Hepatocellular Carcinoma Clinical Trial
Official title:
Liver Resection Versus Transarterial Chemoembolization for the Treatment of Intermediate-stage Hepatocellular Carcinoma: a Prospective Non-randomized Trial
The role of transarterial chemoembolization (TACE) as the standard therapy for
intermediate-stage hepatocellular carcinoma (HCC) is being challenged by increasing studies
which showed that liver resection (LR) is a safe and feasible procedure with better survival
outcomes than TACE does.
In light of this, the investigators have constructed a Markov model to simulate comparing LR
and TACE in the treatment of intermediate-stage HCC. The results suggested that LR may
provide survival benefit over TACE for the treatment of intermediate-stage HCC in cirrhotic
patients. However, validating the simulated result by a study with higher quality (e.g.
prospective clinical trial) would be of great value in providing a more convincing finding.
Therefore, based on the established Markov model, the investigators aimed to prospectively
compare the treatment efficacy and safety of LR with TACE for consecutive patients with
intermediate-stage HCC.
Hepatocellular carcinoma (HCC) is the 5th most common cancer worldwide and the third most
frequent cause of death of cancer. However, the management strategies for intermediate-stage
HCC remain controversial without global consensus. On one hand, Barcelona Clinic Liver
Cancer (BCLC) staging system recommends liver resection (LR) for very early and early-stage
HCC, and transarterial chemoembolization (TACE) for intermediate-stage HCC. On the other
hand, observational studies in both Eastern and Western countries have emerged to suggest
that LR was safe and achieved better survival than TACE for patients with intermediate-stage
HCC, but only very few studies have been conducted to directly compare LR with TACE for
these patients.
In light of this, the investigators have conducted a multistate Markov model simulating a
randomized clinical trial comparing LR with TACE over a follow-up period of 15 years. The
results suggested that LR may provide survival benefit over TACE for the treatment of
intermediate-stage HCC in cirrhotic patients. However, validating the simulated result by a
study with higher quality (e.g. prospective clinical trial) would be of great value in
providing a more convincing finding.Therefore, based on the established Markov model,the
investigators aimed to prospectively compare the treatment efficacy and safety of LR with
TACE for consecutive patients with intermediate-stage HCC.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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