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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
Durvalumab IV (intravenous infusion)
Tremelimumab IV (intravenous infusion)
≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 1
Time frame: From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 29 months
≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 2
Time frame: From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 29 months
Overall Survival (OS)
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 29 months
Progression Free Survival (PFS) per RECIST v1.1/mRECIST
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
Time frame: Until progression, assessed up to 15 months
Disease Control Rate (DCR) per RECIST 1.1/ mRECIST
Time frame: Until progression, assessed up to 15 months
Rate of Adverse Events
Time frame: From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 29 months
Duration of response (DoR) per RECIST 1.1/mRECIST
Time frame: From the first dose, until progression, assessed up to 15 months
AstraZeneca Clinical Study Information Center
CONTACT
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Research Site
Beijing, China
ACTIVE_NOT_RECRUITINGResearch Site
Beijing, China
ACTIVE_NOT_RECRUITINGResearch Site
Beijing, China
ACTIVE_NOT_RECRUITINGResearch Site
Beijing, China
ACTIVE_NOT_RECRUITINGResearch Site
Changsha, China
COMPLETEDResearch Site
Changsha, China
ACTIVE_NOT_RECRUITINGResearch Site
Chengdu, China
ACTIVE_NOT_RECRUITINGResearch Site
Fuzhou, China
ACTIVE_NOT_RECRUITINGResearch Site
Guangzhou, China
ACTIVE_NOT_RECRUITINGResearch Site
Guangzhou, China
ACTIVE_NOT_RECRUITING...and 22 more locations