Evidence map›Paper›PMID 38042834›Full record

ArticleTrials2023

The effect of switch therapy to tenofovir versus entecavir maintenance on recurrence of hepatocellular carcinoma after surgery (SWITE): study protocol for a randomized controlled trial.

Wei Peng, Mengshi Yi, Xin Qi, Weili Qi, Chuan Li, Tianfu Wen

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 69% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

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

6 authors at 2 institutions in 1 country.

Wei PengDivision of Liver Surgery, Department of General Surgery, West China Hospital, Sichuan University, Chengdu, 610041, China.
Mengshi YiDeparment of Hepatobiliary Surgery, the First Affiliated Hospital of Army Medical University, Chongqing, China.
Xin QiWest China School of Medicine, Sichuan University, Chengdu, China.
Weili QiDivision of Liver Surgery, Department of General Surgery, West China Hospital, Sichuan University, Chengdu, 610041, China.
Chuan LiDivision of Liver Surgery, Department of General Surgery, West China Hospital, Sichuan University, Chengdu, 610041, China.
Tianfu WenDivision of Liver Surgery, Department of General Surgery, West China Hospital, Sichuan University, Chengdu, 610041, China. wentianfu@scu.edu.cn.ORCID http://orcid.org/0000-0003-1871-272X
Sichuan University · CNArmy Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAntiviral therapy has been reported to be associated with lower recurrence rate of hepatocellular carcinoma (HCC) for patients with hepatitis B virus (HBV) infection. While entecavir (ETV) and tenofovir disoproxil fumarate (TDF) were both recommended as first-line therapies for HBV patients, recent retrospective studies proposed a lower incidence rate of HCC occurrence or recurrence in those receiving TDF compared ETV. However, the survival benefits of switching to TDF therapy after prolonged ETV treatment before surgery remain uncertain. We delineate the rationale and design of SWITE, a randomized, open-label, phase III trial contrasting TDF switch therapy versus ETV maintenance in HBV-related HCC patients. METHODS AND ANALYSIS: This is a prospective, randomized, controlled, single-center study with two parallel groups of patients with HBV-related HCC who have received long-term ETV therapy before surgery. West China Hospital will enroll 238 patients, randomized in a 1:1 ratio to TDF switch therapy or ETV maintenance after surgery. The primary endpoint of this study is 3-year recurrence free survival (RFS), with the secondary endpoint being 3-year overall survival (OS) after curative surgery of HCC. Safety events will be diligently recorded. ETHICS AND DISSEMINATION: The study protocol aligns with the ethical guidelines of the 1975 Declaration of Helsinki. It was approved by ethics committee of West China Hospital (approval number: 2022-074) and was registered with chictr.org.cn (chiCTR2200057867). Informed consent will be obtained from all participants. The results of this trial will be published in peer-reviewed journals and presentations at national and international conferences relevant to this topic.

trial registrationchiCTR2200057867 . Date of registration is March 20 2022.

Indexed as

Carcinoma, HepatocellularHepatitis BHepatitis B, ChronicLiver NeoplasmsAntiviral AgentsGuanineHepatitis B virusHumansProspective StudiesRandomized Controlled Trials as TopicRetrospective StudiesTenofovirTreatment OutcomeAntiviral AgentsentecavirGuanineTenofovirAntiviral therapyEntecavirHepatocellular carcinomaRecurrenceTenofovir disoproxil fumarate

Identifiers

PMID38042834
PMCPMC10693690
OpenAlexW4389270128

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.