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

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.

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

Conditions4

Browse More Trials