This is a prospective, open label, multi-center, interventional study to assess the safety and efficacy of Druvalumab plus Tremelimumab as first-line treatment in Chinese patients with unresectable hepatocellular carcinoma.
Based on the promising result of HIMALAYA and study 22, this study is going to evaluate the efficacy and safety of Durvalumab plus Tremelimumab in Chinese population and some extended population compared to HIMALAYA, such as Child-Pugh B and, ECOG PS2.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
214
Durvalumab IV (intravenous infusion)
Tremelimumab IV (intravenous infusion) CTLA-4 inhibitor
Research Site
Beijing, China
≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 1
Safety endpoint
Time frame: From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 44months
≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 2
Safety endpoint
Time frame: From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 44 months
Overall Survival (OS)
efficacy endpoint
Time frame: From the first dose of treatment to the date of death, regardless of the actual cause of the subject's death, assessed up to 44 months
Progression Free Survival (PFS) per RECIST v1.1/mRECIST
efficacy endpoint
Time frame: From first dose of treatment until progression per RECIST 1.1/ mRECIST as assessed by the Investigator or death due to any cause prior to progression, assessed up to 15 months
Objective Response Rate (ORR) per RECIST 1.1/ mRECIST
efficacy endpoint
Time frame: Until progression, assessed up to 15 months
Disease Control Rate (DCR) per RECIST 1.1/ mRECIST
efficacy endpoint
Time frame: Until progression, assessed up to 15 months
Duration of response (DoR) per RECIST 1.1/mRECIST
efficacy endpoint
Time frame: From the first dose, until progression, assessed up to 15 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Changsha, China
Research Site
Changsha, China
Research Site
Chengdu, China
Research Site
Fuzhou, China
Research Site
Guangzhou, China
Research Site
Guangzhou, China
...and 19 more locations