Efficacy and Safety of SBRT Combined With Atezolizumab Plus Bevacizumab vs Atezolizumab Plus Bevacizumab in Treating Unresectable Advance Hepatocellular Carcinoma.

Advanced Hepatocellular Carcinoma Clinical Trial

Official title: Efficacy and Safety of SBRT Combined With Atezolizumab Plus Bevacizumab vs Atezolizumab Plus Bevacizumab in Treating Unresectable Advance Hepatocellular Carcinoma (SAB - A Prospective Observational Study).

Status Not yet recruiting

Clinical Trial Summary

SBRT, atezolizumab, and bevacizumab have different mechanisms of action and can potentially have synergistic effects when combined. SBRT delivers targeted radiation to the tumor, while atezolizumab enhances the immune response, and bevacizumab inhibits angiogenesis. The combination of SBRT with atezolizumab and bevacizumab will result in improved tumor response rates as compared to atezolizumab and bevacizumab alone in patients with advance unresectable hepatocellular carcinoma (HCC). Up until now, no study has been done that has compared SBRT with atezolizumab, and bevacizumab in unresectable advance hepatocellular carcinoma. With this study, investigator aim to study to compare the efficacy and safety of SBRT combined with atezolizumab and bevacizumab versus atezolizumab and bevacizumab alone in the treatment of unresectable advance hepatocellular carcinoma (HCC).

Clinical Trial Description

Hypothesis: The combination of SBRT with atezolizumab and bevacizumab will result in improved tumor response rates as compared to atezolizumab and bevacizumab alone in patients with advance unresectable hepatocellular carcinoma (HCC).

AIM:- The aim of this study is to compare the efficacy and safety of SBRT combined with atezolizumab and bevacizumab versus atezolizumab and bevacizumab alone in the treatment of unresectable advance hepatocellular carcinoma (HCC).

Study design:

• A prospective observational study.

• Single Centre.

• Open label.

• The study will be conducted in Department of Hepatology, ILBS. Study period: 1 years after ethical approval.

Sample size:

• Assuming that objective response rate with immunotherapy is 30%, further adding SBRT along with immunotherapy is increased by 50% that is objective response rate by adding SBRT is 80% .

• With ⍺-5 and power 80%, investigator need to enroll 36 cases and further adding 10% dropout rate investigator need to enroll 40 cases i.e. 20 in each group.

Monitoring and assessment: All the parameters of the objective and also noted any adverse effects.

Intervention: Nil

STATISTICAL ANALYSIS:

The continuous data will be represented as mean +/- SD or median (IQR). The categorical data will be represented as median (IQR).The comparison of continuous data will be done by using either Student's t test or Mann -Whitney test as appropriate. The Kaplan Meier and Cox regression will be used for survival analysis. Besides this an appropriate analysis will be done at the time of data analysis. P value < 0.05 will be considered as significant. ;

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular

• NCT number: NCT06244446
• Study type: Observational
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Phool Chand, MD
• Phone: 01146300000
• Email: phoolchand99@gmail.com
• Status: Not yet recruiting
• Start date: February 5, 2024
• Completion date: January 31, 2025