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

NCT06244446 | Unknown

• 1 other identifier: ILBS-HCC-07
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Advanced Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (15)

• Overall survival

  3 months.

• Overall survival

  6 months.

• Overall survival

  12 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).

  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).

  6 months.

Study Arms (2)

SBRT+Atezolizumab+Bevacizumab

Other: No intervention

Atezolizumab+Bevacizumab

Other: No intervention

Interventions

No intervention OTHER

No intervention. It is an observational study

Atezolizumab+Bevacizumab; SBRT+Atezolizumab+Bevacizumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HCC with PVTT (BCLC -C)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, stool, urine \& saliva

Central Study Contacts

Dr Phool Chand, MD

CONTACT

01146300000; phoolchand99@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: February 6, 2024
• Study Start: February 5, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 6, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)