NCT03251417

Apatinib and Irinotecan Combination Treatment in Unresectable or Metastatic Esophageal Squamous Cell Carcinoma

Apatinib and Irinotecan Combination Treatment in Unresectable or Metastatic Esophageal Squamous Cell Carcinoma Patients Failed in First-line Chemotherapy: A Phase II Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Esophageal cancer is a common malignant disease worldwide especially in china. Though esophagectomy and definitive chemoradiotherapy are standard treatments, disease relapses in many patients and the prognosis of metastatic ESCC is still poor. For patients with unresectable or metastatic ESCC, chemotherapy is an important treatment alone or with radiotherapy. Taxane, platinum, and fluoropyrimidine have been reported effective in ESCC and is used as first-line treatment of ESCC. As for 2nd-line treatment, both irinotecan and taxane had been recommended based on data from clinical trials which were most enrolled esophageal or esophageal-gastric junction adenocarcinoma and with only small sample size. Therefore, it is still urgently needed to explore effective 2nd-line treatment for ESCC. Apatinib, also known as YN968D1, is an orally antiangiogenic agents. Preclinical and clinical data had shown that it is effective in the treatment of a variety of solid tumors including esophageal cancer. It had been approved as a 3rd-line treatment for patients with advanced gastric cancer by state FDA of China in 2014. And the safety data showed that hemorrhage is rare and non-fetal which is different from bevacizumab. Therefore, the investigators initialize this phase II study to explore the efficacy and safety of irinotecan and apatinib combination treatment in unresectable or metastatic ESCC patients who failed in 1st-line chemotherapy or chemoradiotherapy.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Irinotecan	Irinotecan 150mg/m2, repeated very 2 weeks for 3 to 6 cycles.
DRUG	Apatinib	Apatinib 500 mg oral take, daily

Timeline

• Start date: 2017-09-10
• Primary completion: 2021-04-25
• Completion: 2021-04-25
• First posted: 2017-08-16
• Last updated: 2023-02-01

Locations

1 site across 1 country: China