Hepatocellular Carcinoma Clinical Trial
Official title:
Effect of Babaodan in Preventing Tumor Recurrence After Hepatectomy for Hepatocellular Carcinoma: a Multicenter, Randomized, Placebo-controlled, Double-blind Trial
The aim of this study is to evaluate the effect of traditional Chinese medicine Babaodan on tumor recurrence of hepatocellular carcinoma after curative resection, as well as the safety of this treatment
Hepatocellular carcinoma (HCC) is the sixth most common malignancy and third leading cause of
cancer-related mortality worldwide. Partial hepatectomy and liver transplantation are
potential curative treatments for selected patients with HCC. Unfortunately, long-term
surgical outcomes remain unsatisfactory due to high tumor recurrence rates, which has been
reported to 40%-70%.
There are few methods for the prevention of HCC recurrence following curative-intent therapy,
and no standard treatment has been established so far for recurrent tumor. The effective
prevention of recurrence is the key to improve the management of this fatal malignancy. The
protective role of transarterial chemoembolization (TACE) has been confirmed in advanced HCC,
but the value of it as an adjuvant therapy is still controversial, which is mainly reflected
in the inconsistent conclusions of the randomized controlled trials and the retrospective
studies. Most prospective studies demonstrated that TACE was not effective or even harmful to
postoperative tumor recurrence. Lai et al used combination therapy (lipiodol, cisplatin and
epirubicin) as an adjuvant method for HCC patients after hepatectomy, and showed that the
3-year overall survival rate did not improve (66% vs. 65%), and the 3-year disease-free
survival rate even decreased (18% vs. 48%) for the treatment group compared with the control
group. However, retrospective studies indicate that postoperative adjuvant TACE is effective
in preventing recurrence.
Immunotherapy shows its potential anti-tumor value, but its exact effect still needs further
confirmation and the treatment standards is still uncertain. Compared with other solid
tumors, liver cancer often has a background of hepatitis B virus (HBV) infection, so
immunotherapy (such as thymosin, interferon) theoretically can simultaneously enhance the
anti-tumor and anti HBV immunity, and even reduce tumor recurrence. Studies have reported
that interferon treatment can improve the disease-free survival and overall survival of
selected patients. Oral nucleoside antiviral drugs can improve the disease-free survival of
HCC, because the hepatitis activity affects prognosis. But, the above results still need to
be verified by large sample clinical trials.
Babaodan, a mixed powder of traditional Chinese medicine containing eight constituents,
including natural calculus bovis, snake gall, antelope horn, pearl, musk, radix notoginseng
and so on. The formula of Babaodan was protected by Chinese Food and Drug Administration. It
has been widely used as a complementary and alternative medicine to treat chronic liver
diseases, mitigate the side effects and enhance the efficacy of chemotherapeutic drugs, and
promote cellular immunity. Lei et al reported that Babaodan can ameliorate liver injury and
fibrosis in rat hepatic fibrosis model induced by diethylnitrosamine, and have no obvious
side effect in normal rat livers. They also found that Babaodan did not influence the
absorption of lipopolysaccharide (LPS) in liver by analysing serum from portal vein.
Meanwhile, the results illustrated Babaodan can inhibit LPS-induced HSCs activation and
proliferation in vitro through TLR4/NF-κB and TLR4/ERK signaling pathway, respectively. Upon
these results, Babaodan may be a novel therapeutic choice for hepatic fibrosis. It also has
been reported to have an effect of inhibiting the occurrence and development of HCC. However,
the effect of Babaodan in preventing tumor recurrence is unclear.
In view of this, the investigators aim to implement a randomized controlled trial to assess
whether oral Babaodan adjuvant therapy can effectively prevent tumor recurrence after
curative resection for HCC patients, improve the quality of life, and evaluate the short-term
and long-term safety of this drug.
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