of Second-line Treatment Comparing Hepatic Arterial Infusion Chemotherapy of Oxaliplatin, 5-fluorouracil and Leucovorin With Sorafenib in Hepatocellular Carcinoma Refractory to Transarterial Chemoembolization
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Hepatic arterial infusion chemotherapy
Sorafenib
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Guangzhou No.12 People's Hospital
name: Kaiping Central Hospital
First posted: 2018-10-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Progression-free survival
timeFrame: 12 months
Secondary outcomes:
measure: Overall survival
timeFrame: 12 months
measure: Adverse Events
timeFrame: 30 Days after HAIC and TACE
measure: Objective response rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Twelfth People 's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Ming Shi
state: Guangdong
city: Kaiping
country: China
facility: Kaiping Central Hospital
state: Guangdong
Study officials:
affiliation: The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center
name: Ming Shi, MD
role: PRINCIPAL_INVESTIGATOR
References: