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Hepatocellular CarcinomaPhase 3TREMENDOUSNCT05557838

Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With uHCC

A Phase 3 study testing Durvalumab and Tremelimumab in people with Hepatocellular Carcinoma, run by AstraZeneca at 29 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Durvalumab and Tremelimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
214 participants
Where
29 sitesChina
Study dates
15 Feb 2023to 30 Sep 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • For inclusion in the study, patients should fulfill the following criteria:
  • Provide written informed consent to participate in the study before the start of the study
  • Age ≥18 years at the time of study entry.
  • Body weight >30 kg.
  • Confirmed HCC based on histopathological findings from tumor tissue or radiologically findings.
  • Must not have received prior systemic therapy for HCC.
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  • At least 1 measurable lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have a short axis ≥15 mm) with computerized tomography (CT) or magnetic resonance imaging (MRI), and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines. A lesion which progressed after previous ablation or TACE could be measurable if it meets these criteria.
  • Must not be eligible for locoregional therapy for unresectable HCC. For patients who progressed after locoregional therapy for HCC, locoregional therapy must have been completed ≥28 days prior to the baseline scan for the current study.
  • Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.
  • Child-Pugh Score classification on liver disease and WHO/ECOG PS at enrolment must comply with one of the following criteria, not cumulatively:
  • Child-Pugh Score class A with WHO/ECOG PS 0-1 at enrolment will be enrolled in cohort1;
  • Child-Pugh class B with WHO/ECOG 0-1 will be enrolled in cohort 2;
  • Child-Pugh class A with WHO/ECOG 2 will be enrolled in cohort 2;

Who cannot join

  • 1) Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
  • 2）Previous study drug(s) assignment in the present study. 3）Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
  • 4）Have received an investigational product within 28 days prior to the first dose of study drug(s).
  • 5) Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria:
  • Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis.
  • Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included (eg, hearing loss).
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  • 6) Any concurrent chemotherapy, or biologic or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable.
  • 7) Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
  • 8) Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 28 days of the first dose of study drug(s).
  • 9) Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study drug(s). Note: Local surgery of isolated lesions for palliative intent is acceptable.
  • 10) History of allogeneic organ transplantation (eg, liver transplant). 11）History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy (eg, no lactulose, rifaximin, etc. if used for purposes of hepatic encephalopathy).
  • 12) Clinically meaningful ascites, defined as ascites requiring increasingly frequent non-pharmacologic intervention (eg, paracentesis) and/or escalation in pharmacologic intervention to maintain symptomatic control, within 2 months prior to the first scheduled dose. Subjects on stable doses of diuretics for ascites for ≥2 months are eligible. Also, uncontrolled pleural effusion, pericardial effusion requiring recurrent drainage procedures (once monthly or more frequently) .
  • 13）Patients with main portal vein tumor thrombosis (Vp4). 14）Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 6 months.

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

China29 sites

  • Research Site

    Beijing, 100021

  • Research Site

    Beijing, 100142

  • Research Site

    Beijing, 211405

  • Research Site

    Beijing, CN-100730

  • Research Site

    Changsha, 410005

  • Research Site

    Changsha, 410013

  • Research Site

    Chengdu, 610041

  • Research Site

    Fuzhou, 350011

  • Research Site

    Guangzhou, 510060

  • Research Site

    Guangzhou, 510100

  • Research Site

    Guangzhou, 510260

  • Research Site

    Guangzhou, 510515

  • Research Site

    Hangzhou, 310022

  • Research Site

    Harbin, 150081

  • Research Site

    Jinan, 2501117

  • Research Site

    Nanjing, 2100008

  • Research Site

    Nanjing, 210009

  • Research Site

    Nanjing, 210029

  • Research Site

    Ningbo, 315010

  • Research Site

    Shanghai, 200032

  • Research Site

    Shanghai, 200040

  • Research Site

    Shenyang, 110001

  • Research Site

    Tianjin, 300000

  • Research Site

    Wenzhou, 325000

  • Research Site

    Wuhan, 430022

  • Research Site

    Wuhan, 430079

  • Research Site

    Xi'an, 710038

  • Research Site

    Zhangjiagang, 215699

  • Research Site

    Zhengzhou, 450008

Other trials in China

About this study

Official title: An Open-label, Multi-center Phase IIIb Study of Durvalumab and Tremelimumab as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma

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.

Read the detailed description

Based on the promising result of HIMALAYA and study 22, this study is going to evaluate the efficacy and safety of Durvalumab plus Tremelimumab in Chinese population and some extended population compared to HIMALAYA, such as Child-Pugh B and, ECOG PS2.

Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DurvalumabDrug

    Also called MEDI4736

    Durvalumab IV (intravenous infusion)

  • TremelimumabDrug

    Also called There is no other names for tremelimumab.

    Tremelimumab IV (intravenous infusion) CTLA-4 inhibitor

Study groups in NCT05557838
Study groupRoleWhat they receive
cohort 1Experimentaldurvalumab in combination with tremelimumab
Receives: Drug: Durvalumab; Drug: Tremelimumab
cohort 2Experimentaldurvalumab in combination with tremelimumab
Receives: Drug: Durvalumab; Drug: Tremelimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Safety endpoint

    Measured: From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 44months

Secondary outcomes (6)

  1. ≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 2

    Safety endpoint

    Measured: From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 44 months

  2. Overall Survival (OS)

    efficacy endpoint

    Measured: From the first dose of treatment to the date of death, regardless of the actual cause of the subject's death, assessed up to 44 months

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

    efficacy endpoint

    Measured: 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

  4. Objective Response Rate (ORR) per RECIST 1.1/ mRECIST

    efficacy endpoint

    Measured: Until progression, assessed up to 15 months

  5. Disease Control Rate (DCR) per RECIST 1.1/ mRECIST

    efficacy endpoint

    Measured: Until progression, assessed up to 15 months

  6. Duration of response (DoR) per RECIST 1.1/mRECIST

    efficacy endpoint

    Measured: From the first dose, until progression, assessed up to 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2022
  2. Study start15 Feb 2023
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
214 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05557838
Sponsor's protocol ID
D419CR00026
Acronym
TREMENDOUS
Status last verified
Jun 2026
First submitted
14 Sep 2022
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Durvalumab and Tremelimumab in people with Hepatocellular Carcinoma, run by AstraZeneca at 29 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 1 (time frame: From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 44months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05557838.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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