Combining locoregional therapy with Bevacizumab and PD1/L1 inhibitors for advanced liver cancer

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

This study is testing if combining a local treatment with Bevacizumab and PD1/L1 inhibitors can help people with advanced liver cancer who can’t have surgery feel better and improve their outcomes.

Quick facts

• Study type: Observational
• Enrollment: 240 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: Bevacizumab, Atezolizumab
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06323382 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the efficacy and safety of locoregional therapy combined with Bevacizumab and PD1/L1 inhibitors in patients with advanced hepatocellular carcinoma (HCC) who are not candidates for radical therapy. It will create a comprehensive database to track clinical parameters and outcomes of patients receiving this combination treatment. The study focuses on patients diagnosed with HCC at various stages and aims to provide insights into the management of this condition using a real-world approach.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with advanced HCC who are not suitable for radical therapy and have a Child-Pugh class A or B.

Not a fit: Patients with early-stage HCC or those who have already received radical therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and survival rates for patients with advanced hepatocellular carcinoma.

How similar studies have performed: Previous studies have shown that combinations of Bevacizumab and PD1/L1 inhibitors can be effective in treating advanced HCC, suggesting a promising approach.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

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

Study contacts

• Principal investigator: Feng duan, MD — Chinese PLA General Hospital
• Study coordinator: Qunfang Zhou, MD

Conditions Advanced Hepatocellular Carcinoma; Anti-PD1/PDL1 Antibody; Bevacizumab; Atezolizumab; Tislelizumab; Toripalimab; Sintilimab; Camrelizumab