GASC1 Inhibitor Caffeic Acid for Squamous Esophageal Cell Cancer (ESCC) (GiCAEC)

Henan University of Science and Technology

Status and phase: Unknown; Phase 3

Conditions: Esophagus Cancer, Stage III

Treatments: Drug: Caffeic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04648917

GiCAEC-LY002

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: 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

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Arm A

Experimental group

Description:

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)

Treatment:

Drug: Caffeic acid

Arm B

Placebo Comparator group

Description:

In Arm B: 40 patients will receive the placebo tablets: 100-200mg, tid, po, 2 weeks treated then 1 week black interval.

Treatment:

Drug: Caffeic acid