Actively Recruiting
HAIC With One-day FOLFOX vs. HAIC With Two-day FOLFOX for Unresectable HCC: a Non-inferiority Study
Led by Sun Yat-sen University · Updated on 2022-12-09
300
Participants Needed
3
Research Sites
218 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
G
Guangzhou No.12 People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HAIC With One-day FOLFOX vs. HAIC With Two-day FOLFOX for Unresectable HCC: a Non-inferiority Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Karnofsky Performance Status (KPS) of 70 or higher
- Diagnosis of hepatocellular carcinoma (HCC) according to European Association for the Study of the Liver criteria
- HCC staged as BCLC A, B, or C based on Barcelona Clinic Liver Cancer system
- At least one tumor lesion that can be accurately measured
- Unresectable HCC confirmed by a panel of liver surgery experts
- No cirrhosis or Child-Pugh class A cirrhosis only
- Laboratory values meeting all of the following: platelet count ≥ 75,000/μL; hemoglobin ≥ 8.5 g/dL; total bilirubin ≤ 30 mmol/L; serum albumin ≥ 32 g/L; AST and ALT ≤ 6 times upper limit of normal; serum creatinine ≤ 1.5 times upper limit of normal; INR > 2.3 or normal PT/APTT; absolute neutrophil count > 1,500/mm3
- Ability to understand the study protocol and provide written informed consent
You will not qualify if you...
- Clinically significant gastrointestinal bleeding within 30 days prior to study entry
- Serious heart disease such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Signs of liver decompensation including ascites, gastrointestinal bleeding, or hepatic encephalopathy
- Known HIV infection
- History of organ transplant
- Known or suspected allergy to study drugs or related agents
- Bleeding disorders or any hemorrhage event greater than Grade 3 within 4 weeks before the first study drug dose
- Serious non-healing wounds, ulcers, or bone fractures
- Known central nervous system tumors including brain metastases
- Poor compliance preventing adherence to treatment and follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The First People's Hospital of Foshan
Foshan, Guangdong, China, 510060
Actively Recruiting
2
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Actively Recruiting
3
Guangzhou Twelfth People 's Hospita
Guangzhou, Guangdong, China, 510620
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here