Hepatocellular Carcinoma Clinical Trial
Official title:
Hepatic Arterial Infusion Chemotherapy as Adjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma(HCC): A Prospective Randomized Controlled Clinical Trial
To study if the addition of HAIC following complete removal of early stage liver cancer of HCC will prevent or delay the recurrence of the disease. Half of the participant will receive two cycles of the HAIC after the hepatectomy, while the other half will return to the baseline surveillance schedule.
The high incidence of HCC recurrence following liver resection is a serious issue. The
recurrent rate is as high as 50-60% at 3 years and 70-100% at 5 years.
So to reduce the recurrence rate of HCC, some interventions had been tried in clinic,
including transarterial chemoembolization (TACE), immunotherapy, and interferon treatment
etc. But few of these adjuvant therapies had been proved effective and the long term efficacy
and clinical application remained further explored.
HAIC had been prove to be effective adjuvant treatment in patients with liver metastasis of
colorectal cancers in randomized controlled trials and meta-analysis, but the role of
adjuvant HAIC after liver resection is controversial. The results getting from different
randomized control trials varied significantly because of the bias of patient selection,
different study design,the small size of sample, different drug used in chemotherapy and lack
of proper stratification,so a big sample size, well patients selected and well designed
randomized controlled trial is needed to further confirm the role of the postoperative HAIC.
Patients with HCC who received curative liver resection (R0) were randomly assigned 1:1 by
the doctors to receive no adjuvant HAIC(control group) or HAIC (treatment group). All
patients in the treatment group will receive 2 cycles of adjuvant HAIC within 3 months after
liver resection. The outcomes of patients were evaluated during the 5-years follow up.
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