- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06244446
Efficacy and Safety of SBRT Combined With Atezolizumab Plus Bevacizumab vs Atezolizumab Plus Bevacizumab in Treating Unresectable Advance Hepatocellular Carcinoma.
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Dr Phool Chand, MD
- Phone Number: 01146300000
- Email: phoolchand99@gmail.com
Study Locations
-
-
Delhi
-
New Delhi, Delhi, India, 110070
- Institute of Liver & Biliary Sciences
-
Contact:
- Dr Phool Chand, MD
- Phone Number: 01146300000
- Email: phoolchand99@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age; 18-70 years.
- Unresectable advance HCC with PVTT
- At least one measurable (measurable according to Response Evaluation Criteria In Solid Tumors (mRECIST V.1.1)), untreated lesions.
- Patients with hepatitis B virus (HBV) infection: HBV-DNA <500 IU/mL obtained within 28 days before the start of study treatment and received anti-HBV treatment for at least 28 days before entering the study.
- Patients with hepatitis C virus (HCV) infection: HCV-DNA <500 IU/mL obtained within 28 days before the start of study treatment and received anti-HCV treatment for at least 28 days before entering the study.
- Maximum diameter of tumor ≤ 15cm
- Maximum number of tumor nodules ≤5
- Liver function: Child-Pugh class A, B7; normal liver volume is more than 800cm3.
- Karnofsky performance status ≥ 80%
- The expected survival of the patient is more than 6 months.
- Agree to accept post-procedure follow-up required by the design of this study.
The following conditions are met:
i. Platelet≥60×109/L; White blood cell≥3.0×109/L; Hemoglobin≥85 g/L; Serum creatinine≤1.4 × upper limit;. PT-INR ≤1.7
Exclusion Criteria:
- Patients with untreated or incompletely treated esophageal and/or gastric varices with associated bleeding or at high risk of bleeding.
- Coinfection with HBV and hepatitis C virus (HCV).
- Symptomatic, untreated or progressively progressive central nervous system (CNS) metastases.
- The patient cannot receive follow-up or is participating in other clinical trials.
- Subjects deemed unsuitable for inclusion in this study by the investigator.
- Current or past autoimmune disease or immunodeficiency.
- History of leptomeningitis.
- Idiopathic pulmonary fibrosis, organising pneumonia or evidence of active pneumonia on chest.
- Known active tuberculosis.
- Severe infection within 4 weeks prior to initiation of study treatment
A potential subject who meets any of the following criteria will be excluded from participation in this study:
i) Previous radiotherapy to the liver ii) Known current pregnancy iii) Loss of fat planes of tumor with organ at risk like the esophagus, stomach, duodenum, small bowel on CT or on MRI
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
SBRT+Atezolizumab+Bevacizumab
|
No intervention.
It is an observational study
|
Atezolizumab+Bevacizumab
|
No intervention.
It is an observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective response rate (ORR), which is defined as the proportion of patients with complete response (CR) and partial response (PR) at 6 months . CR or PR is assessed in accordance with mRECIST.
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 6 months.
|
6 months.
|
Overall survival
Time Frame: 12 months.
|
12 months.
|
Overall survival
Time Frame: 3 months.
|
3 months.
|
Disease control rate (DCR) at 3 months, defined as the percentage of subjects with the best response as CR, PR or stable disease (SD).
Time Frame: 3 months.
|
3 months.
|
Disease control rate (DCR) at 6 months, defined as the percentage of subjects with the best response as CR, PR or stable disease (SD).
Time Frame: 6 months.
|
6 months.
|
Disease control rate (DCR) at12 months, defined as the percentage of subjects with the best response as CR, PR or stable disease (SD).
Time Frame: 12 months.
|
12 months.
|
Progression-free survival (PFS)
Time Frame: 3 months.
|
3 months.
|
Progression-free survival (PFS)
Time Frame: 6 months.
|
6 months.
|
Progression-free survival (PFS)
Time Frame: 12 months.
|
12 months.
|
Adverse events
Time Frame: 3 months.
|
3 months.
|
Adverse events
Time Frame: 6 months.
|
6 months.
|
Adverse events
Time Frame: 12 months.
|
12 months.
|
Number of Participants with biomarkers change ( AFP , PIVKA II) in both groups.
Time Frame: 3 months.
|
3 months.
|
Number of Participants with biomarkers change ( AFP , PIVKA II) in both groups.
Time Frame: 6 months.
|
6 months.
|
Number of Participants with biomarkers change ( AFP , PIVKA II) in both groups.
Time Frame: 12 months.
|
12 months.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ILBS-HCC-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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