The Efficacy and Safety of Caffeic Acid for Esophageal Cancer

Phase 3

• Conditions: Esophagus Cancer
• Interventions: Drug: CA; Drug: placebo group

• Registration Number: NCT03070262
• 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: 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

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-02-28
• Study First Submitted QC: 2017-02-28
• Study First Posted: 2017-03-03
• Status Verified: 2020-04
• Last Update Submitted: 2020-11-24
• Last Update Posted: 2020-11-27
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CA group	CA	caffeic acid (300mg, tid, po) continue given until progression of disease or death, or patients are unable to bear the side effects
placebo group	placebo group	the same shape placebo tablets continue given until progression of disease or death, or patients are unable to bear the side effects

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 (1)

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