The Efficacy and Safety of Caffeic Acid for Esophageal Cancer (CAEC)

Henan University of Science and Technology

Status and phase: Unknown; Phase 3

Conditions: Esophagus Cancer

Treatments: Drug: CA; Drug: placebo group

Study type: Interventional

Funder types: Other

Identifiers

NCT03070262

GiCAEC-LY001

Details and patient eligibility

About

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).

Full 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

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups, including a placebo group

CA group

Experimental group

Description:

caffeic acid (300mg, tid, po) continue given until progression of disease or death, or patients are unable to bear the side effects

Treatment:

Drug: CA

placebo group

Placebo Comparator group

Description:

the same shape placebo tablets continue given until progression of disease or death, or patients are unable to bear the side effects

Treatment:

Drug: placebo group