NCT02976896

Apatinib for Esophageal Squamous Cell Cancer After the Failure of Standard Treatment

Efficacy and Safety of Apatinib Mesylate in Recurrent/Metastatic Esophageal Squamous Cell Carcinoma After the Failure of Conventional Treatment: a Phase II Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Yuhong Li · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

We conduct the phase II clinical trial to further explore the efficacy and safety of Apatinib Mesylate in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments. An exploratory molecular marker analysis will be performed in order to find out the beneficial population of Apatinib Mesylate.

Detailed description

Esophageal cancer is one of the most common malignant tumor in China. In Asian countries, esophageal squamous cell carcinoma is the main pathological type of esophageal carcinoma. Prognosis of esophageal squamous cell carcinoma is usually poor and surgery is the only radical treatment. Cisplatin (DDP, cisplatin), 5 - Fluorouracil (5 - Fluorouracil, 5 - FU) and taxane are the most adopted chemotherapy agents, with efficacy rates of 33%-40% as first-line treatment for metastatic or recurrent esophageal squamous carcinoma and a median overall survival of 6-10 months. New agents were needed. Apatinib Mesylate is a small molecule VEGFR tyrosine kinase inhibitor. The anti-tumor mechanism of Apatinib is inhibiting angiogenesis in malignancy by inhibiting VEGFR. Apatinib Mesylate was approved by CFDA (China Food and Drug Administration) for the treatment of advanced gastric cancer. In the previous clinical practice, we observed that part of the patients with esophageal squamous cell carcinoma were resistant to conventional treatments benefited from Apatinib Mesylate. Based on the research situation mentioned above, we decided to conduct a phase II clinical trial to further explore the efficacy and safety of Apatinib Mesylate in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments. An exploratory molecular marker analysis will be performed in order to find out the beneficial population of Apatinib Mesylate.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Apatinib Mesylate	Patients will receive Apatinib Mesylate at 500mg/times,oral one times daily for 28 days.

Timeline

• Start date: 2016-08-01
• Primary completion: 2019-12-01
• Completion: 2022-12-01
• First posted: 2016-11-29
• Last updated: 2023-02-16

Locations

1 site across 1 country: China