The Efficacy and Safety of Caffeic Acid for Esophageal Cancer

Study Overview
=================
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: 240 advanced ESCC patients will be randomized to two arms: Arm A (receiving coffeic acid treatment) or Arm B (placebo group). In Arm A, patients will receive coffeic acid treatment: 300mg, tid, po, continue to progress disease (PD) or die or the intolerant adverse events; in Arm B, the same shape placebo tablets will be deliveried to patients. 1 years follow-up for both groups patients.Patients in both arms can receive any other ways of anti cancer therapy in the same time. Primary endpoints: OS Second endpoints: PFS

Official Title
-----------------
Caffeic Acid for Advanced Esophageal Squamous Cell Cancer: A Randomized, Double-blind, and Multicenter Trial in Chinese Patients

Conditions
-----------------
Esophagus Cancer

Intervention / Treatment
-----------------
* Drug: CA
* Drug: placebo group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chinese esophageal squamous cell cancer stage IV or disease recurrence chemotherapy, or radiotherapy, or palliative care is going on Exclusion Criteria: PS (performance status): ≥ 3 severe hepatic and renal dysfunction hypercoagulability thrombocytosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CA group<br>caffeic acid (300mg, tid, po) continue given until progression of disease or death, or patients are unable to bear the side effects | Drug: CA<br>* caffeic acid, 300mg, tid, po<br>|
| Placebo Comparator: placebo group<br>the same shape placebo tablets continue given until progression of disease or death, or patients are unable to bear the side effects | Drug: placebo group<br>* placebo tablet, 3 tablets, tid, po<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
caffeic acid, esophageal cancer