Study of Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With Unresectable Hepatocellular Carinoma

Hepatocellular Carcinoma Clinical Trial

— TREMENDOUS  

Official title:

An Open-label, Multi-center Phase IIIb Study of Durvalumab and Tremelimumab as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05557838
• Other study ID #: D419CR00026
• Status: Recruiting
• Phase: Phase 3
• Start date: February 22, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Durvalumab
Durvalumab IV (intravenous infusion)
• Tremelimumab
Tremelimumab IV (intravenous infusion)

Locations

Country	Name	City	State
China	Research Site	Beijing
China	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	Research Site	Guangzhou
China	Research Site	Guangzhou
China	Research Site	Hangzhou
China	Research Site	Harbin
China	Research Site	Ji Nan
China	Research Site	Nanjing
China	Research Site	Nanjing
China	Research Site	Nanjing
China	Research Site	Ningbo
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shenyang
China	Research Site	Tianjin
China	Research Site	Tianjin
China	Research Site	Tianjin
China	Research Site	Wenzhou
China	Research Site	Wuhan
China	Research Site	Wuhan
China	Research Site	Xi'an
China	Research Site	Zhangjiagang
China	Research Site	Zhengzhou
China	Research Site	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	=Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 1		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	=Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 2		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	Overall Survival (OS)		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
Secondary	Progression Free Survival (PFS) per RECIST v1.1/mRECIST		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
Secondary	Objective Response Rate (ORR) per RECIST 1.1/ mRECIST		Until progression, assessed up to 15 months
Secondary	Disease Control Rate (DCR) per RECIST 1.1/ mRECIST		Until progression, assessed up to 15 months
Secondary	Rate of Adverse Events		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	Duration of response (DoR) per RECIST 1.1/mRECIST		From the first dose, until progression, assessed up to 15 months