This is a single-arm clinical trial. The main objective is to determine the efficacy of
atezolizumab+bevacizumab therapy in patients with advanced hepatocellular carcinoma and with
chronic hepatitis B virus infection. All eligible patients will receive atezolizumab +
Combination of atezolizumab, an immune checkpoint inhibitors (ICI), and bevacizumab, an
anti-angiogenic antibody, has shown promising anti-tumor activity and good safety profile in
patients with advanced hepatocellular carcinoma (HCC) and good liver function reserves
(Child-Pugh class A). Currently all trials of ICI-based therapy for HCC enrolled only
patients with very low HBV viral loads if they had chronic HBV infection because of the
concern of the risk of HBV reactivation on the severity and management of liver-related
adverse events, particularly immune-related hepatitis.
The investigators hypothesize that in patients with advanced HCC, chronic HBV infection, and
adequate liver function reserves, the safety profile of ICI-based therapy should be similar
to those in other patient populations as long as prophylactic anti-HBV treatment is given,
regardless the baseline HBV viral load. This is because in patients with patients with
lymphoma and chronic HBV infection, who have the highest risk of HBV reactivation after
cytotoxic or immunosuppressive therapy, no HBV-related complications of clinical significance
were noted as long as prophylactic anti-HBV treatment started before the administration of
cytotoxic or immunosuppressive therapy.
This is a single-arm clinical trial. Key eligibility criteria will include the following:
histologically proven, locally advanced or metastatic and/or unresectable HCC that is not
amenable to curative surgical and/or locoregional therapies; no prior systemic therapy for
HCC; documented chronic HBV infection with HBV DNA > 2000 IU/mL obtained within 28 days prior
to initiation of study treatment; at least one measurable (per RECIST 1.1) lesion; ECOG
Performance Status of 0 or 1; and Child-Pugh class A.
All eligible patients will receive atezolizumab 1200 mg IV plus bevacizumab 15 mg/kg IV on
day 1 every 3 weeks. Study treatment will continue until documented tumor progression or
occurrence of unacceptable toxicity. All eligible subjects will receive anti-HBV treatment
(per local standard of care; e.g., entecavir) prior to start of study treatment and continue
anti-HBV treatment for the length of the study. The primary endpoint is overall response rate
defined as a complete or partial response, as determined by the investigator according to
RECIST v1.1. The secondary endpoints will include safety measures (e.g., the proportion of
subjects with grade 3 liver-related adverse events (AE) (according to NCI CTCAE v5.0),
incidence and severity of all adverse events/ immune-related adverse events, incidence of HBV
reactivation/ HBV-related hepatitis flare) and efficacy measures (e.g., objective response
rate, progression-free survival, duration of response, and overall survival). This study plan
to enroll 48 evaluable subjects, defined as subjects who receive 3 cycles of study treatment
and the first image evaluation for tumor response. The estimated time of enrollment will be 2
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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