Clinical trial NCT04667351: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HepatoCellular Carcinoma
Keywords: Hepatic arterial infusion chemotherapy
2400 mg/m² 5-fu
1200 mg/m² 5-fu
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Kaiping Central Hospital
name: Guangzhou No.12 People's Hospital
First posted: 2020-12-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: overall survival
timeFrame: 24 months
Secondary outcomes:
measure: progression-free survival
timeFrame: 24 months
measure: objective response rate
timeFrame: 6 months
measure: disease control rate
timeFrame: 6 months
measure: Adverse Events
timeFrame: 30 Days after HAIC
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Twelfth People 's Hospita
state: Guangdong
city: Kaiping
country: China
facility: Kaiping Central Hospital
state: Guangdong
Study officials:
References: