NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma

NCT07081633

Active Not RecruitingPhase 2

Sponsor: AstraZeneca

Conditions: Hepatocellular Carcinoma

Interventions: Durvalumab, Tremelimumab, Lenvatinib

Countries: China, Hong Kong

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (23)

Beijing, China
Beijing, China
Beijing, China
Chengdu, China
Chongqing, China
Guangzhou, China
Guangzhou, China
Guangzhou, China
Guangzhou, China
Hangzhou, China
Hefei, China
Jinan, China
Nanjing, China
Nanjing, China
Ningbo, China
Shanghai, China
Shanghai, China
Tianjin, China
Wenzhou, China
Wuhan, China
Xiamen, China
Zhengzhou, China
New Territories, Hong Kong