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

Last updated: February 6, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Digestive System Neoplasms

Liver Cancer

Liver Disorders

Treatment

Tremelimumab

Durvalumab

Clinical Study ID

NCT05557838
D419CR00026
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Confirmed HCC based on histopathological findings from tumor tissue orradiologically 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 ECOGPS of 0-1 will be enrolled in cohort 1 and Child-Pugh Score class B or ECOG PS of 2will be enrolled in cohort 2)

  • At least 1 measurable lesion per RECSIT 1.1 guidelines

Exclusion

Exclusion Criteria:

  • Hepatic encephalopathy within past 12 months or requirement for medication toprevent 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

Study Design

Total Participants: 210
Treatment Group(s): 2
Primary Treatment: Tremelimumab
Phase: 3
Study Start date:
February 22, 2023
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • Research Site

    Beijing, 100142
    China

    Site Not Available

  • Research Site

    Changsha, 410005
    China

    Completed

  • Research Site

    Chengdu, 610041
    China

    Site Not Available

  • Research Site

    Fuzhou, 350011
    China

    Site Not Available

  • Research Site

    Guangzhou, 510100
    China

    Site Not Available

  • Research Site

    Hangzhou, 310022
    China

    Site Not Available

  • Research Site

    Harbin, 150081
    China

    Site Not Available

  • Research Site

    Ji Nan, 2501117
    China

    Active - Recruiting

  • Research Site

    Nanjing, 210029
    China

    Site Not Available

  • Research Site

    Ningbo, 315010
    China

    Site Not Available

  • Research Site

    Shanghai, 200040
    China

    Site Not Available

  • Research Site

    Shenyang, 110001
    China

    Site Not Available

  • Research Site

    Tianjin, 300170
    China

    Site Not Available

  • Research Site

    Wenzhou, 325000
    China

    Site Not Available

  • Research Site

    Wuhan, 430079
    China

    Site Not Available

  • Research Site

    Xi'an, 710038
    China

    Site Not Available

  • Research Site

    Zhangjiagang, 215699
    China

    Site Not Available

  • Research Site

    Zhengzhou, 450000
    China

    Site Not Available

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