Clinical trial NCT03070262: The Efficacy and Safety of Caffeic Acid for Esophageal Cancer
Official title: Caffeic Acid for Advanced Esophageal Squamous Cell Cancer: A Randomized, Double-blind, and Multicenter Trial in Chinese Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Esophagus Cancer
Keywords: esophageal cancer
caffeic acid
Lead sponsor: The First Affiliated Hospital of Henan University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Anyang Tumor Hospital
name: 150th Hospital of PLA
First posted: 2017-03-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: overall survival (OS)
timeFrame: 1 year
Secondary outcomes:
measure: progression-free survival (PFS)
timeFrame: 1 year
Other outcomes:
Locations:
city: Luoyang
country: China
facility: The Clinical Medical College, The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
Study officials:
affiliation: The Clinical Medical College, The First Affiliated Hospital of Henan Science and Technology
name: Shegan Gao, PhD
role: STUDY_CHAIR
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