NCT04648917

Brief Summary

Caffeic acid can target inhibit GASC1 (gene amplified in squamous cell carcinoma 1, also known as KDM4C and JMJD2C) expression and GASC1 is confirmed to be a new oncogene in several cancers including esophageal cancer. This study aims to investigate the efficiency and safety of coffeic acid in chinese advanced esophageal squamous cell cancer (ESCC).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2019

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

December 3, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

November 24, 2020

Last Update Submit

December 1, 2020

Conditions

Esophagus Cancer, Stage III

Keywords

esophageal cancercaffeic acid

Outcome Measures

Primary Outcomes (1)

  • overall survival (OS)

    The percentage of 1 year overall survival (OS) after random allocation. The follow-up will be done every 3 months through phone call, investigator visiting, and medical recording review.

    1 year

Secondary Outcomes (1)

  • progression-free survival (PFS)

    1 year

Study Arms (2)

Arm A

EXPERIMENTAL

In Arm A: 40 patients will receive coffeic acid treatment: 100-200mg, tid, po, 2 weeks treated then 1 week black interval (weight \>50kg, 200mg per time, weight \< or =50kg, 100mg per time)

Drug: Caffeic acid

Arm B

PLACEBO COMPARATOR

In Arm B: 40 patients will receive the placebo tablets: 100-200mg, tid, po, 2 weeks treated then 1 week black interval.

Drug: Caffeic acid

Interventions

Caffeic acidDRUG

40 patients will receive coffeic acid treatment: 100-200mg, tid, po, 2 weeks treated then 1 week black interval(weight \>50kg, 200mg per time, weight \< or =50kg, 100mg per time)

Arm AArm B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chinese
  • esophageal squamous cell cancer
  • stage IV or recurrence disease
  • chemotherapy, or radiotherapy, or palliative care is going on

You may not qualify if:

  • PS (performance status): ≥ 3
  • severe hepatic and renal dysfunction
  • hypercoagulability
  • thrombocytosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Anyang Tumor Hospital

Anyang, Henan, China

RECRUITING

The Clinical Medical College, The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471003, China

RECRUITING

Nanyang Central Hospital

Nanyang, Henan, 473000, China

RECRUITING

Related Publications (11)

  • Pedersen MT, Kooistra SM, Radzisheuskaya A, Laugesen A, Johansen JV, Hayward DG, Nilsson J, Agger K, Helin K. Continual removal of H3K9 promoter methylation by Jmjd2 demethylases is vital for ESC self-renewal and early development. EMBO J. 2016 Jul 15;35(14):1550-64. doi: 10.15252/embj.201593317. Epub 2016 Jun 6.

    PMID: 27266524RESULT

  • Movassaghian S, Xie Y, Hildebrandt C, Rosati R, Li Y, Kim NH, Conti DS, da Rocha SR, Yang ZQ, Merkel OM. Post-Transcriptional Regulation of the GASC1 Oncogene with Active Tumor-Targeted siRNA-Nanoparticles. Mol Pharm. 2016 Aug 1;13(8):2605-21. doi: 10.1021/acs.molpharmaceut.5b00948. Epub 2016 Jun 27.

    PMID: 27223606RESULT

  • Sudo G, Kagawa T, Kokubu Y, Inazawa J, Taga T. Increase in GFAP-positive astrocytes in histone demethylase GASC1/KDM4C/JMJD2C hypomorphic mutant mice. Genes Cells. 2016 Mar;21(3):218-25. doi: 10.1111/gtc.12331. Epub 2016 Jan 25.

    PMID: 26805559RESULT

  • Jia R, Yang L, Yuan X, Kong J, Liu Y, Yin W, Gao S, Zhang Y. GASC1 Promotes Stemness of Esophageal Squamous Cell Carcinoma via NOTCH1 Promoter Demethylation. J Oncol. 2019 Mar 26;2019:1621054. doi: 10.1155/2019/1621054. eCollection 2019.

    PMID: 31031809RESULT

  • Uimonen K, Merikallio H, Paakko P, Harju T, Mannermaa A, Palvimo J, Kosma VM, Soini Y. GASC1 expression in lung carcinoma is associated with smoking and prognosis of squamous cell carcinoma. Histol Histopathol. 2014 Jun;29(6):797-804. doi: 10.14670/HH-29.797. Epub 2013 Dec 27.

    PMID: 24371038RESULT

  • Sun LL, Holowatyj A, Xu XE, Wu JY, Wu ZY, Shen JH, Wang SH, Li EM, Yang ZQ, Xu LY. Histone demethylase GASC1, a potential prognostic and predictive marker in esophageal squamous cell carcinoma. Am J Cancer Res. 2013 Nov 1;3(5):509-17. eCollection 2013.

    PMID: 24224128RESULT

  • Berdel B, Nieminen K, Soini Y, Tengstrom M, Malinen M, Kosma VM, Palvimo JJ, Mannermaa A. Histone demethylase GASC1--a potential prognostic and predictive marker in invasive breast cancer. BMC Cancer. 2012 Nov 14;12:516. doi: 10.1186/1471-2407-12-516.

    PMID: 23148692RESULT

  • Jia R, Mi Y, Yuan X, Kong D, Li W, Li R, Wang B, Zhu Y, Kong J, Ma Z, Li N, Mi Q, Gao S. GASC1-Adapted Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma: A Prospective Clinical Biomarker Trial. J Oncol. 2020 Jan 30;2020:1607860. doi: 10.1155/2020/1607860. eCollection 2020.

    PMID: 32411232RESULT

  • Yang ZQ, Imoto I, Fukuda Y, Pimkhaokham A, Shimada Y, Imamura M, Sugano S, Nakamura Y, Inazawa J. Identification of a novel gene, GASC1, within an amplicon at 9p23-24 frequently detected in esophageal cancer cell lines. Cancer Res. 2000 Sep 1;60(17):4735-9.

    PMID: 10987278RESULT

  • Cederblad L, Thunberg U, Engstrom M, Castro J, Rutqvist LE, Laytragoon-Lewin N. The combined effects of single-nucleotide polymorphisms, tobacco products, and ethanol on normal resting blood mononuclear cells. Nicotine Tob Res. 2013 May;15(5):890-5. doi: 10.1093/ntr/nts207. Epub 2012 Oct 4.

    PMID: 23042982RESULT

  • Yuan X, Kong J, Ma Z, Li N, Jia R, Liu Y, Zhou F, Zhan Q, Liu G, Gao S. KDM4C, a H3K9me3 Histone Demethylase, is Involved in the Maintenance of Human ESCC-Initiating Cells by Epigenetically Enhancing SOX2 Expression. Neoplasia. 2016 Oct;18(10):594-609. doi: 10.1016/j.neo.2016.08.005. Epub 2016 Sep 19.

    PMID: 27742014RESULT

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

caffeic acid

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Shegan Gao, Ph.D

    The Clinical Medical College, The First Affiliated Hospital of Henan Science and Technology

    STUDY CHAIR

Central Study Contacts

Shegan Gao, Ph.D

CONTACT

+86 18638859977gsg112258@163.com

Ruinuo Jia, Ph.D

CONTACT

+86 18537950766jiaruinuo@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1 Randomized grouping
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2020

First Posted

December 2, 2020

Study Start

May 1, 2019

Primary Completion

May 1, 2021

Study Completion

May 1, 2022

Last Updated

December 3, 2020

Record last verified: 2020-11

Locations

CN(3)