Sorafenib or Lenvatinib Plus HAIC of 130 mg/m² Oxaliplatin, and 5-fu vs Sorafenib or Lenvatinib Plus HAIC of 85mg/m² Oxaliplatin, and 5-fu for Unresectable Advanced HCC: a Randomised Phase 3 Trial

Sorafenib or Lenvatinib Plus Hepatic Artery Infusion of 130 mg/m² Oxaliplatin, Leucovorin, and Fluorouracil Versus Sorafenib or Lenvatinib Plus Hepatic Artery Infusion of 85 mg/m² Oxaliplatin, Leucovorin, and 1200 mg/m² Fluorouracil for Unresectable Advanced Hepatocellular Carcinoma: a Randomised Phase 3 Trial

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04687163

Enrollment

400

Registered

2020-12-29

Start date

2020-12-30

Completion date

2022-12-01

Last updated

2021-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Brief summary

A randomized trial showed that sorafenib plus hepatic artery infusion of 85mg/m² oxaliplatin, leucovorin and fluorouracil is more effective than sorafenib in advanced hepatocellular carcinoma. However, a retrospective study showed that hepatic artery infusion of 130 mg/m² oxaliplatin, leucovorin and fluorouracil is more effective than sorafenib in advanced hepatocellular carcinoma. It is unknown which oxaliplatin dose is better.

Interventions

DRUGHAIC of 130 mg/m² Oxaliplatin, and 5-fu

Hepatic arterial infusion of 130 mg/m² oxaliplatin,leucovorin and 2400 mg/m² 5-FU

DRUGHAIC of 85 mg/m² Oxaliplatin, and 5-fu

Hepatic arterial infusion of 85 mg/m² oxaliplatin,leucovorin and 2400 mg/m² 5-FU

DRUGTKI

sorafenib 400mg bid or lenvatinib 12 mg/day (for bodyweight ≥60 kg) or 8 mg/day (for bodyweight \<60 kg)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 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; * With vascular invasion or extrahepatic metastasis * 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

Design outcomes

Primary

Measure	Time frame
Overall survival	24 months

Secondary

Measure	Time frame	Description
progression-free survival	24 months	—
objective response rate	6 months	—
time to response	12 months	time to the date that patients achieved objective response
Adverse Events	30 Days after HAIC	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026