SBRT + Atezolizumab + Bevacizumab in Resectable HCC
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|ClinicalTrials.gov Identifier: NCT04857684|
Recruitment Status : Not yet recruiting
First Posted : April 23, 2021
Last Update Posted : April 23, 2021
This study is evaluating the safety and tolerability of neoadjuvant stereotactic body radiation therapy (SBRT) with atezolizumab and bevacizumab for treating resectable hepatocellular carcinoma.
This study involves the following study interventions:
- Stereotactic Beam Radiation Therapy (SBRT)
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma Resectable Hepatocellular Carcinoma||Drug: Atezolizumab Drug: Bevacizumab Radiation: Stereotactic Beam Radiation Therapy (SBRT)||Early Phase 1|
This is a single-center, open-label, single-arm pilot study designed to evaluate the safety and tolerability of neoadjuvant radiation therapy plus atezolizumab and bevacizumab in patients with treatment-naïve resectable hepatocellular carcinoma.
This research study is a Pilot Study, which is the first-time investigators are examining this intervention of neoadjuvant radiation therapy plus atezolizumab and bevacizumab.
The U.S. Food and Drug Administration (FDA) has not approved atezolizumab, bevacizumab, stereotactic body radiation therapy (SBRT) for resectable hepatocellular carcinoma but they have been approved for other uses. Surgery is an accepted and standard treatment option for resectable hepatocellular carcinoma
The study interventions (atezolizumab bevacizumab, and SBRT) are thought to increase the immune system's (the system in the body that fights against disease) response to cancer cells. These interventions may increase the immune system's response by helping the T cells (an immune cell that identifies and attacks infected cells) recognize and find cancer cells in the body. By increasing the system's response, it is believed the chances of recurrence of resectable hepatocellular carcinoma will be less than when only standard of care surgery is used.
The research study procedures include screening for eligibility and study treatment, including evaluations and follow up visits.
Participants will receive study treatment for as long as they and their doctor believe they are benefitting from the study interventions and will be followed for 5 years or until participants withdraw their consent to be contacted.
It is expected that about 20 people will take part in this research study
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Neoadjuvant Stereotactic Beam Radiation Therapy Followed by Atezolizumab and Bevacizumab in Resectable Hepatocellular Carcinoma|
|Estimated Study Start Date :||August 2021|
|Estimated Primary Completion Date :||June 30, 2024|
|Estimated Study Completion Date :||December 1, 2025|
Experimental: Stereotactic beam radiation therapy (SBRT) +Atezolizumab + Bevacizumab
Other Name: Tecentriq
Other Name: Avastin
Radiation: Stereotactic Beam Radiation Therapy (SBRT)
External beam radiation
Other Name: Radiation Therapy
- Proportion of patients with grade 3-4 treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: From enrollment to end of treatment, up to 6 months ]Assessed by CTCAE v5.0
- Objective response rate (ORR) [ Time Frame: From enrollment to end of treatment, up to 3 months ]Assessed by RECIST 1.1
- Proportion of patients who proceed to surgery after neoadjuvant treatment. [ Time Frame: From enrollment to end of treatment, up to 3 months ]Estimated with 95% confidence intervals based on the exact binomial distribution.
- Proportion of patients who undergo a microscopic margin-negative (R0) resection [ Time Frame: From enrollment to end of treatment, up to 3 months ]Estimated with 95% confidence intervals based on the exact binomial distribution.
- Complete response (CR) [ Time Frame: From enrollment to end of treatment, up to 3 months ]Assessed by RECIST 1.1
- Overall survival (OS) [ Time Frame: From enrollment to end of treatment, up to 2 years ]Estimated by the Kaplan-Meier method
- Recurrence-free survival (RFS) after resection [ Time Frame: From enrollment to end of treatment, up to 2 years ]Estimated by the Kaplan-Meier method
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04857684
|Contact: Joseph W Franses, MD, PhDemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Contact: Joseph W Franses, MD, PHD 617-724-4000 firstname.lastname@example.org|
|Principal Investigator: Joseph W Franses, MD, PHD|
|Principal Investigator:||Joseph W Franses, MD, PhD||Massachusetts General Hospital|