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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04667351

Collaborator

Kaiping Central Hospital (Other), Guangzhou No.12 People's Hospital (Other)

400

Enrollment

Locations

Arms

Anticipated Duration (Months)

133.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HepatoCellular Carcinoma	Drug: 2400 mg/m² 5-fu Drug: 1200 mg/m² 5-fu	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Hepatic Artery Infusion of Oxaliplatin, Leucovorin, and 2400 mg/m² Fluorouracil Versus Hepatic Artery Infusion of Oxaliplatin, Leucovorin, and 1200 mg/m² Fluorouracil for Unresectable Hepatocellular Carcinoma: a Randomised Phase 3 Non-inferiority Trial

Actual Study Start Date :

Mar 1, 2019

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 5-fu 2400	Drug: 2400 mg/m² 5-fu Hepatic arterial infusion of oxaliplatin,leucovorin and 2400 mg/m² 5-FU
Experimental: 5-fu 1200	Drug: 1200 mg/m² 5-fu Hepatic arterial infusion of oxaliplatin,leucovorin and 1200 mg/m² 5-FU

Arm

Intervention/Treatment

Active Comparator: 5-fu 2400

Drug: 2400 mg/m² 5-fu

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

Experimental: 5-fu 1200

Drug: 1200 mg/m² 5-fu

Hepatic arterial infusion of oxaliplatin,leucovorin and 1200 mg/m² 5-FU

Outcome Measures

Primary Outcome Measures

overall survival [24 months]

Secondary Outcome Measures

progression-free survival [24 months]
objective response rate [6 months]
disease control rate [6 months]
Adverse Events [30 Days after HAIC]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Center Sun Yat-sen University	Guangzhou	Guangdong	China	510060
2	Guangzhou Twelfth People 's Hospita	Guangzhou	Guangdong	China	510620
3	Kaiping Central Hospital	Kaiping	Guangdong	China	529300