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

Sun Yat-sen University

Status and phase

Unknown

Phase 3

Conditions

HepatoCellular Carcinoma

Treatments

Drug: 1200 mg/m² 5-fu

Drug: 2400 mg/m² 5-fu

Study type

Interventional

Funder types

Other

Identifiers

NCT04667351

SH-1

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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