Evidence map›Paper›PMID 25895027›Full record

Trial reportOncotarget2015

An open-label, single-arm, phase I/II study of lower-dose decitabine based therapy in patients with advanced hepatocellular carcinoma.

Qian Mei, Meixia Chen, Xuechun Lu, Xiang Li, Feng Duan, Maoqiang Wang, Guangbin Luo, Weidong Han

Registry-linked trialOpen access · diamondAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Oncotarget, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02961101 (Anti-PD-1 Antibody Alone or in Combination With Low-dose Decitabine and/or Chemotherapy in Relapsed or Refractory Malignancies), which is not on this map. Cited by 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed
2.0field-weighted citation impact, top 14% 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.

NCT02961101 phase1 / phase2recruitingnot on this mapstarted 2016, after this paper: background citation

Anti-PD-1 Antibody Alone or in Combination With Low-dose Decitabine and/or Chemotherapy in Relapsed or Refractory Malignancies: an Open-label Phase I/II Trial

TypeinterventionalSponsorHan weidongRan2016 to 2026Enrolled250ConditionsMalignancies MultipleArmsAnti-PD-1 antibody, Decitabine, Chemotherapy
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 47 citations in OpenAlex.

  1. Trial
  2. Crosstalk BetweenCancers · 2026
    Review
  3. Review
  4. Review
  5. Hepatocellular carcinoma: signaling pathways and therapeutic advances.Signal transduction and targeted therapy · 2025
    Review
  6. Review
  7. Article
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. 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

8 authors at 1 institution in 2 countries.

Qian MeiDepartment of Molecular Biology, School of Life Sciences, Chinese PLA General Hospital, Beijing, P. R. China.
Meixia ChenDepartment of Molecular Biology, School of Life Sciences, Chinese PLA General Hospital, Beijing, P. R. China.
Xuechun LuDepartment of Molecular Biology, School of Life Sciences, Chinese PLA General Hospital, Beijing, P. R. China.
Xiang LiDepartment of Molecular Biology, School of Life Sciences, Chinese PLA General Hospital, Beijing, P. R. China.
Feng DuanDepartment of Interventional Radiology, Chinese PLA General Hospital, Beijing, P. R. China.
Maoqiang WangDepartment of Interventional Radiology, Chinese PLA General Hospital, Beijing, P. R. China.
Guangbin LuoDepartment of Molecular Biology, School of Life Sciences, Chinese PLA General Hospital, Beijing, P. R. China.
Weidong HanDepartment of Molecular Biology, School of Life Sciences, Chinese PLA General Hospital, Beijing, P. R. China.
Chinese PLA General Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe conducted this phase I/II clinical trial to determine the safety and efficacy of lower-dose decitabine based therapy in pretreated patients with advanced HCC. EXPERIMENTAL

designPatients with advanced HCC were eligible. The administered dose of decitabine was 6 mg/m2/d intravenously on days 1 to 5 of a 28-day cycle. Additional therapies were given based on their disease progression status. The endpoint was to ensure the safety, hepatotoxicity, clinical responses, progression-free survival (PFS) and pharmacodynamics assay of lower-dose decitabine.

resultsFifteen patients were enrolled. The favorable adverse events and liver function profiles were observed. The most beneficial responses were 1 complete response (CR), 6 stable disease (SD) and 8 progressive disease (PD). MRI liver scans post-treatment indicated a unique and specific characteristic. The immunohistochemistry result from the liver biopsy exhibited noteworthy CTL responses. Median PFS was 4 months (95% CI 1.7, 7), comparing favorably with existing therapeutic options. Expression decrement of DNMT1 and global DNA hypomethylation were observed in PBMCs after lower-dose decitabine treatment.

conclusionThe lower-dose decitabine based treatment resulted in beneficial clinical response and favorable toxicity profiles in patients with advanced HCC. The prospective evaluations of decitabine administration schemes and tumor tissue-based pharmacodynamics effect are warranted in future trials.

Indexed as

AdultAgedAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsAzacitidineCarcinoma, HepatocellularDecitabineDisease-Free SurvivalDNA (Cytosine-5-)-Methyltransferase 1DNA (Cytosine-5-)-MethyltransferasesDNA MethylationDNA Modification MethylasesFemaleHumansLiver NeoplasmsMaleAntimetabolites, AntineoplasticAzacitidineDecitabineDNA (Cytosine-5-)-Methyltransferase 1DNA (Cytosine-5-)-MethyltransferasesDNA Modification MethylasesDNMT1 protein, humanadvanced hepatocellular carcinomadecitabinehepatotoxicitylower dosephase I/II

Identifiers

PMID25895027
PMCPMC4599300
OpenAlexW1825553076

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.