Clinical trial NCT05557838: Study of Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With Unresectable Hepatocellular Carinoma
Official title: An Open-label, Multi-center Phase IIIb Study of Durvalumab and Tremelimumab as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-09-28
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Confirmed HCC based on histopathological findings from tumor tissue or radiologically findings
* No prior systemic therapy for HCC
* Barcelona Clinic Liver Cancer (BCLC) stage B (not eligible for locoregional therapy) or stage C
* Child-Pugh Score class A or B
* ECOG performance status (PS) of 0-2 at enrollment (Child-Pugh Score class A and ECOG PS of 0-1 will be enrolled in cohort 1 and Child-Pugh Score class B or ECOG PS of 2 will be enrolled in cohort 2)
* At least 1 measurable lesion per RECSIT 1.1 guidelines

Exclusion Criteria:

* Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy
* Clinically meaningful ascites
* Main portal vein tumor thrombosis
* Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 6 months
* HBV and HVC co-infection, or HBV and Hep D co-infection

Primary outcomes:
measure: ≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 1
timeFrame: From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 29 months
Secondary outcomes:
measure: ≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 2
timeFrame: From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 29 months
measure: Overall Survival (OS)
timeFrame: 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
measure: Progression Free Survival (PFS) per RECIST v1.1/mRECIST
timeFrame: 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
measure: Objective Response Rate (ORR) per RECIST 1.1/ mRECIST
timeFrame: Until progression, assessed up to 15 months
measure: Disease Control Rate (DCR) per RECIST 1.1/ mRECIST
timeFrame: Until progression, assessed up to 15 months
measure: Rate of Adverse Events
timeFrame: From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 29 months
measure: Duration of response (DoR) per RECIST 1.1/mRECIST
timeFrame: From the first dose, until progression, assessed up to 15 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Fuzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Harbin
country: China
facility: Research Site
city: Ji Nan
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Ningbo
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Wenzhou
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Xi'an
country: China
facility: Research Site
city: Zhangjiagang
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
Study officials:
References: