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NCT05557838 | Recruiting | Hepatocellular Carcinoma


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

AstraZeneca

Brief 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.

Condition or disease

Hepatocellular Carcinoma

Intervention/treatment

Durvalumab

Tremelimumab

Phase

Phase 3

Study Type : Interventional
Estimated Enrollment : 210 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center Phase IIIb Study of Durvalumab and Tremelimumab as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma
Actual Study Start Date : February 22, 2023
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025
Arm Intervention/treatment

Experimental: cohort 1

durvalumab in combination with tremelimumab

Drug: Durvalumab

Drug: Tremelimumab

Experimental: cohort 2

durvalumab in combination with tremelimumab

Drug: Durvalumab

Drug: Tremelimumab

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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

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

Location Details


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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

China,

Research Site

Beijing, China, 100021

Active, not recruiting

China,

Research Site

Beijing, China, 100142

Recruiting

China,

Research Site

Beijing, China, 211405

Recruiting

China,

Research Site

Beijing, China, CN-100730

Completed

China,

Research Site

Changsha, China, 410005

Recruiting

China,

Research Site

Changsha, China, 410013

Active, not recruiting

China,

Research Site

Chengdu, China, 610041

Recruiting

China,

Research Site

Fuzhou, China, 350011

Recruiting

China,

Research Site

Guangzhou, China, 510060

Active, not recruiting

China,

Research Site

Guangzhou, China, 510100

Recruiting

China,

Research Site

Guangzhou, China, 510260

Recruiting

China,

Research Site

Guangzhou, China, 510515

Recruiting

China,

Research Site

Hangzhou, China, 310022

Recruiting

China,

Research Site

Harbin, China, 150081

Recruiting

China,

Research Site

Ji Nan, China, 2501117

Recruiting

China,

Research Site

Nanjing, China, 2100008

Recruiting

China,

Research Site

Nanjing, China, 210009

Recruiting

China,

Research Site

Nanjing, China, 210029

Recruiting

China,

Research Site

Ningbo, China, 315010

Recruiting

China,

Research Site

Shanghai, China, 200032

Active, not recruiting

China,

Research Site

Shanghai, China, 200040

Active, not recruiting

China,

Research Site

Shenyang, China, 110001

Active, not recruiting

China,

Research Site

Tianjin, China, 300000

Withdrawn

China,

Research Site

Tianjin, China, 300060

Withdrawn

China,

Research Site

Tianjin, China, 300170

Recruiting

China,

Research Site

Wenzhou, China, 325000

Recruiting

China,

Research Site

Wuhan, China, 430022

Recruiting

China,

Research Site

Wuhan, China, 430079

Recruiting

China,

Research Site

Xi'an, China, 710038

Active, not recruiting

China,

Research Site

Zhangjiagang, China, 215699

Withdrawn

China,

Research Site

Zhengzhou, China, 450000

Active, not recruiting

China,

Research Site

Zhengzhou, China, 450008

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