NCT05557838

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P25-P50 for phase_3 hepatocellular-carcinoma

Timeline
Completed

Started Feb 2023

Shorter than P25 for phase_3 hepatocellular-carcinoma

Geographic Reach
1 country

32 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

February 22, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

2.1 years

First QC Date

September 14, 2022

Last Update Submit

February 6, 2025

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • ≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 1

    From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 29 months

Secondary Outcomes (7)

  • ≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 2

    From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 29 months

  • Overall Survival (OS)

    From the first dose of treatment to the date of death, regardless of the actual cause of the subject's death, assessed up to 29 months

  • Progression Free Survival (PFS) per RECIST v1.1/mRECIST

    From first dose of treatment until progression per RECIST 1.1/ mRECIST as assessed by the Investigator or death due to any cause prior to progression, assessed up to 15 months

  • Objective Response Rate (ORR) per RECIST 1.1/ mRECIST

    Until progression, assessed up to 15 months

  • Disease Control Rate (DCR) per RECIST 1.1/ mRECIST

    Until progression, assessed up to 15 months

  • +2 more secondary outcomes

Study Arms (2)

cohort 1

EXPERIMENTAL

durvalumab in combination with tremelimumab

Drug: DurvalumabDrug: Tremelimumab

cohort 2

EXPERIMENTAL

durvalumab in combination with tremelimumab

Drug: DurvalumabDrug: Tremelimumab

Interventions

DurvalumabDRUG

Durvalumab IV (intravenous infusion)

Also known as: MEDI4736
cohort 1cohort 2
TremelimumabDRUG

Tremelimumab IV (intravenous infusion)

cohort 1cohort 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Research Site

Beijing, 100021, China

ACTIVE NOT RECRUITING

Research Site

Beijing, 100142, China

ACTIVE NOT RECRUITING

Research Site

Beijing, 211405, China

ACTIVE NOT RECRUITING

Research Site

Beijing, CN-100730, China

ACTIVE NOT RECRUITING

Research Site

Changsha, 410005, China

COMPLETED

Research Site

Changsha, 410013, China

ACTIVE NOT RECRUITING

Research Site

Chengdu, 610041, China

ACTIVE NOT RECRUITING

Research Site

Fuzhou, 350011, China

ACTIVE NOT RECRUITING

Research Site

Guangzhou, 510060, China

ACTIVE NOT RECRUITING

Research Site

Guangzhou, 510100, China

ACTIVE NOT RECRUITING

Research Site

Guangzhou, 510260, China

ACTIVE NOT RECRUITING

Research Site

Guangzhou, 510515, China

ACTIVE NOT RECRUITING

Research Site

Hangzhou, 310022, China

ACTIVE NOT RECRUITING

Research Site

Harbin, 150081, China

ACTIVE NOT RECRUITING

Research Site

Jinan, 2501117, China

RECRUITING

Research Site

Nanjing, 2100008, China

ACTIVE NOT RECRUITING

Research Site

Nanjing, 210009, China

ACTIVE NOT RECRUITING

Research Site

Nanjing, 210029, China

ACTIVE NOT RECRUITING

Research Site

Ningbo, 315010, China

ACTIVE NOT RECRUITING

Research Site

Shanghai, 200032, China

ACTIVE NOT RECRUITING

Research Site

Shanghai, 200040, China

ACTIVE NOT RECRUITING

Research Site

Shenyang, 110001, China

ACTIVE NOT RECRUITING

Research Site

Tianjin, 300000, China

ACTIVE NOT RECRUITING

Research Site

Tianjin, 300060, China

WITHDRAWN

Research Site

Tianjin, 300170, China

WITHDRAWN

Research Site

Wenzhou, 325000, China

ACTIVE NOT RECRUITING

Research Site

Wuhan, 430022, China

ACTIVE NOT RECRUITING

Research Site

Wuhan, 430079, China

ACTIVE NOT RECRUITING

Research Site

Xi'an, 710038, China

ACTIVE NOT RECRUITING

Research Site

Zhangjiagang, 215699, China

ACTIVE NOT RECRUITING

Research Site

Zhengzhou, 450000, China

WITHDRAWN

Research Site

Zhengzhou, 450008, China

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

durvalumabtremelimumab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479information.center@astrazeneca.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2022

First Posted

September 28, 2022

Study Start

February 22, 2023

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

February 7, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient- level data from AstraZeneca group of companies sponsored clinical trials via the request portal. Plan Description: All request will be evaluated as per the Az disclosure commitment: https://astrazenecaarouptrials.pharmacm.com/ST/Submission/Disclosure Yes. indicates that Az are accepting requests for IPD ,but this does not mean are quests will be shared

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
AstraZeneca will meet or exceed data availability as per the commitment at made to the EFPIA Pharma Data Sharing Principles .For details of our timeline please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement(non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to a air access. For additional details. please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
More information

Locations

CN(32)