Actively Recruiting
Efficacy of Locoregional Therapy Combined With Bevacizumab and PD1/L1 Inhibitor in Advanced Hepatocellular Carcinoma: A Multicenter Observational Real-World Study
Led by Sun Yat-sen University · Updated on 2025-08-14
240
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the effectiveness and safety of combining locoregional therapy with Bevacizumab and PD1/L1 inhibitors in patients with advanced hepatocellular carcinoma who cannot undergo radical therapy. This observational, real-world study aims to collect clinical data to help answer important questions about managing this treatment approach in advanced liver cancer. The study is sponsored by Sun Yat-sen University and focuses on patients with stage B or C hepatocellular carcinoma. The treatments studied include locoregional therapies such as transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) combined with intravenous Bevacizumab and various PD1/L1 inhibitors, including Atezolizumab, Tislelizumab, Toripalimab, Sintilimab, and Camrelizumab. Bevacizumab is given every three weeks at doses of 7.5 or 15 mg/kg, while PD1/L1 inhibitors are administered intravenously every three weeks at specified doses. This study gathers data from patients receiving these combined therapies as standard care. Participants will be monitored over time with assessments including progression-free survival at 12 months as the primary outcome. Secondary outcomes include overall survival, objective response rates, and adverse events up to 24 months. Clinical parameters, imaging, and laboratory tests are used to evaluate treatment effects and safety. This study will help provide real-world evidence on the management of advanced hepatocellular carcinoma using these combined therapies.
CONDITIONS
Brief Title
Locoregional Therapy Combined With Bevacizumab and PD1/L1 Inhibitor in Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed hepatocellular carcinoma by histopathology or clinical guidelines
- Age between 18 and 75 years
- Stage B or C hepatocellular carcinoma based on Barcelona Clinic Liver Cancer staging
- Receiving locoregional therapy (TACE or HAIC) combined with Bevacizumab and PD1/L1 inhibitor as first-line or non-first-line therapy
- Child-Pugh class A or B liver function
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate blood counts and organ function including hemoglobin ≥ 8.5 g/dL, total bilirubin ≤ 30 mmol/L, serum albumin ≥ 32 g/L, AST and ALT ≤ 5 times upper limit of normal, serum creatinine ≤ 1.5 times upper limit of normal, INR ≤ 1.5 or normal PT/APTT, absolute neutrophil count > 1500/mm³
- Prothrombin time ≤ 18 seconds or international normalized ratio < 1.7
- Able to understand and sign informed consent
You will not qualify if you...
- Cholangiocellular carcinoma (ICC)
- No available imaging information
- Life expectancy less than 3 months
- Serious medical comorbidities
- Evidence of liver decompensation such as ascites, gastrointestinal bleeding, or hepatic encephalopathy
- Known HIV infection
- History of organ transplantation
- Known or suspected allergy to study drugs or related agents
- Cardiac arrhythmias requiring treatment
- Bleeding disorders
- Clinically significant gastrointestinal bleeding within 30 days prior to study entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants who undergo routine locoregional therapy combined with Bevacizumab and PD1/L1 inhibitors are observed to collect clinical parameters and outcomes as part of standard care.
Visits every 3 weeks aligned with drug administration schedules
Trial Site Locations
Total: 1 location
1
Chinese PLA hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
Research Team
Q
Qunfang Zhou, MD
F
Feng Duan, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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