Long-term outcome of novel combined surgical-injection treatment (COSIT) for large hepatocellular carcinoma: Stage 2A IDEAL prospective case series

Osama M Elsanousi, Murtada A Mohamed, Fatima H Salim, Elsadig A Adam, Shahinaz Bedri, Osama M Elsanousi, Murtada A Mohamed, Fatima H Salim, Elsadig A Adam, Shahinaz Bedri

Abstract

Background: Large hepatocellular carcinoma (HCC) treatment options have obvious limitations. Our trial comprises ipsilateral hepatic artery ligation and extrahepatic collaterals division (HALED, reinforced by percutaneous tumor injection controlling residual HCC arterial supply. We aimed to evaluate the long term safety and feasibility of the Combined Surgical and Injection of alcohol Treatment (COSIT) as a novel therapy for the large HCC.

Material and methods: Candidates' clinical data of the of this case series were prospectively and sequentially reported in accordance with stage 2a development IDEAL (Idea, Development, Exploration, Assessment and Long-term monitoring) recommendations. It included adult patients with HCC (diameter >5 cm) subjected to COSIT coming to our center during a five years' trial evaluating the long term outcome measures. Study ID (NCT03138044 ClinicalTrials.gov).

Results: Patients were 21, their mean age (±standard deviation) was 61·9 (±9·3) years. Eleven (52.4%) patients had tumors diameter >10 cm. 17 (80.9%) patients were advanced BCLC stage. Six modifications were made in this injection phase till it came to a stability. The mean alcohol volume was 72.0 mls. The mean follow-up duration was 16 months. The median overall survival duration was 14 months. The one, three and five years' survival was 71.4%, 23.8% and 4.8%, respectively. Grade 3/4 and 4 Common Toxicity Criteria for Adverse Effects (v4.03) were encountered in 10 (47.6%) and one (4.8%) patients, respectively.

Conclusion: This preliminary findings of COSIT can be a promising alternative treatment for patients having large HCC. Consequently, a multicenter stage 2b Exploration IDEAL trial is suggested.

Keywords: Carcinoma; Combined modality therapy; Ethanol; Hepatic artery; Hepatocellular.

Conflict of interest statement

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.None.

© 2021 The Authors.

Figures

Fig. 1
Fig. 1
Demonstrating the injection phase steps from tumor localization by ultrasound to demonstration of the vessels; to percutaneous injection and vascular ablation.
Fig. 2
Fig. 2
Sequential illustration of injection phase modifications and outcomes trendlines in 21 patients. Modifications sites are serially indicated by blue arrows. (For interpretation of the references to colour in this figure legend, the reader is referred to the Web version of this article.)
Fig. 3a
Fig. 3a
Survival time curve after injection phase in 21 patients.
Fig. 3b
Fig. 3b
Time to progression curve after injection phase in 21 patients.

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