scholarly journals Randomized clinical trial of chemoembolization plus radiofrequency ablationversuspartial hepatectomy for hepatocellular carcinoma within the Milan criteria

2016 ◽  
Vol 103 (4) ◽  
pp. 348-356 ◽  
Author(s):  
H. Liu ◽  
Z.-G. Wang ◽  
S.-Y. Fu ◽  
A.-J. Li ◽  
Z.-Y. Pan ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Milan Criteria

Randomized clinical trial of transcatheter arterial chemoembolization plus radiofrequency ablation versus transcatheter arterial chemoembolization for hepatocellular carcinoma with intermediate stage (BCLC stage B) hepatocellular carcinoma beyond Milan criteria.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4077-4077
Author(s):  
Xin Yin ◽  
Bei Tang ◽  
Yu-Hong Gan ◽  
Yan-hong Wang ◽  
Yi Chen ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Clinical Trial ◽  
Overall Survival ◽  
Radiofrequency Ablation ◽  
Randomized Clinical Trial ◽  
Transcatheter Arterial Chemoembolization ◽  
Intermediate Stage ◽  
Milan Criteria ◽  
Tace Group ◽  
Arterial Chemoembolization

4077 Background: To determine treatment efficacy and safety of transarterial chemoembolization (TACE) combined with radiofrequency ablation (RFA) (hereafter, TACE+RFA) in patients with intermediate stage (BCLC stage B) hepatocellular carcinoma (HCC) beyond Milan criteria. Methods: In this randomized clinical trial, 110 patients with intermediate stage HCC beyond Milan criteria (single tumor with diameter 5-7cm, median; 3-5 multiple nodules with diameter less than 5cm) were included and randomly assigned to TACE+RFA group (n=55) and TACE group (n=55) at liver cancer institute, Zhongshan hospital. The primary endpoint was overall survival (OS). The secondary end point was progression-free survival (PFS) , time to progress (TTP) and best objective response (BOR). Results: The median OS in TACE+RFA and TACE group were 29 and 18 months, respectively. The median TTP and BOR were 15.7 months and 69.1 % in TACE+RFA group and 12.4 months and 40.0 % in TACE group (P=0.004). The 1-, 3-, and 4-year overall survivals for TACE+RFA group and TACE group were 97.2%, 67.9% and 59.4% versus 84.0%, 46.7% and 37.3% , respectively (P = 0.008). The corresponding PFS were 47.3%, 27.2% and 21.7% versus 35.6%,15.3% and 11.4% , respectively (P = 0.04).The incidences of major complications in TACE+RFA group were comparable to those in TACE group (P=0.14). Conclusions: TACE+RFA was superior to TACE in improving tumor response and overall survival for patients with intermediate stage (BCLC stage B) hepatocellular carcinoma beyond Milan criteria. Clinical trial information: NCT03636620.

Neoadjuvant transarterial infusion chemotherapy with FOLFOX could improve outcomes of resectable BCLC stage A/B hepatocellular carcinoma patients beyond Milan criteria: An interim analysis of a multi-center, phase 3, randomized, controlled clinical trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4008-4008
Author(s):  
Shaohua Li ◽  
Chong Zhong ◽  
Qiang Li ◽  
Jingwen Zou ◽  
Qiaoxuan Wang ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Clinical Trial ◽  
Adverse Events ◽  
Milan Criteria ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Free Survival ◽  
Infusion Chemotherapy ◽  
Transarterial Infusion

4008 Background: The efficacy of operation, as the only radical option for resectable BCLC stage A/B hepatocellular carcinoma (HCC) patients beyond Milan criteria, is still unsatisfactory. This study aimed to investigate to efficacy and safety of preoperative neoadjuvant transarterial infusion chemotherapy (TAI) with FOLFOX regimen for these patients. Methods: In this multi-center, prospective, phase 3, randomized, open-labeled, controlled clinical trial, resectable BCLC stage A/B HCC patients beyond Milan criteria were randomly assigned (1:1) before hepatectomy to receive either neoadjuvant TAI (NT group) or operation directly without any neoadjuvant treatment (OP group). The primary endpoint was overall survival (OS), the secondary endpoints are progression-free survival (PFS), recurrence free survival (RFS), and safety. Results: Between March, 2016 and July, 2020, 208 patients enrolled from five Chinese hospitals were randomly assigned to NT group (n=104) or OP group (n=104)， with 99 patients in NT group and 100 patients in OP group included in the efficacy and safety analysis. Clinicopathological characteristics were balanced between the two groups. The 1-, 2-, and 3-year OS rates for NT group were 92.9%, 78.6%, and 63.5%, and were 79.5%, 62.0%, and 46.3% for OP group, respectively. The 6-, 12-, and 18-month PFS rates for NT group were 77.6%, 50.4%, and 47.4%, and were 52.7%, 42.8%, and 34.8% for OP group, respectively. The OS and PFS were significantly better in NT group than in OP group (p=0.016 and 0.017, respectively). The 6-, 12-, and 18-month RFS rates for NT group were 63.8%, 47.3%, and 47.3%, and were 52.7%, 42.8%, and 34.8% for OP group, respectively. The RFS between the two group had no difference (p=0.385). No patients in NT group experienced grade 3 or more severe TAI related adverse events. The operation related adverse events were similar between two groups (p=0.300). Conclusions: Neoadjuvant TAI before hepatectomy may bring survival benefits for resectable BCLC stage A/B HCC patients beyond Milan criteria. Trial number: NCT03851913. Clinical trial information: NCT03851913.

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