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

Phase 3

• Conditions: Esophagus Cancer, Stage III
• Interventions: Drug: Caffeic acid

• Registration Number: NCT04648917
• Lead Sponsor: The First Affiliated Hospital of Henan University of Science and Technology

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).

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 Timeline

• Study Start: 2019-05-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-11-24
• Last Update Submitted: 2020-12-01
• Study First Posted: 2020-12-02
• Last Update Posted: 2020-12-03
• Primary Completion: 2021-05-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Caffeic acid	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)
Arm B	Caffeic acid	In Arm B: 40 patients will receive the placebo tablets: 100-200mg, tid, po, 2 weeks treated then 1 week black interval.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (3)

Nanyang Central Hospital; 🇨🇳 Nanyang, Henan, China

Anyang Tumor Hospital; 🇨🇳 Anyang, Henan, China

The Clinical Medical College, The First Affiliated Hospital of Henan University of Science and Technology; 🇨🇳 Luoyang, Henan, China