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

Phase 3

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Durvalumab; Drug: Tremelimumab

• Registration Number: NCT05557838
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-28
• Study Start: 2023-02-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cohort 1	Tremelimumab	durvalumab in combination with tremelimumab
cohort 2	Tremelimumab	durvalumab in combination with tremelimumab
cohort 2	Durvalumab	durvalumab in combination with tremelimumab
cohort 1	Durvalumab	durvalumab in combination with tremelimumab

Primary Outcome Measures

Name	Time	Method
≥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 Outcome Measures

Name	Time	Method
≥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
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
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
Objective Response Rate (ORR) per RECIST 1.1/ mRECIST	Until progression, assessed up to 15 months
Disease Control Rate (DCR) per RECIST 1.1/ mRECIST	Until progression, assessed up to 15 months
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
Duration of response (DoR) per RECIST 1.1/mRECIST	From the first dose, until progression, assessed up to 15 months

Trial Locations

Locations (1)

Research Site; 🇨🇳 Zhengzhou, China