Evaluate the Safety and Efficacy of Toripalimab Combined With Bevacizumab Versus Sorafenib Therapy for HCC
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04723004|
Recruitment Status : Active, not recruiting
First Posted : January 25, 2021
Last Update Posted : June 23, 2022
|Condition or disease||Intervention/treatment||Phase|
|Advanced Hepatocellular Carcinoma (HCC)||Combination Product: Toripalimab combined with Bevacizumab Drug: Sorafenib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||326 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-label, Multi-center Phase III Clinical Study to Evaluate the Safety and Efficacy of Toripalimab (JS001) Combined With Bevacizumab Versus Sorafenib as First-line Therapy for Advanced Hepatocellular Carcinoma|
|Actual Study Start Date :||October 15, 2020|
|Estimated Primary Completion Date :||August 31, 2022|
|Estimated Study Completion Date :||December 31, 2024|
Active Comparator: Experimental group
Toripalimab combined with Bevacizumab
Combination Product: Toripalimab combined with Bevacizumab
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.
Active Comparator: Control group
Sorafenib 400mg, po, Bid, continuous administration, until occurrence of termination event specified in the protocol.
- Progression-free survival (PFS) [ Time Frame: Up to 2 years ]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.
- Overall survival (OS) [ Time Frame: Up to 2 years ]Duration from the date of initial treatment with Toripalimab Plus Bevacizumab or Sorafenib monotherapy to the date of death due to any cause.
- ORR [ Time Frame: Up to 2 years ]The rate of participants that achieve either a complete response (CR) or a partial response (PR).
- DoR [ Time Frame: Up to 2 years ]Duration from the first time reported partial response or complete response to the first time of disease progression or death.
- Disease Control Rate (DCR) [ Time Frame: Up to 2 years ]Proportion of patients with reduction and non-change in tumor burden of a predefined amount, including complete remission, partial remission and stable disease
- TTP [ Time Frame: Up to 2 years ]Define as the time from randomization to the first documented disease progression
- Incidence of AEs/SAEs as Assessed by CTCAE v5.0 [ Time Frame: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years. ]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
- TMB [ Time Frame: Up to 12 years ]Correlation between tumor mutation burden (TMB) and the efficacy of Toripalimab combined with Bevacizumab
- ADA [ Time Frame: Up to 12 years ]Serum levels and incidence of Anti-drug antibody of Toripalimab combined with Bevacizumab treatment group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04723004