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Clinical Trials in China / NCT06323382
Recruiting Observational

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

NCT06323382 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Observational
Started
2021-01-01
Last updated
2025-08-14

Condition(s) studied

Advanced Hepatocellular CarcinomaAnti-PD1/PDL1 AntibodyBevacizumab

Investigational drug(s) / intervention(s)

Locoregional therapyBevacizumab →Atezolizumab →Tislelizumab →Toripalimab →Sintilimab →Camrelizumab →

Locoregional therapy: 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.

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

Atezolizumab: 1200mg intravenously every 3 weeks

Tislelizumab: 200mg intravenously every 3 weeks

Toripalimab: 220mg intravenously every 3 weeks

Sintilimab: 200mg intravenously every 3 weeks

Camrelizumab: 200mg intravenously every 3 weeks

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Progression-Free-Survival (PFS) — 12 months
    Progression was defined as progressive disease by independent radiologic review

Trial sites (1)

FacilityCityRegionStatus
Chinese PLA hospital Beijing Beijing Municipality Recruiting

On this site

📄 Avastin (bevacizumab) drug profile → 📄 Tecentriq (atezolizumab) drug profile →

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Other trials for the same condition

A Clinical Trial Evaluating the Safety and Efficacy of Intravenous CD-801 in Treating Advanced HCC Patients Recruiting
dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Hepatocellular Carcinoma Recruiting
A Study of BL-B01D1 Monotherapy, BL-B01D1 in Combination With Lenvatinib, BL-B01D1 in Combination With PD-1 Monoclonal Antibody, and BL-B01D1 in Combination With PD-1 Monoclonal Antibody and Bevacizumab in Patients With Advanced Hepatocellular Carcinoma Recruiting
Ablation of Oligometastasis Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma Recruiting
A Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06323382 on ClinicalTrials.gov ↗ ← All trials in China