HAIC of Oxaliplatin, and 2400 mg/m² 5-fu vs HAIC of Oxaliplatin, and 1200 mg/m² 5-fu for Unresectable HCC: a Randomised Phase 3 Non-inferiority Trial

Phase 3

• Conditions: HepatoCellular Carcinoma
• Interventions: Drug: 1200 mg/m² 5-fu; Drug: 2400 mg/m² 5-fu

• Registration Number: NCT04667351
• Lead Sponsor: Sun Yat-sen University

Brief Summary

Hepatic artery infusion of oxaliplatin, leucovorin and 2400 mg/m² fluorouracil is effective in hepatocellular carcinoma. However, SILIUS study showed that sorafenib plus hepatic artery infusion of cisplatin and fluorouracil did not significantly improve overall survival compared with sorafenib alone. Whether fluorouracil is effevtive is known.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-09
• Last Update Submitted: 2020-12-09
• Study First Posted: 2020-12-14
• Last Update Posted: 2020-12-14
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Age range from 18-75 years;

• KPS≥70;

• 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;

• Diagnosed as unresectable with consensus by the panel of liver surgery experts;

• No past history of TACE, HAIC, chemotherapy or molecule-targeted treatment;

• No Cirrhosis or cirrhotic status of Child-Pugh class A only

• 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 ≤ 6 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

• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
• Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• 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.
• Evidence of bleeding diathesis.
• Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5-fu 1200	1200 mg/m² 5-fu	-
5-fu 2400	2400 mg/m² 5-fu	-

Primary Outcome Measures

Name	Time	Method
overall survival	24 months

Secondary Outcome Measures

Name	Time	Method
Adverse Events	30 Days after HAIC
progression-free survival	24 months
objective response rate	6 months
disease control rate	6 months

Trial Locations

Locations (3)

Guangzhou Twelfth People 's Hospita; 🇨🇳 Guangzhou, Guangdong, China

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

Kaiping Central Hospital; 🇨🇳 Kaiping, Guangdong, China