NCT04648917

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

GASC1 Inhibitor Caffeic Acid for Advanced Squamous Esophageal Cell Cancer (ESCC): a Multicenter, Phase II Trial (GiCAEC)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: The First Affiliated Hospital of Henan University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Esophagus Cancer, Stage III

Interventions

Type	Name	Description
DRUG	Caffeic acid	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)

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-05-01
• Completion: 2022-05-01
• First posted: 2020-12-02
• Last updated: 2020-12-03

Locations

3 sites across 1 country: China