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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04687163
• Other study ID #: SH-3
• Status: Recruiting
• Phase: Phase 3
• Start date: December 30, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: December 2020
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• HAIC of 130 mg/m² Oxaliplatin, and 5-fu
Hepatic arterial infusion of 130 mg/m² oxaliplatin,leucovorin and 2400 mg/m² 5-FU
• HAIC of 85 mg/m² Oxaliplatin, and 5-fu
Hepatic arterial infusion of 85 mg/m² oxaliplatin,leucovorin and 2400 mg/m² 5-FU
• TKI
sorafenib 400mg bid or lenvatinib 12 mg/day (for bodyweight =60 kg) or 8 mg/day (for bodyweight <60 kg)

Locations

Country	Name	City	State
China	Cancer Center Sun Yat-sen University	Guangzhou	Guangdong
China	Guangzhou Twelfth People 's Hospita	Guangzhou	Guangdong
China	Kaiping Central Hospital	Kaiping	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-sen University	Guangzhou No.12 People's Hospital, Kaiping Central Hospital

Country where clinical trial is conducted

China, 

Outcome

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