Apatinib in the Treatment of Recurrence or Metastasis of Esophageal Cancer

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title: Prospective,Single-arm,and Exploratory Phase II Clinical Study for the Efficacy of Apatinib in the Treatment of Recurrence or Metastasis of Esophageal Squamous Cell Carcinoma After Radical Resection

Status Recruiting

Clinical Trial Summary

It was difficult to obtain clinical benefits through traditional chemotherapy and radiotherapy for the patients who have recurrence or metastasis tumor even though they have received first-line chemotherapy or combined radiotherapy before, but failed.The aim of this study was to evaluate the safety and efficacy of apatinib, an anti-angiogenesis drug, in the treatment of patients with advanced esophageal squamous cell carcinoma who had recurrence or metastasis after radical resection

Clinical Trial Description

Esophageal cancer is a common malignant tumor in China and its prognosis is poor. Its main treatment methods include surgery, radiotherapy and chemotherapy. However, the 5-year survival rate of esophageal cancer after operation is only about 40%. The main cause of treatment failure is postoperative recurrence and metastasis.The 2-year recurrence rate of esophageal cancer after radical operation was 50%, the median recurrence time was about 10 months and the 2-year survival rate was less than 15% for these patients.For patients with local recurrence, endoscopic submucosal resection, salvage resection and radiotherapy could be chosen. Palliative chemotherapy is another important method for patients with recurrence or metastasis who are not suitable for surgery or radiotherapy.Cisplatin combined with fluorouracil is a usually used first-line chemotherapy regimen, but the response rate is less than 30% and the median survival time is only about 6~10 months.There is no standard second-line treatment for patients who have failed first-line treatment. Over the past decade, the second-line treatment for esophageal cancer is mostly phase I and II studies. The reported objective remission rate(ORR) ranges from 2.8% to 45%, the median progression-free survival (PFS) ranges from 1.2 to 5.2 months and the median overall survival (OS) ranges from 3.7 to 11.4 months.Although some studies have shown that taxus-based second-line chemotherapy can bring a certain degree of remission to patients, irinotecan, gemcitabine and oxaliplatin can also be used as the second-line chemotherapy options for these patients, but the overall efficiency is low and disease progression occurs quickly.The median survival time of esophageal stent, nasal feeding nutrition support and gastrostomy is only 6 months, and the 1-year survival rate is generally less than 5%.The previous treatment options are few and the therapeutic effect is poor for the patients with locally advanced esophageal cancer who have received neoadjuvant chemotherapy combined with or without radiotherapy and adjuvant chemotherapy combined with or without radiotherapy after radical resection and those patients with persistent or new occurred recurrence and metastasis. At present, there is no consensus on the second-line treatment strategy for recurrent and metastasis esophageal squamous cell carcinoma after radical resection and there are various clinical options.Therefore, it is of great clinical significance to explore the second-line treatment strategy for these patients.

In recent years, with the development of molecular targeted therapy, it has been applied to the treatment of esophageal cancer, which is not only expected to ensure clinical efficacy, but also to reduce the adverse effects of amount of traditional chemotherapy and radiotherapy.At present, research on targeted therapy for esophageal cancer is gradually increasing. Targeted therapeutic drugs mainly include epidermal growth factor receptor(EGFR) inhibitors,vascular endothelial growth factor(VEGF) inhibitors, monoclonal antibodies, cyclooxygenase(COX) inhibitors and so on.Studies have confirmed that VEGF is highly expressed in the development of various malignant tumors including esophageal cancer, which may be closely related to tumor invasion and metastasis.As a VEGFR tyrosine kinase inhibitor, apatinib mainly treats malignant tumors by inhibiting VEGFR to exert anti-angiogenic effects.Previous studies have confirmed that apatinib was safe and effective in the treatment of advanced gastric cancer and adenocarcinoma of the gastroesophageal junction which was approved by China food and drug administration(CFDA).

In summary, it was difficult to obtain clinical benefits through traditional chemotherapy and radiotherapy for the patients who have recurrence or metastasis tumor even though they have received first-line chemotherapy or combined radiotherapy before, but failed.The aim of this study was to evaluate the safety and efficacy of apatinib, an anti-angiogenesis drug, in the treatment of patients with advanced esophageal squamous cell carcinoma who had recurrence or metastasis after radical resection. ;

Related Conditions & MeSH terms

• Apatinib
• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma
• Metastasis
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Recurrence

• NCT number: NCT03913182
• Study type: Interventional
• Source: Shanghai Chest Hospital
• Contact: Zhigang Li
• Phone: 86-021-62181990
• Email: dr_lizhigang@163.com
• Status: Recruiting
• Phase: Phase 2
• Start date: April 2, 2019
• Completion date: May 30, 2021