Evidence map›Paper›PMID 40128285›Full record

Trial reportBritish journal of cancer2025

Prompt initiation of durvalumab and tremelimumab for unresectable hepatocellular carcinoma in patients with chronic active hepatitis B: a phase 2 clinical trial.

Yu-Yun Shao, Ching-Tso Chen, Chien-Huai Chuang, Tung-Hung Su, Ming-Chih Ho, Tai-Chung Tseng, Tsung-Hao Liu, Tsung-Che Wu, Ann-Lii Cheng, Chih-Hung Hsu

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in British journal of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04294498 (A Phase II Study of Durvalumab), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04294498 phase2completednot on this map

A Phase II Study of Durvalumab (MEDI 4736) for Advanced Hepatocellular Carcinoma in Patients With Active Chronic Hepatitis B Virus Infection

TypeinterventionalSponsorNational Taiwan University HospitalRan2020 to 2026Enrolled30ConditionsAdvanced Hepatocellular CarcinomaArmsDurvalumab
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Review
  3. Nanocarrier-based immunotherapy for viral diseases.International journal of pharmaceutics: X · 2025
    Review
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Yu-Yun ShaoDepartment of Oncology, National Taiwan University Hospital, Taipei, Taiwan. yuyunshao@gmail.com.ORCID http://orcid.org/0000-0001-7334-1912
Ching-Tso ChenDepartment of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
Chien-Huai ChuangDepartment of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
Tung-Hung SuDepartment of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
Ming-Chih HoDepartment of Surgery, National Taiwan University Hospital, Taipei, Taiwan.
Tai-Chung TsengDepartment of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
Tsung-Hao LiuDepartment of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
Tsung-Che WuDepartment of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
Ann-Lii ChengDepartment of Oncology, National Taiwan University Hospital, Taipei, Taiwan.ORCID http://orcid.org/0000-0002-9152-6512
Chih-Hung HsuDepartment of Oncology, National Taiwan University Hospital, Taipei, Taiwan.

Funding

Ministry of Health and Welfare (Ministry of Health and Welfare, Taiwan) MOHW112-TDU-B-211-144002National Taiwan University Hospital (NTUH) NTUH. 108-S4150
6 · The paper itself

Abstract

backgroundChronic hepatitis B virus (HBV) infection is an etiology of HCC, but clinical trials using immune checkpoint inhibitors (ICIs) usually exclude patients with chronic active hepatitis B (serum HBV viral load > 2000 IU/mL). This study examined the safety and efficacy of concurrently administering the ICI and anti-HBV medications in this patient population.

methodsIn this single-arm phase 2 clinical trial, we enrolled patients with advanced HCC and untreated chronic active hepatitis B. Patients received 1500 mg of durvalumab every 4 weeks alone or in combination with 300 mg of tremelimumab on day 1 (the STRIDE regimen). Anti-HBV treatment with entecavir was simultaneously initiated. The primary endpoint was the rate of HBV reactivation.

resultsWe enrolled 30 patients, whose mean baseline HBV viral load was 770,986 IU/mL. No patients experienced HBV reactivation or HBV-associated hepatitis. Hepatitis flare was noted in 8 (26.7%) patients, but none of them were associated with HBV reactivation. The objective tumor response rate was 10% and 25% for the durvalumab treatment alone and the STRIDE regimen, respectively.

conclusionFor patients with chronic active hepatitis B, ICI therapy could be promptly initiated as long as anti-HBV medications were administered simultaneously. CLINICAL

trial registrationNCT04294498.

Indexed as

Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, HepatocellularHepatitis B, ChronicLiver NeoplasmsAdultAgedFemaleHepatitis B virusHumansMaleMiddle AgedAntibodies, MonoclonalAntibodies, Monoclonal, Humanizeddurvalumabtremelimumab

Identifiers

PMID40128285
PMCPMC12041533

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.