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

• Sponsor: The First Affiliated Hospital of Henan University of Science and Technology (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04648917
• Collaborator: (none)
• Enrollment: 80
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site: 26.7
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Esophagus Cancer, Stage III	Drug: Caffeic acid	Phase 3

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 1:1 Randomized grouping1:1 Randomized grouping
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: GASC1 Inhibitor Caffeic Acid for Advanced Squamous Esophageal Cell Cancer (ESCC): a Multicenter, Phase II Trial (GiCAEC)
• Actual Study Start Date: May 1, 2019
• Anticipated Primary Completion Date: May 1, 2021
• Anticipated Study Completion Date: May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A 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; 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)
Placebo Comparator: Arm B 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; 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)

Outcome Measures

Primary Outcome Measures

1. overall survival (OS) [1 year]

   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.

Secondary Outcome Measures

1. progression-free survival (PFS) [1 year]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Chinese

2. esophageal squamous cell cancer

3. stage IV or recurrence disease

4. chemotherapy, or radiotherapy, or palliative care is going on

Exclusion Criteria:

1. PS (performance status): ≥ 3

2. severe hepatic and renal dysfunction

3. hypercoagulability

4. thrombocytosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anyang Tumor Hospital	Anyang	Henan	China
2	The Clinical Medical College, The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan	China	471003
3	Nanyang Central Hospital	Nanyang	Henan	China	473000

Sponsors and Collaborators

• The First Affiliated Hospital of Henan University of Science and Technology

Investigators

• Study Chair: Shegan Gao, Ph.D, The Clinical Medical College, The First Affiliated Hospital of Henan Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The First Affiliated Hospital of Henan University of Science and Technology
• ClinicalTrials.gov Identifier: NCT04648917
• Other Study ID Numbers: GiCAEC-LY002
• First Posted: Dec 2, 2020
• Last Update Posted: Dec 3, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The First Affiliated Hospital of Henan University of Science and Technology: esophageal cancer; caffeic acid
• Additional relevant MeSH terms: Esophageal Neoplasms; Caffeic acid

Study Results

No Results Posted as of Dec 3, 2020