Clinical Trials

Study Title

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination with either Durvalumab Monotherapy or Durvalumab plus Bevacizumab Therapy in Patients with Locoregional Hepatocellular Carcinoma

Purpose

To compare the efficacy of TACE with Duravalumab + Bevacizumab, TACE with Duravalumab alone and TACE only.

Eligibility

Age ≥18 years at the time of screening

Confirmed HCC based on histopathological findings from tumor tissue

No evidence of extrahepatic disease on baseline chest/abdomen/pelvis imaging

Disease not amenable to curative surgery or transplantation or curative ablation

Disease must be amenable to TACE

You Cannot

·         Have any clinically significant cardiovascular disease

·         Have a history of a stroke or myocardial infarction

·         Have had any kind of surgery in the past 28 days

·         Have uncontrolled hypertension

·         Have clinically meaningful ascites

·         Have a history of prior TACE, prior bland embolization, or prior radioembolization

·         Have received prior systemic anticancer therapy

·         Current or prior use of immunosuppressive medication within 14 days

Study Process

This study will be conducted in patients with locoregional HCC not amenable to curative therapy (eg, surgical resection, transplantation, or ablation).  Study will enroll 600 patients globally.

                    Arm A: Durvalumab +TACE then Durvalumab + bevacizumab placebo (every 3weeks)

            Arm B: Durvalumab  + TACE then Durvalumab + bevacizumab 15 mg/kg (every 3weeks)

            Arm C: Durvalumab +TACE then Durvalumab placebo + bevacizumab placebo (every 3weeks)