Evidence map›Paper›PMID 12865912›Full record

Trial reportBritish journal of cancer2003

A phase II study of the vitamin D analogue Seocalcitol in patients with inoperable hepatocellular carcinoma.

K Dalhoff, J Dancey, L Astrup, T Skovsgaard, K J Hamberg, F J Lofts, O Rosmorduc, S Erlinger, J Bach Hansen, W P Steward and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical TrialClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in British journal of cancer, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02779465 (Study of Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma in Patients With Chronic Hepatitis B), which is not on this map. Cited by 57 papers.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed
6.6field-weighted citation impact, top 3% 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.

NCT02779465 phase4not yet recruitingnot on this mapstarted 2016, after this paper: background citation

Study of Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma in Patients With Chronic Hepatitis B

TypeinterventionalSponsorThird Affiliated Hospital, Sun Yat-Sen UniversityRan2016 to 2026Enrolled1,500ConditionsHepatitis B, Carcinoma, HepatocellularArmsVitamin D3
3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 170 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. Review
  11. Review
  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

13 authors at 10 institutions in 4 countries.

K DalhoffDepartment of Clinical Pharmacology, Rigshospitalet, Denmark [2] 2Department of Hepatology, Rigshospitalet, Denmark. dalhoff@rh.dk
J Dancey
L Astrup
T Skovsgaard
K J Hamberg
F J Lofts
O Rosmorduc
S Erlinger
J Bach Hansen
W P Steward
T Skov
F Burcharth
T R J Evans
Herlev Hospital · DKLeo Pharma (Denmark) · DKAalborg University Hospital · DKAarhus Municipality · DKHôpital Saint-Antoine · FRLeicester Royal Infirmary · GBPrincess Margaret Cancer Centre · CARigshospitalet · DKSt George's Hospital · GBUniversity of Glasgow · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Hepatocellular carcinoma (HCC) is a common malignant tumour, which has a poor prognosis. Surgical resection can be curative but most patients are inoperable and most chemotherapy agents have minimal activity in this disease. Seocalcitol, a vitamin D analogue, induces differentiation and inhibits growth in cancer cell lines and in vivo. The vitamin D receptor is expressed in hepatocytes and more abundantly in HCC cells. In total, 56 patients with inoperable advanced HCC were included in an uncontrolled study of oral Seocalcitol treatment for up to 1 year (with possible extension for responders). The dose was titrated according to serum calcium levels. The treatment effect was evaluated by regular CT scans. Out of 33 patients evaluable for tumour response, two had complete response (CR), 12 stable disease and 19 progressive disease. The CRs appeared after 6 and 24 months of treatment, and lasted for 29 and at least 36 months (patient still in remission when data censored). Seocalcitol was well tolerated; the most frequent toxicity was hypercalcaemia and related symptoms. Most patients tolerated a daily dose of 10 micro g of Seocalcitol. This is the first study showing activity, by reduction in tumour dimensions, of a differentiating agent in patients with an advanced bulky, solid tumour. Seocalcitol may have an effect in the treatment of HCC, especially in early disease when a prolonged treatment can be instituted. The survival benefit with or without tumour response should be determined in controlled studies.

Indexed as

Administration, OralAdultAgedAged, 80 and overAntineoplastic AgentsCalcitriolCarcinoma, HepatocellularDisease ProgressionFemaleHumansLiver NeoplasmsMaleMiddle AgedReceptors, CalcitriolTreatment OutcomeAntineoplastic AgentsCalcitriolReceptors, Calcitriolseocalcitol

Identifiers

PMID12865912
PMCPMC2394267
OpenAlexW2021926444

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.