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

Recruiting now

Conditions studied: Advanced Hepatocellular Carcinoma, Anti-PD1/PDL1 Antibody, Bevacizumab

In brief

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.

Key facts

Study ID

NCT06323382

Run by

Sun Yat-sen University

People needed

240

Starts

2021-01-01

Expected to finish

2025-12-30

Last updated by the study team

2025-08-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Chinese PLA hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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