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Advanced Hepatocellular CarcinomaNCT06244446

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

An observational study of Advanced Hepatocellular Carcinoma, run by Institute of Liver and Biliary Sciences, India at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Hepatocellular Carcinoma
How many people
40 participants
Where
1 siteIndia
Study dates
5 Feb 2024to 31 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: HCC with PVTT (BCLC -C)

Who may be able to join

  • 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
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  • 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:
  • 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

Who cannot join

  • 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.
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  • 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:
  • 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

Trial locations and contacts

1 site in 1 country.

Dr Phool Chand, MD contact

01146300000

phoolchand99@gmail.com

India1 site

  • Institute of Liver & Biliary Sciences

    New Delhi, National Capital Territory of Delhi, 110070

    Dr Phool Chand, MD, 01146300000, phoolchand99@gmail.com

Other trials in India

About this study

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).

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).

Read the 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.

Being tested
No intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    No intervention. It is an observational study

Study groups in NCT06244446
Study groupRoleWhat they receive
SBRT+Atezolizumab+BevacizumabNot described
Receives: Other: No intervention
Atezolizumab+BevacizumabNot described
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

Secondary outcomes (15)

  1. Overall survival

    Measured: 3 months.

  2. Overall survival

    Measured: 6 months.

  3. Overall survival

    Measured: 12 months.

  4. Disease control rate (DCR) at 3 months, defined as the percentage of subjects with the best response as CR, PR or stable disease (SD).

    Measured: 3 months.

  5. Disease control rate (DCR) at 6 months, defined as the percentage of subjects with the best response as CR, PR or stable disease (SD).

    Measured: 6 months.

  6. Disease control rate (DCR) at12 months, defined as the percentage of subjects with the best response as CR, PR or stable disease (SD).

    Measured: 12 months.

  7. Progression-free survival (PFS)

    Measured: 3 months.

  8. Progression-free survival (PFS)

    Measured: 6 months.

  9. Progression-free survival (PFS)

    Measured: 12 months.

  10. Adverse events

    Measured: 3 months.

  11. Adverse events

    Measured: 6 months.

  12. Adverse events

    Measured: 12 months.

  13. Number of Participants with biomarkers change ( AFP , PIVKA II) in both groups.

    Measured: 3 months.

  14. Number of Participants with biomarkers change ( AFP , PIVKA II) in both groups.

    Measured: 6 months.

  15. Number of Participants with biomarkers change ( AFP , PIVKA II) in both groups.

    Measured: 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2024
  2. Study start5 Feb 2024 (estimated)
  3. Primary completion31 Jan 2025 (estimated)
  4. Study completion31 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06244446
Sponsor's protocol ID
ILBS-HCC-07
Status last verified
Jan 2024
First submitted
10 Jan 2024
Last updated
6 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Advanced Hepatocellular Carcinoma, run by Institute of Liver and Biliary Sciences, India at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dr Phool Chand, MD (01146300000, phoolchand99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06244446.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.

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