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

NCT06323382 | Recruiting DMC

• 1 other identifier: Liver Project 6
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Hepatocellular Carcinoma; Anti-PD1/PDL1 Antibody; Bevacizumab

Keywords

Bevacizumab; Atezolizumab; Tislelizumab; Toripalimab; Sintilimab; Camrelizumab

Outcome Measures

Primary Outcomes (1)

• Progression-Free-Survival (PFS)

  Progression was defined as progressive disease by independent radiologic review

  12 months

Secondary Outcomes (3)

• Overall survival (OS)

  24 months

• Objective response rate (ORR)

  12 months

• Adverse events

  24 months

Interventions

Locoregional therapy PROCEDURE

TACE procedure The decision to utilize transarterial artery chemoembolization (TACE) was performed through the tumor-feeding artery. The embolization emulsion was a mixture of Epirubicin 30-60 mg, Lobaplatin 30-50 mg, and Lipiodol 10-30 ml, and it was infused into tumor-feeding arteries via a 2.7/2.8 Fr micro-catheter. HAIC procedure Hepatic arterial infusion chemotherapy (HAIC) procedure was performed with FOLFOX regimen: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1400 mg/m2 leucovorin from hour 2 to 4 on day 1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg/m2 fluorouracil over 46 h on days 1 and 2.

Also known as: TACE/HAIC

Bevacizumab DRUG

15mg/kg or 7.5mg/kg intravenously every 3 weeks

Atezolizumab DRUG

1200mg intravenously every 3 weeks

Tislelizumab DRUG

200mg intravenously every 3 weeks

Toripalimab DRUG

220mg intravenously every 3 weeks

Sintilimab DRUG

200mg intravenously every 3 weeks

Camrelizumab DRUG

200mg intravenously every 3 weeks

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• HCC diagnosed by histopathological examination or Guidelines for Diagnosis and Treatment of Primary Liver Cancer or the recurrent HCC after surgery;
• age between 18 and 75 years;
• Stage B (middle stage) or C (late stage) HCC determined in accordance with Barcelona Clinic Liver Cancer staging system (BCLC stage).
• 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).
• Child-Pugh class A or B;
• Eastern Cooperative Group performance status (ECOG) score of 0-2;
• 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
• Prothrombin time ≤18s or international normalized ratio \< 1.7.
• Ability to understand the protocol and to agree to and sign a written informed consent document.

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Chinese PLA hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Interventions

Bevacizumab; atezolizumab; tislelizumab; toripalimab; sintilimab; camrelizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Feng duan, MD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qunfang Zhou, MD

CONTACT

86 19868000115; zhouqun988509@163.com

Feng Duan, MD

CONTACT

13910984586; duanfeng@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 21, 2024
• Study Start: January 1, 2021
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)