Liver Resection Versus Transarterial Chemoembolization for the Treatment of Intermediate-stage Hepatocellular Carcinoma

• Status: Unknown status
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Antineoplastic Agents; Carboplatin; Cisplatin; Doxorubicin; Epirubicin; Ethiodized Oil; Fluorouracil; Gelatin Sponge, Absorbable; Liver Extracts; Pirarubicin

Criteria

Inclusion Criteria:

• age between 18 and 75 years

• 2 to 3 lesions with at least one >3 cm in diameter; or more than 3 lesions of any diameter

• Child-Pugh A/B liver function

• no previous treatment

• an Eastern Cooperative Oncology Group performance status of 0

Exclusion Criteria:

• radiologic or pathological evidence of vascular invasion or extrahepatic metastases

• severe coagulopathy (prothrombin activity <40% or a platelet count of<40,000/mm3)

• evidence of hepatic decompensation including refractory ascites, esophageal or gastric variceal bleeding, or hepatic encephalopathy

• obstructive jaundice

• an American Society of Anesthesiologists score of 3 or more

• present or past history of any other concurrent malignancies

• complicated with other severe diseases such as chronic kidney disease, cardiovascular disease, auto-immunological disease, etc

• contraindications to carboplatin, epirubicin, mitomycin, or lipiodol