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Summary

for people ages 18–100 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. The patients cannot be eligible for locoregional therapy.

Official Title

A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma

Details

The study population includes patients 18 years of age or older with unresectable HCC, Barcelona Clinic Liver Cancer stage B not eligible for locoregional therapy or stage C, and Child-Pugh A classification liver disease. Patients must not have received any prior systemic therapy for unresectable HCC.

Patients in all treatment arms may continue receiving their originally assigned treatment, at the Investigator's discretion, after the first overall time point assessment of progressive disease (PD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

Patients in all arms with confirmed PD who, in the Investigator's opinion, continue to receive benefit from their assigned treatment and meet the criteria for treatment in the setting of PD may continue to receive their assigned treatment.

If a patient discontinues study drug(s) due to disease progression, the patient will enter survival follow-up. Patients who have discontinued treatment due to toxicity or symptomatic deterioration or who have commenced subsequent anticancer therapy, will have tumor assessments until confirmed PD and will be followed for survival.

Keywords

Hepatocellular Carcinoma Hepatocellular Carcinoma Non-Resectable Carcinoma Carcinoma, Hepatocellular Sorafenib Tremelimumab Antibodies, Monoclonal

Eligibility

You can join if…

Open to people ages 18–100

  • HCC (unresectable hepatocellular carcinoma) histopathological diagnosis confirmation based on tumor tissue
  • No prior systemic therapy for 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

You CAN'T join if...

  • Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy
  • Ascites that requires ongoing paracentesis to control symptoms (within 6 weeks prior to the first scheduled dose)
  • Main portal vein thrombosis
  • Active or prior documented GI variceal bleed or history of upper GI bleeding, ulcers or esophageal varices with bleeding within 12 months
  • HBV and HCV co-infection

Locations

  • Research Site not yet accepting patients
    San Francisco, California, 94143, United States
  • Research Site not yet accepting patients
    Los Angeles, California, 900048, United States
  • Research Site not yet accepting patients
    Los Angeles, California, 90033, United States
  • Research Site withdrawn
    Orange, California, 92868, United States
  • Research Site not yet accepting patients
    Orange, California, 92868, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT03298451
Phase
Phase 3
Study Type
Interventional
Last Updated
November 14, 2017
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