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

AstraZeneca

Status and phase: Enrolling; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Durvalumab; Drug: Tremelimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05557838

D419CR00026

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

cohort 1

Experimental group

Description:

durvalumab in combination with tremelimumab

Treatment:

Drug: Tremelimumab

Drug: Durvalumab

cohort 2

Experimental group

Description:

durvalumab in combination with tremelimumab

Treatment:

Drug: Tremelimumab

Drug: Durvalumab