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Esophagus Cancer, Stage IIIPhase 3GiCAECNCT04648917

GASC1 Inhibitor Caffeic Acid for Squamous Esophageal Cell Cancer (ESCC)

A Phase 3 study testing Caffeic acid in people with Esophagus Cancer, Stage III, run by The First Affiliated Hospital of Henan University of Science and Technology at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophagus Cancer, Stage III
What is being tested?
Caffeic acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
3 sitesChina
Study dates
1 May 2019to 1 May 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Shegan Gao, Ph.D contact

+86 18638859977

gsg112258@163.com

Ruinuo Jia, Ph.D contact

+86 18537950766

jiaruinuo@163.com

China3 sites, 3 recruiting

  • Anyang Tumor Hospital

    Anyang, Henan

    Fuyou Zhou, MD,PhD, +86 13939998799, jiaruinuo@163.com

    Recruiting

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

    Luoyang, Henan, 471003

    Shegan Gao, PhD, 0379 64811906, gsg112258@163.com

    Ruinuo Jia, MD, 0379 64815350, jiaruinuo@163.com

    Recruiting

  • Nanyang Central Hospital

    Nanyang, Henan, 473000

    Lixin Wan, MD

    Recruiting

Other trials in China

About this study

Official title: GASC1 Inhibitor Caffeic Acid for Advanced Squamous Esophageal Cell Cancer (ESCC): a Multicenter, Phase II Trial (GiCAEC)

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).

Read the detailed description

Background: More than half of global esophageal cancer cases came from China.80 percentage patients were diagnosed with advanced disease and suffered from the poor outcome.With the development of target therapy among cancers,the overall survival and life quality of patients has been continuous improved recently.However,there had little reports focusing on target therapy in esophageal cancer . Caffeic acid as an ordinary drug is used for thrombocytopenia when patient received chemotherapy. Newly studies shown caffeic acid can target inhibit GASC1 expression, and GASC1 is confirmed to be a new oncogene in esophageal cancer.

Aim: to investigate the efficiency and safety of caffeic acid in chinese advanced esophageal squamous cell cancer.

Methods: 80 advanced ESCC patients who failed to the chemotherapy or chemoradiotherapy (1 or 2 line) will be randomized to two arms: arm A and arm B. 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; in arm B, 40 patients will receive the placebo tablets. 1 years follow-up for all patients in this trial. Patients in both arms can receive any other ways of anti cancer therapy in the same time.

Primary endpoints: OS; Second endpoints: PFS

Being tested
Caffeic acid
Keywords
esophageal cancer, caffeic acid
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

Study groups in NCT04648917
Study groupRoleWhat they receive
Arm AExperimentalIn 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)
Receives: Drug: Caffeic acid
Arm BPlacebo comparatorIn Arm B: 40 patients will receive the placebo tablets: 100-200mg, tid, po, 2 weeks treated then 1 week black interval.
Receives: Drug: Caffeic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (1)

  1. progression-free survival (PFS)

    The percentage of 3 months progression-free survival (PFS) after random allocation. PFS was defined as the time from randomisation to disease progression or death as assessed by the treating physicians in the study through CT scan, gastroscopy and biopsy pathology, X-ray barium meal.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2020
  2. Study start1 May 2019
  3. Primary completion1 May 2021 (estimated)
  4. Study completion1 May 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 Randomized grouping
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04648917
Sponsor's protocol ID
GiCAEC-LY002
Acronym
GiCAEC
Status last verified
Nov 2020
First submitted
24 Nov 2020
Last updated
3 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 27266524

  • 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.

    PubMed 27223606

  • 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.

    PubMed 26805559

  • 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.

    PubMed 31031809

  • 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.

    PubMed 24371038

  • 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.

    PubMed 24224128

  • 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.

    PubMed 23148692

  • 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.

    PubMed 32411232

  • 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.

    PubMed 10987278

  • 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.

    PubMed 23042982

  • 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.

    PubMed 27742014

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Caffeic acid in people with Esophagus Cancer, Stage III, run by The First Affiliated Hospital of Henan University of Science and Technology at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shegan Gao, Ph.D (+86 18638859977, gsg112258@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (OS) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04648917, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.

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