This is a prospective, randomized, open-label, parallel-group, active controlled, multi-center phase III registration clinical study to observe, compare and evaluate the efficacy and safety of Toripalimab (hereafter referred to as JS001) combined with Bevacizumab versus Sorafenib as the first-line therapy for advanced HCC This study will enroll the patients with locally advanced or metastatic hepatocellular carcinoma who could not be radically cured and not receive any prior systemic therapy. The study will use PFS and OS as the co-primary endpoints, with approximately 280 patients planned to be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
326
Experimental group: Toripalimab, 240mg, IV infusion, every 3 weeks (q3w). combined with Bevacizumab 15mg/kg, IV infusion, every 3 weeks (q3w), Continuous infusion, in a cycle of 3 weeks (21 days), until occurrence of termination event specified in the protocol.
Control group: Sorafenib 400mg, po, Bid, continuous administration, until occurrence of termination event specified in the protocol.
The First Affiliated Hospital of Bengbu Medical college
Bengbu, Anhui, China
Anhui Cancer Hospital
Hefei, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Progression-free survival (PFS)
A duration from the date of initial treatment with Toripalimab Plus Bevacizumab or Sorafenib to disease progression (defined by RECIST 1.1) or death of any cause, whichever comes first.
Time frame: Up to 2 years
Overall survival (OS)
Duration from the date of initial treatment with Toripalimab Plus Bevacizumab or Sorafenib monotherapy to the date of death due to any cause.
Time frame: Up to 2 years
ORR
The rate of participants that achieve either a complete response (CR) or a partial response (PR).
Time frame: Up to 2 years
DoR
Duration from the first time reported partial response or complete response to the first time of disease progression or death.
Time frame: Up to 2 years
Disease Control Rate (DCR)
Proportion of patients with reduction and non-change in tumor burden of a predefined amount, including complete remission, partial remission and stable disease
Time frame: Up to 2 years
TTP
Define as the time from randomization to the first documented disease progression
Time frame: Up to 2 years
Incidence of AEs/SAEs as Assessed by CTCAE v5.0
Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0
Time frame: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years.
TMB
Correlation between tumor mutation burden (TMB) and the efficacy of Toripalimab combined with Bevacizumab
Time frame: Up to 12 years
ADA
Serum levels and incidence of Anti-drug antibody of Toripalimab combined with Bevacizumab treatment group
Time frame: Up to 12 years
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China PLA General Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Army Medical Center of PLA
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Southwest Hospital Of AMU
Chongqing, Chongqing Municipality, China
...and 46 more locations