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Clinical Trials List

Protocol NumberD7029C00001
NCT Number(ClinicalTrials.gov Identfier)NCT06921785
Active

2025-04-01 - 2030-06-18

Phase III

Recruiting8

A Phase III, Randomised, Open-Label, Sponsor-Blinded, Multicentre Study of Rilvegostomig in Combination with Bevacizumab with or without Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma (ARTEMIDE-HCC01)

  • Trial Applicant

  • Sponsor

    ASTRAZENECA TAIWAN LIMITED

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Ying-Chun Shen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Hsiang Huang Digestive System Department
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chen-Chun Lin
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Pin-Nan Cheng Digestive System Department
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳鴻昌 Division of Hematology & Oncology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳彥豪 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hung-Wei Wang Digestive System Department
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蘇維文 Digestive System Department
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Advanced Hepatocellular Carcinoma

Objectives

The purpose of this study is to assess the efficacy and tolerability of rilvegostomig in combination with bevacizumab with or without tremelimumab as first-line treatment in participants with advanced HCC. The study comprises 2 parts - a safety lead-in and a randomised period. Prior to the start of the randomised period of the study, a single-arm safety lead-in period will be applied to evaluate the safety and tolerability of rilvegostomig in combination with bevacizumab and tremelimumab.

Test Drug

Rilvegostomig (AZD2936)
Tremelimumab
BEVACIZUMAB

Active Ingredient

Rilvegostomig (AZD2936)
Tremelimumab
BEVACIZUMAB

Dosage Form

injection
injection
injection

Dosage

750 mg/Vial
25 mg/Vial、300 mg/Vial
25 mg/mL

Endpoints

Primary Outcome Measures
To demonstrate the efficacy of Arm A relative to Arm C by assessment of OS in participants with advanced HCC

Inclution Criteria

Inclusion Criteria:
• Locally advanced or metastatic and/or unresectable HCC
• WHO/ECOG performance status of 0 or 1
• BCLC stage B (that is not eligible for locoregional therapy) or stage C. Child-Pugh Score class A
• At least one measurable target lesion
• co-infected with HBV and HCV are not eligible
• Adequate organ and bone marrow function measured during the screening period
• Must not have received prior systemic therapy for intermediate, advanced, or metastatic HCC.
• Disease that is not amenable to curative surgical and/or locoregional therapies. For participants who received locoregional therapy for HCC, locoregional therapy must have been completed ≥ 28 days prior to the baseline scan for the current study.

Exclusion Criteria

Exclusion Criteria:
Medical condition
• Any evidence of uncontrolled intercurrent diseases
• Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment
• History of another primary malignancy
• Persistent toxicities caused by previous anti-cancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
• Clinically meaningful ascites, pleural effusion, or pericardial effusion requiring non-pharmacologic intervention to maintain symptomatic control within 6 months prior to the first scheduled dose.
• History of active primary immunodeficiency or active infection
• History of hepatic encephalopathy
• Current or recent (within 10 days of first dose of study treatment) use of aspirin (≥ 325 mg/day) or treatment with dipyridamole, ticlopidine, clopidogrel, and cilostazol
• Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purposes is ineligible
Bleeding or other risks
HCC related
• Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
• Central nervous system metastases or spinal cord compression (including asymptomatic and adequately treated disease)
• Prior treatment with anti-CTLA-4 and/or anti-TIGIT.
• Radiotherapy within 28 days and abdominal/ pelvic radiotherapy within 60 days prior to initiation of study treatment, except palliative radiotherapy to bone lesions within 7 days prior to initiation of study treatment

The Estimated Number of Participants

  • Taiwan

    75 participants

  • Global

    1220 participants

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