Hepatocellular Carcinoma
Conditions
Brief summary
Hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin&5-fluorouracil was effective in unresectable hepatocellular carcinoma (HCC). The program of FOLFOX-HAIC in HCC was performed for 1 day (HAIC 1d) or 2 days (HAIC 2d). We hereby retrospectively compared the efficacy and safety between these two treatment regimens, and explored the predictive power of thymidylate synthase (TYMS), an enzyme involved in the DNA synthesis process and metabolism of fluorouracil. Patients with HCC staged BCLC A-B receive HAIC only, and patients with HCC staged BCLC C receive HAIC plus systemic treatment, such as sorafenib, A+T, lenvatinib.
Interventions
PROCEDUREHAIC
The microcatheter was advanced into the hepatic artery, and patients were transferred to the inpatient ward for drug infusion via the hepatic artery
DRUGFOLFOX 2d
Oxaliplatin, leucovorin, bolus fluorouracil, and infusional fluorouracil 2400 mg/m² over 46 hours
DRUGFOLFOX 1d
Oxaliplatin, leucovorin, bolus fluorouracil, and infusional fluorouracil 2400 mg/m² over 23 hours
Sponsors
Guangzhou No.12 People's Hospital
First People's Hospital of Foshan
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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), simultaneously staged as BCLC A, BCLC B or BCLC C based on Barcelona Clinic Liver Cancer staging system. * 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 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 * Serious non-healing wound, ulcer, or bone fracture * Known central nervous system tumors including metastatic brain disease * Poor compliance that can not comply with the course of treatment and follow up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 24 months | time from randomzation to death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 12 months | time from randomzation to progression or death, which occur firstly. |
| objective response rate per RECIST 1.1 | 12 months | CR plus PR per RECIST 1.1 |
| Adverse Events | 30 days | Adverse Events according to CTCAE 4.0 |
| the predictive power of thymidylate synthase (TYMS) | 12 months | the correlation between thymidylate synthase (TYMS) and survival. Whether the survival of patients with low TYMS is better than those with high TYMS |
Countries
China
Outcome results
None listed