Locoregional Therapy Combined With Bevacizumab and PD1/L1 Inhibitor in Advanced Hepatocellular Carcinoma

March 15, 2024 updated by: Zhou Qunfang, Sun Yat-sen University

Efficacy of Locoregional Therapy Combined With Bevacizumab and PD1/L1 Inhibitor in Advanced Hepatocellular Carcinoma: a Multicenter, Observational, Real-world Study

Atezolizumab + Bevacizumab was superior to sorafenib in overall survival in advanced hepatocellular carcinoma. The programmed cell death protein-1 (PD1) and PDL1 inhibitor, was effective and tolerable in patients with advanced hepatocellular carcinoma. We aimed to describe the efficacy and safety of locoregional therapy combined with Bevacizumab and PD1/L1 inhibitor in patients with advanced hepatocellular carcinoma who can not receive radical therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a multicenter, observational real-world study to explore the efficacy, safety of locoregional therapy combined with Bevacizumab and PD1/L1 inhibitor in advanced hepatocellular carcinoma. This study focused on the management of locoregional therapy combined with Bevacizumab and PD-1/L1 inhibitor. This study will create a database that will provide clinical parameters and outcomes of patients undergoing locoregional therapy combined Bevacizumab and PD-1/L1 inhibitor as standard of care in hopes of answering key clinical questions.

Study Type

Observational

Enrollment (Estimated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Feng Duan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

This study is a multicenter, observational real-world study to explore the efficacy, safety of locoregional therapy combined with Bevacizumab and PD1/L1 inhibitor in advanced hepatocellular carcinoma. This study focused on the management of locoregional therapy combined with Bevacizumab and PD-1/L1 inhibitor. This study will create a database that will provide clinical parameters and outcomes of patients undergoing locoregional therapy combined Bevacizumab and PD-1/L1 inhibitor as standard of care in hopes of answering key clinical questions.

Description

Inclusion Criteria:

  1. HCC diagnosed by histopathological examination or Guidelines for Diagnosis and Treatment of Primary Liver Cancer or the recurrent HCC after surgery;
  2. age between 18 and 75 years;
  3. Stage B (middle stage) or C (late stage) HCC determined in accordance with Barcelona Clinic Liver Cancer staging system (BCLC stage).
  4. Locoregional therapy include TACE or HAIC, locoregional combined with Bevacizumab and PD1/L1 inhibitor as firstline therapy; non-firstline therapy (previous use of any systemic therapy but intolerant or drug resistant).
  5. Child-Pugh class A or B;
  6. Eastern Cooperative Group performance status (ECOG) score of 0-2;
  7. Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
  8. Prothrombin time ≤18s or international normalized ratio < 1.7.
  9. Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion Criteria:

  1. Cholangiocellular carcinoma (ICC).
  2. Patients without image information should be excluded;
  3. The survival or patients less than 3 months.
  4. Serious medical comorbidities.
  5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy.
  6. Known history of HIV.
  7. History of organ allograft.
  8. Known or suspected allergy to the investigational agents or any agent given in association with this trial.
  9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  10. Evidence of bleeding diathesis.
  11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free-Survival (PFS)
Time Frame: 12 months
Progression was defined as progressive disease by independent radiologic review
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 24 months
OS is the length of time from the date of inclusion until death from any cause.
24 months
Objective response rate (ORR)
Time Frame: 12 months
ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response.
12 months
Adverse events
Time Frame: 24 months
Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Feng Duan, MD, Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Liver Project 6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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