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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
View:

• 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.

Locations
Other Locations
China
Chinese PLA hospital
RECRUITING
Beijing
Contact Information
Primary
Qunfang Zhou, MD
zhouqun988509@163.com
86 19868000115
Backup
Feng Duan, MD
duanfeng@vip.sina.com
13910984586
Time Frame
Start Date: 2021-01-01
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 240
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov