Evidence map›Paper›PMID 29888206›Full record

ArticleLiver cancer2018

A Phase I/Randomized Phase II Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Nintedanib versus Sorafenib in Asian Patients with Advanced Hepatocellular Carcinoma.

Chia-Jui Yen, Tae-You Kim, Yin-Hsun Feng, Yee Chao, Deng-Yn Lin, Baek-Yeol Ryoo, Dennis Chin-Lun Huang, David Schnell, Julia Hocke, Arsène-Bienvenu Loembé and 1 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Liver cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 5 pooled it
1.7field-weighted citation impact, top 15% 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

22 citing papers in PubMed, 5 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Pooled it
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  3. Objective Response Predicts Survival in Advanced Hepatocellular Carcinoma Treated with Systemic Therapies.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
    Pooled it
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  5. Guideline
  6. Hepatocellular carcinoma: signaling pathways and therapeutic advances.Signal transduction and targeted therapy · 2025
    Review
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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

11 authors at 10 institutions in 4 countries.

Chia-Jui YenDivision of Hematology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Tae-You KimSeoul National University Hospital, Seoul, Republic of Korea.
Yin-Hsun FengChi Mei Medical Center, Yongkang, Tainan, Taiwan.
Yee ChaoTaipei Veterans General Hospital, Taipei, Taiwan.
Deng-Yn LinChang Gung Memorial Hospital & Chang Gung University, College of Medicine, Taoyuan, Taiwan.
Baek-Yeol RyooAsan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Dennis Chin-Lun HuangBoehringer Ingelheim Taiwan Limited, Taipei, Taiwan.
David SchnellBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
Julia HockeBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
Arsène-Bienvenu LoembéBoehringer Ingelheim B.V., Alkmaar, the Netherlands.
Ann-Lii ChengNational Taiwan University Hospital, Taipei, Taiwan.
Boehringer Ingelheim (Germany) · DEAsan Medical Center · KRBoehringer Ingelheim (Netherlands) · NLBoehringer Ingelheim (Taiwan) · TWChang Gung University · TWChi Mei Medical Center · TWNational Cheng Kung University Hospital · TWNational Taiwan University Hospital · TWSeoul National University Hospital · KRTaipei Veterans General Hospital · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNintedanib is an oral, triple angiokinase inhibitor of vascular endothelial growth factor/platelet-derived growth factor/fibroblast growth factor receptors. This randomized, multicenter, open-label, phase I/II study evaluated the safety, pharmacokinetics, maximum tolerated dose (MTD) in terms of dose-limiting toxicities (DLTs), and efficacy of nintedanib versus sorafenib in Asian patients with unresectable advanced hepatocellular carcinoma (HCC). PATIENTS AND

methodsFor the phase I portion, patients were stratified into two groups according to their alanine aminotransferase/aspartate aminotransferase (ALT/AST) and Child-Pugh score at baseline. For phase I, the primary endpoint was determination of the MTD in terms of DLTs. For phase II, patients with a Child-Pugh score of 5-6, an Eastern Cooperative Oncology Group performance score ≤2, and an ALT/AST ≤2× the upper limit of normal were enrolled and randomized 2: 1 to nintedanib 200 mg twice daily (b.i.d.) (the MTD determined in phase I) or sorafenib 400 mg b.i.d. continuously in 28-day cycles until intolerable adverse events (AEs) or disease progression (PD); treatment beyond PD was allowed if clinical benefit was perceived. The primary endpoint for phase II was time to progression (TTP) by central independent review (CIR; by Response Evaluation Criteria in Solid Tumors v1.0); the secondary endpoints included overall survival (OS). All analyses were exploratory.

resultsThe MTD was 200 mg in both groups. For phase II, 95 patients were randomized to nintedanib (

conclusionsNintedanib showed numerically similar efficacy to sorafenib for CIR TTP and OS in Asian patients with advanced HCC and adequate liver function. AEs were generally manageable.

Indexed as

Advanced hepatocellular carcinomaAngiokinase inhibitorDose-limiting toxicityMaximum tolerated doseNintedanibSorafenib

Identifiers

PMID29888206
PMCPMC5985414
OpenAlexW2791462602

What OpenQuestion holds

Textmetadata
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.