Clinical trial NCT04648917: GASC1 Inhibitor Caffeic Acid for Squamous Esophageal Cell Cancer (ESCC)
Official title: GASC1 Inhibitor Caffeic Acid for Advanced Squamous Esophageal Cell Cancer (ESCC): a Multicenter, Phase II Trial (GiCAEC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Esophagus Cancer, Stage III
Keywords: esophageal cancer
caffeic acid
Lead sponsor: The First Affiliated Hospital of Henan University of Science and Technology
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 Randomized grouping
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: 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

Eligibility criteria: 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

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