HAIC of FOLFOX vs. HAIC of OXA for Advanced HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

Sorafenib Plus Hepatic Artery Infusion Chemotherapy of Oxaliplatin, Fluorouracil/Leucovorin Versus Sorafenib Plus Hepatic Artery Infusion Chemotherapy of Oxaliplatin for Hepatocellular Carcinoma With Major Portal Vein Tumor Thrombosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03468231
• Other study ID #: HCC-20180309
• Status: Recruiting
• Phase: Phase 3
• First received: March 11, 2018
• Last updated: March 11, 2018
• Start date: March 9, 2018
• Est. completion date: March 9, 2020

Study information

• Verified date: March 2018
• Source: Sun Yat-sen University
• Contact: Ming Shi, MD
• Phone: (8620)-87343938
• Email: shiming[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin compared with HAIC of oxaliplatin alone in patients with hepatocellular carcinoma (HCC) with major portal venous tumor thrombus (PVTT).

Description:

Sorafenib is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients with portal venous tumor thrombus (PVTT). Our previous prospective study revealed that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin confer a survival benefit to HCC with major PVTT. However, HAIC of fluorouracil is not such for advanced HCC. Whether HAIC of oxaliplatin is as effective as HAIC of oxaliplatin plus fluorouracil/leucovorin is controversial. Thus, the investigators carried out this prospective randomized control study to find out it.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 9, 2020
• Est. primary completion date: September 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Sorafenib
Oral Sorafenib, 400mg, Bid
• HAIC of FOLFOX
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
• HAIC of OXA
administration of Oxaliplatin via the tumor feeding arteries

Locations

Country	Name	City	State
China	Dongguan People's Hospital	Dongguan	Guangdong
China	Cancer Center Sun Yat-sen University	Guangzhou	Guangdong
China	Guangzhou Twelfth People 's Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	First Affiliated Hospital of University Of South China	Hengyang	Hunan
China	Kaiping Central Hospital	Kaiping	Guangdong
China	The First Affiliated Hospital Of Xi'an Jiaotong University	Xi'an	Shanxi

Sponsors (7)

Lead Sponsor	Collaborator
Sun Yat-sen University	Dongguan People's Hospital, First Affiliated Hospital Xi'an Jiaotong University, First Affiliated Hospital, Sun Yat-Sen University, Guangzhou Twelfth People 's Hospital, Kaiping Central Hospital, The First Affiliated Hospital of University of South China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Overall survival	10 months
Secondary	Progress free survival	Progress free survival	10 months
Secondary	Adverse Events	Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.0	30 days
Secondary	Number of of Patients developed Adverse Events	Number of of patients who developed adverse event. Postoperative adverse events were graded based on CTCAE v4.0	30 days
Secondary	Tumor response	overall response	10 months