Trial Title:
Study of Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With Unresectable Hepatocellular Carinoma
NCT ID:
NCT05557838
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Durvalumab
Tremelimumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Durvalumab
Description:
Durvalumab IV (intravenous infusion)
Arm group label:
cohort 1
Arm group label:
cohort 2
Other name:
MEDI4736
Intervention type:
Drug
Intervention name:
Tremelimumab
Description:
Tremelimumab IV (intravenous infusion)
Arm group label:
cohort 1
Arm group label:
cohort 2
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
211405
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
CN-100730
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Changsha
Zip:
410005
Country:
China
Status:
Completed
Facility:
Name:
Research Site
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Fuzhou
Zip:
350011
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Guangzhou
Zip:
510100
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Guangzhou
Zip:
510260
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ji Nan
Zip:
2501117
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nanjing
Zip:
2100008
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Nanjing
Zip:
210009
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ningbo
Zip:
315010
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Shanghai
Zip:
200040
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Shenyang
Zip:
110001
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Tianjin
Zip:
300000
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Tianjin
Zip:
300170
Country:
China
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Wenzhou
Zip:
325000
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Xi'an
Zip:
710038
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Zhangjiagang
Zip:
215699
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Status:
Active, not recruiting
Start date:
June 26, 2023
Completion date:
March 31, 2025
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05557838
