Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma
Not Applicable
Not yet recruiting
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Registration Number
- NCT07081633
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is a Phase II, single-arm, multicentre study, assessing the efficacy and safety of durvalumab and tremelimumab with lenvatinib in participants with unresectable HCC.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 114
Inclusion Criteria
- Confirmed HCC based on histopathological findings from tumor tissues or radiologically findings.
- Must not have received prior systemic therapy for unresectable HCC.
- Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.
- Child-Pugh Score class A.
- ECOG performance status of 0 or 1 at enrollment.
- At least 1 measurable lesion per RECSIT 1.1 guidelines
Exclusion Criteria
- Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥2 from previous anticancer therapy.
- History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy.
- Clinically meaningful ascites.
- Patients with main portal vein thrombosis.
- Active or prior documented GI bleeding.
- Patient currently exhibits symptomatic or uncontrolled hypertension.
- Patients co-infected with HBV and HCV, or co-infected with HBV and hepatitis D virus (HDV)
- Uncontrolled intercurrent illness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm Durvalumab Durvalumab and Tremelimumab with Lenvatinib Single Arm Tremelimumab Durvalumab and Tremelimumab with Lenvatinib Single Arm Lenvatinib Durvalumab and Tremelimumab with Lenvatinib
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) per RECIST 1.1 From the date of first dose until the date of objective PD per RECIST 1.1 or death, whichever came first. It will be assessed when approximately 69 PFS events have occurred (60% maturity), approximately 8 months after the last patients dosed. Efficacy endpoint
- Secondary Outcome Measures
Name Time Method Grade ≥ 3 TRAE within 6 months after the initiation of study intervention From first dose to 6 months after the initiation of study intervention safety endpoint
Overall Survival (OS) From the date of the first dose of study intervention until death due to any cause. It will be assessed when approximately 69 OS events have occurred (60% maturity), approximately 24 months after last participant has been assigned to study intervention. Efficacy endpoint
Objective Response Rate (ORR) per RECIST 1.1 From the date of the first dose of study intervention until the date of objective PD per RECIST 1.1. It is anticipated that this analysis will be performed approximately 8 months after the last patient has been assigned to study intervention. Efficacy endpoint
Disease Control Rate (DCR) per RECIST 1.1 From the date of the first dose of study intervention until the date of objective PD per RECIST 1.1. It is anticipated that this analysis will be performed approximately 8 months after the last patient has been assigned to study intervention. Efficacy endpoint
Duration of response (DoR) per RECIST 1.1 From the date of response until the date of objective PD per RECIST 1.1 or death, whichever came first. It is anticipated that this analysis will be performed approximately 8 months after the last patient dosed. Efficacy endpoint
Progression Free Survival (PFS) per mRECIST From the date of the first dose until the date of objective PD per mRECIST or death, whichever came first. It will be assessed when approximately 69 PFS events have occurred (60% maturity), approximately 8 months after the last patients dosed. Efficacy endpoint
Trial Locations
- Locations (22)
Beijing Cancer Hospital
🇨🇳Beijing, China
China-japan Friendship Hospital
🇨🇳Beijing, China
Peking University People's Hospital
🇨🇳Beijing, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, China
Affiliated Cancer Hospital of Guangzhou Medical University
🇨🇳Guangzhou, China
Nanfang Hospital of Southern Medical University
🇨🇳Guangzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, China
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