All-trans-retinoic acid versus FOLFOX alone as palliative chemotherapy in patients with advanced hepatocellular carcinoma and extrahepatic metastasis: study protocol for a randomized controlled trial

Background Among patients with hepatocellular carcinoma (HCC), 85% of patients have an advanced disease stage at diagnosis and curative therapies cannot be performed. Prognosis has been quite poor as until recently there was no proven effective chemotherapy. Our group found that all-trans-retinoic a...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Trials Jg. 20; H. 1
Hauptverfasser: Shi, Jie, Sun, Juxian, Liu, Chang, Chai, Zongtao, Wang, Nanya, Zhang, Hui, Cheng, Shuqun
Format: Journal Article
Sprache:Englisch
Veröffentlicht: BioMed Central Ltd 29.04.2019
Schlagworte:
Analysis
Anopheles
Antineoplastic agents
Cancer
Cancer metastasis
Carcinoma
Chemotherapy
Clinical trials
Comparative analysis
Drug therapy
Fluorouracil
Hepatocellular carcinoma
Oxaliplatin
Surgery
Tretinoin
Tumors
ISSN:1745-6215, 1745-6215
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
Abstract Background Among patients with hepatocellular carcinoma (HCC), 85% of patients have an advanced disease stage at diagnosis and curative therapies cannot be performed. Prognosis has been quite poor as until recently there was no proven effective chemotherapy. Our group found that all-trans-retinoic acid (ATRA) could improve the efficacy of platinum in HCC in vivo and in vitro, thus we wish to validate the efficiency of ATRA in clinical practice. Methods This is a double-blinded, 1:1 randomized, controlled, multicenter clinical trial. Three hundred and sixty-eight patients with HCC and extrahepatic metastases will receive palliative chemotherapy at the Eastern Hepatobiliary Surgery Hospital, First Hospital of Jilin University and Fujian Provincial Cancer Hospital. Subjects will be randomly assigned to one of the two arms, either ATRA + oxaliplatin + 5-fluorouracil/leucovorin (FOLFOX4) or FOLFOX4 alone. ATRA 20 mg will be given orally three times/day for 3 days prior to the initiation of FOLFOX4. ATRA will be discontinued at the end of FOLFOX4. Discussion Overall survival rate is the primary endpoint. Secondary endpoints are time to progression according to the modified response evaluation criteria in solid tumors (mRECIST) criteria, acute and chronic adverse events, and quality of life. Trial registration Chinese Clinical Trial Registry, ChiCTR-IIR-17012916. Registered on 9 October 2017. Keywords: Extrahepatic metastasis, FOLFOX4, ATRA, Palliative chemotherapy
AbstractList Background Among patients with hepatocellular carcinoma (HCC), 85% of patients have an advanced disease stage at diagnosis and curative therapies cannot be performed. Prognosis has been quite poor as until recently there was no proven effective chemotherapy. Our group found that all-trans-retinoic acid (ATRA) could improve the efficacy of platinum in HCC in vivo and in vitro, thus we wish to validate the efficiency of ATRA in clinical practice. Methods This is a double-blinded, 1:1 randomized, controlled, multicenter clinical trial. Three hundred and sixty-eight patients with HCC and extrahepatic metastases will receive palliative chemotherapy at the Eastern Hepatobiliary Surgery Hospital, First Hospital of Jilin University and Fujian Provincial Cancer Hospital. Subjects will be randomly assigned to one of the two arms, either ATRA + oxaliplatin + 5-fluorouracil/leucovorin (FOLFOX4) or FOLFOX4 alone. ATRA 20 mg will be given orally three times/day for 3 days prior to the initiation of FOLFOX4. ATRA will be discontinued at the end of FOLFOX4. Discussion Overall survival rate is the primary endpoint. Secondary endpoints are time to progression according to the modified response evaluation criteria in solid tumors (mRECIST) criteria, acute and chronic adverse events, and quality of life. Trial registration Chinese Clinical Trial Registry, ChiCTR-IIR-17012916. Registered on 9 October 2017. Keywords: Extrahepatic metastasis, FOLFOX4, ATRA, Palliative chemotherapy
Among patients with hepatocellular carcinoma (HCC), 85% of patients have an advanced disease stage at diagnosis and curative therapies cannot be performed. Prognosis has been quite poor as until recently there was no proven effective chemotherapy. Our group found that all-trans-retinoic acid (ATRA) could improve the efficacy of platinum in HCC in vivo and in vitro, thus we wish to validate the efficiency of ATRA in clinical practice. This is a double-blinded, 1:1 randomized, controlled, multicenter clinical trial. Three hundred and sixty-eight patients with HCC and extrahepatic metastases will receive palliative chemotherapy at the Eastern Hepatobiliary Surgery Hospital, First Hospital of Jilin University and Fujian Provincial Cancer Hospital. Subjects will be randomly assigned to one of the two arms, either ATRA + oxaliplatin + 5-fluorouracil/leucovorin (FOLFOX4) or FOLFOX4 alone. ATRA 20 mg will be given orally three times/day for 3 days prior to the initiation of FOLFOX4. ATRA will be discontinued at the end of FOLFOX4. Overall survival rate is the primary endpoint. Secondary endpoints are time to progression according to the modified response evaluation criteria in solid tumors (mRECIST) criteria, acute and chronic adverse events, and quality of life.
Audience Academic
Author Sun, Juxian
Zhang, Hui
Cheng, Shuqun
Shi, Jie
Chai, Zongtao
Liu, Chang
Wang, Nanya
Author_xml – sequence: 1
  fullname: Shi, Jie
– sequence: 2
  fullname: Sun, Juxian
– sequence: 3
  fullname: Liu, Chang
– sequence: 4
  fullname: Chai, Zongtao
– sequence: 5
  fullname: Wang, Nanya
– sequence: 6
  fullname: Zhang, Hui
– sequence: 7
  fullname: Cheng, Shuqun
BookMark eNptUMFu2zAMFYYMaNL2A3ojsLM7y7JsZ7egWLYCAXLpobeAkehEgywFkpKt-8H9Volthx4KEiBBvsf3wIWYhRhIiDtZ30s5dJ-zVHWnqlouK6XaZbX8IOayb3XVNVLP3vRXYpHzj7pu1VK1c_Fn5X1VEoZcJSouRGcAjbNwoZTPGdbbzXr7DOhZDjDDCb13WNyFwBxpiuVICU8v4AKviqNQMvx05QhoLxgMWTgSL6Ih788eExhMhmUmBAwW6Bdr_0Ww7kQFM6fLXyCXs32BU4pMjR7GmACBbdo4ud981cRQUvSe25Ic-hvxcUSf6fZ_vRZP669PD9-rzfbb48NqUx26vuYH1FI2PdvCcRjt3lI_NHvT6VGhUWhNa7Wi3g66HzplNNqmRa1No6kZmaOuxad_Zw_oaefCGNm_mVw2u5UeOq300NeMun8HxWFpcuycRsfzN4RXiHeRSg
ContentType Journal Article
Copyright COPYRIGHT 2019 BioMed Central Ltd.
Copyright_xml – notice: COPYRIGHT 2019 BioMed Central Ltd.
DOI 10.1186/s13063-019-3349-9
DatabaseTitleList

DeliveryMethod fulltext_linktorsrc
Discipline Medicine
EISSN 1745-6215
ExternalDocumentID A586535870
GroupedDBID ---
0R~
123
2-G
29Q
2WC
53G
5VS
6PF
7RV
7X7
88E
8FI
8FJ
AAFWJ
AAJSJ
AASML
AAWTL
ABDBF
ABUWG
ACGFO
ACGFS
ACUHS
ADBBV
ADRAZ
ADUKV
AEGXH
AENEX
AFFHD
AFKRA
AFPKN
AHBYD
AHYZX
AIAGR
ALMA_UNASSIGNED_HOLDINGS
AMKLP
AMTXH
AOIJS
BAPOH
BAWUL
BCNDV
BENPR
BFQNJ
BMC
C6C
CCPQU
CS3
DIK
DU5
E3Z
EBD
EBLON
EBS
EJD
EMOBN
ESX
F5P
FYUFA
GROUPED_DOAJ
GX1
HMCUK
HYE
IAO
IHR
INH
INR
ITC
KQ8
M1P
M48
M~E
NAPCQ
O5R
O5S
OVT
PGMZT
PHGZM
PHGZT
PIMPY
PJZUB
PPXIY
PSQYO
RBZ
RNS
ROL
RPM
RSV
SMD
SOJ
SV3
TR2
TUS
U2A
UKHRP
WOQ
WOW
~8M
ID FETCH-LOGICAL-g670-6201127cedaf8fdbde782bc65f3ac3adc4d53e7d857863c5ad24a55c25e2fdaf3
ISSN 1745-6215
IngestDate Tue Nov 11 10:05:14 EST 2025
Tue Nov 04 17:43:32 EST 2025
IsPeerReviewed true
IsScholarly true
Issue 1
Language English
LinkModel OpenURL
MergedId FETCHMERGED-LOGICAL-g670-6201127cedaf8fdbde782bc65f3ac3adc4d53e7d857863c5ad24a55c25e2fdaf3
ParticipantIDs gale_infotracmisc_A586535870
gale_infotracacademiconefile_A586535870
PublicationCentury 2000
PublicationDate 20190429
PublicationDateYYYYMMDD 2019-04-29
PublicationDate_xml – month: 04
  year: 2019
  text: 20190429
  day: 29
PublicationDecade 2010
PublicationTitle Trials
PublicationYear 2019
Publisher BioMed Central Ltd
Publisher_xml – name: BioMed Central Ltd
SSID ssj0043934
Score 2.1808193
Snippet Background Among patients with hepatocellular carcinoma (HCC), 85% of patients have an advanced disease stage at diagnosis and curative therapies cannot be...
Among patients with hepatocellular carcinoma (HCC), 85% of patients have an advanced disease stage at diagnosis and curative therapies cannot be performed....
SourceID gale
SourceType Aggregation Database
SubjectTerms Analysis
Anopheles
Antineoplastic agents
Cancer
Cancer metastasis
Carcinoma
Chemotherapy
Clinical trials
Comparative analysis
Drug therapy
Fluorouracil
Hepatocellular carcinoma
Oxaliplatin
Surgery
Tretinoin
Tumors
Title All-trans-retinoic acid versus FOLFOX alone as palliative chemotherapy in patients with advanced hepatocellular carcinoma and extrahepatic metastasis: study protocol for a randomized controlled trial
Volume 20
hasFullText 1
inHoldings 1
isFullTextHit
isPrint
journalDatabaseRights – providerCode: PRVADU
  databaseName: BioMedCentral
  customDbUrl:
  eissn: 1745-6215
  dateEnd: 99991231
  omitProxy: false
  ssIdentifier: ssj0043934
  issn: 1745-6215
  databaseCode: RBZ
  dateStart: 20060101
  isFulltext: true
  titleUrlDefault: https://www.biomedcentral.com/search/
  providerName: BioMedCentral
– providerCode: PRVAON
  databaseName: DOAJ (Directory of Open Access Journals)
  customDbUrl:
  eissn: 1745-6215
  dateEnd: 99991231
  omitProxy: false
  ssIdentifier: ssj0043934
  issn: 1745-6215
  databaseCode: DOA
  dateStart: 20060101
  isFulltext: true
  titleUrlDefault: https://www.doaj.org/
  providerName: Directory of Open Access Journals
– providerCode: PRVHPJ
  databaseName: ROAD: Directory of Open Access Scholarly Resources
  customDbUrl:
  eissn: 1745-6215
  dateEnd: 99991231
  omitProxy: false
  ssIdentifier: ssj0043934
  issn: 1745-6215
  databaseCode: M~E
  dateStart: 20060101
  isFulltext: true
  titleUrlDefault: https://road.issn.org
  providerName: ISSN International Centre
– providerCode: PRVPQU
  databaseName: Health & Medical Collection
  customDbUrl:
  eissn: 1745-6215
  dateEnd: 99991231
  omitProxy: false
  ssIdentifier: ssj0043934
  issn: 1745-6215
  databaseCode: 7X7
  dateStart: 20000401
  isFulltext: true
  titleUrlDefault: https://search.proquest.com/healthcomplete
  providerName: ProQuest
– providerCode: PRVPQU
  databaseName: Nursing & Allied Health Database
  customDbUrl:
  eissn: 1745-6215
  dateEnd: 99991231
  omitProxy: false
  ssIdentifier: ssj0043934
  issn: 1745-6215
  databaseCode: 7RV
  dateStart: 20000401
  isFulltext: true
  titleUrlDefault: https://search.proquest.com/nahs
  providerName: ProQuest
– providerCode: PRVPQU
  databaseName: ProQuest Central
  customDbUrl:
  eissn: 1745-6215
  dateEnd: 99991231
  omitProxy: false
  ssIdentifier: ssj0043934
  issn: 1745-6215
  databaseCode: BENPR
  dateStart: 20000401
  isFulltext: true
  titleUrlDefault: https://www.proquest.com/central
  providerName: ProQuest
– providerCode: PRVPQU
  databaseName: Publicly Available Content Database
  customDbUrl:
  eissn: 1745-6215
  dateEnd: 99991231
  omitProxy: false
  ssIdentifier: ssj0043934
  issn: 1745-6215
  databaseCode: PIMPY
  dateStart: 20000401
  isFulltext: true
  titleUrlDefault: http://search.proquest.com/publiccontent
  providerName: ProQuest
– providerCode: PRVAVX
  databaseName: SpringerLink Contemporary
  customDbUrl:
  eissn: 1745-6215
  dateEnd: 99991231
  omitProxy: false
  ssIdentifier: ssj0043934
  issn: 1745-6215
  databaseCode: RSV
  dateStart: 20000401
  isFulltext: true
  titleUrlDefault: https://link.springer.com/search?facet-content-type=%22Journal%22
  providerName: Springer Nature
link http://cvtisr.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwtZ1Li9RAEMebcRXxIj5xdV3qIHgI0Uw6nU68DbKDyD4E5zB4WTqdzm4gkyybzDJ48OsJfiqrO53HOCJ68BJCHpNO6kdVTfe_ugl5FSVoy0RSF2ObcgNEyI1CKV2RJTTidBooT5jFJvjpabRcxp8mkx9dLcxNwcsy2mziq_9qajyGxtals_9g7v5H8QDuo9Fxi2bH7V8ZflYUbqMjkKsLFMtKT8gq89TR-ot17czPjudnS0cUFaaXonauhO5wMQIitN_KFmSZakA752pXANepBS4xgjWV7vE3ElapVyMqq5Up7nLQ16P70lfgc1eqEZh91rnR3ZmZbLUgDG-uila-6WBD02qVf1Vpp5ovcNesJTLOmxfmw_XdQWYlYudj3lP5eW1rTDYj3I_ztVUU2PDcyhjMvV-q8qIR1bjTY2rGb_zBtW53gI8EUNqF84C5od8Wib5Rvzlm_b7v_cr3bjgxo1s1xnk92o3NoDSI3XiInb2iccaikFGG3u8Wue1zFmsPe_LtqMsKMO9rFQ5dS-wIOz7h7c7v2_RglOgsHpD79h8KzFqyHpKJKh-RuydWg_GYfN8FDDRg0AIGLWBgAANRwwAYjAGDvIQOMNCAQQcYbAMGPWCArMAYMBgAewcGL-jwAsQLBAx4wYAXGLyekMX8aPH-g2uXA3EvQu7hR8NQ5HNshsiiLE1ShcltIkOWUSGpSGWQMqp4GmEMCqlkIvUDwZj0mfIzvIc-JXslvvkzAjzjWSanCeZlKgj0BEiJiD3BE09NhVDJPnmtv_-5ZgHfSQpbqoJ369nSzgdj75ODrSvRN8vR6ed_Pv2C3BvgPiB7zfVavSR35E2T19eHpnvo0FD0E8Xyt58
linkProvider ISSN International Centre
openUrl ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=All-trans-retinoic+acid+versus+FOLFOX+alone+as+palliative+chemotherapy+in+patients+with+advanced+hepatocellular+carcinoma+and+extrahepatic+metastasis%3A+study+protocol+for+a+randomized+controlled+trial&rft.jtitle=Trials&rft.au=Shi%2C+Jie&rft.au=Sun%2C+Juxian&rft.au=Liu%2C+Chang&rft.au=Chai%2C+Zongtao&rft.date=2019-04-29&rft.pub=BioMed+Central+Ltd&rft.issn=1745-6215&rft.eissn=1745-6215&rft.volume=20&rft.issue=1&rft_id=info:doi/10.1186%2Fs13063-019-3349-9&rft.externalDocID=A586535870
thumbnail_l http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=1745-6215&client=summon
thumbnail_m http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=1745-6215&client=summon
thumbnail_s http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=1745-6215&client=summon