A Phase 3 interventional study of HAIC and FOLFOX 2d in Hepatocellular Carcinoma, sponsored by Sun Yat-sen University. Recruiting at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-12-09.
Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment
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.
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This study's planned enrollment of 300 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
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Oxaliplatin, leucovorin, and bolus fluorouracil were conducted equally in the both groups, while infusional fluorouracil 2400 mg/m² was given over 23 hours in the HAIC 1d group
Procedure: HAIC · Drug: FOLFOX 1d
Oxaliplatin, leucovorin, and bolus fluorouracil were conducted equally in the both groups, while infusional fluorouracil 2400 mg/m² was given over 46 hours in the HAIC 2d group
Procedure: HAIC · Drug: FOLFOX 2d
The microcatheter was advanced into the hepatic artery, and patients were transferred to the inpatient ward for drug infusion via the hepatic artery
Oxaliplatin, leucovorin, bolus fluorouracil, and infusional fluorouracil 2400 mg/m² over 46 hours
Oxaliplatin, leucovorin, bolus fluorouracil, and infusional fluorouracil 2400 mg/m² over 23 hours
Overall survival
time from randomzation to death
Time frame: 24 months
Progression-free survival
time from randomzation to progression or death, which occur firstly.
Time frame: 12 months
objective response rate per RECIST 1.1
CR plus PR per RECIST 1.1
Time frame: 12 months
Adverse Events
Adverse Events according to CTCAE 4.0
Time frame: 30 days
the predictive power of thymidylate synthase (TYMS)
the correlation between thymidylate synthase (TYMS) and survival. Whether the survival of patients with low TYMS is better than those with high TYMS
Time frame: 12 months
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