NCT03787251

A Study of Second-line Treatment of Postoperative Recurrence and Metastasis of Esophageal Cancer Treated With Apatinib

Randomized, Open, Positive Drug Control, Multicenter Clinical Study of Second-line Treatment of Postoperative Recurrence and Metastasis of Esophageal Squamous Cell Carcinoma With Chemotherapy in Patients Treated With Apatinib Mesylate

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A study of second-line treatment of postoperative recurrence and metastasis of esophageal squamous cell carcinoma after chemotherapy with apatinib mesylate

Detailed description

This is a randomized, open-label, multi-center, phase II clinical trial initiated by a investigator to observe and evaluate the efficacy of apatinib in the treatment of patients with failed first-line treatment after recurrence and metastasis of esophageal squamous cell carcinoma. Effectiveness and security.

Conditions

• Esophageal Neoplasms

Interventions

Type	Name	Description
DRUG	Apatinib	It is recommended that the initial dose of apatinib is 500mg po qd. Adjust the dose to 750mg po qd or maintain the original dose according to the patient's medication response for about 2 weeks. If there is grade III or above, or grade II and above non-hematologic toxicity, allow the dose to be lowered 2 times.
DRUG	The chemotherapeutic drug chosen by the investigator.	The choice of chemotherapy regimen is based on the medication habits of the drug delivery doctor and the specific circumstances of the patient. In addition, the following regimens may be selected as monotherapy or combination: docetaxel 60-75 mg/m2d1 q3w; irinotecan 150-180 mg/m2 d1 q2w until disease progression or patient death. If grade 3 and above or non-hematologic toxicity of grade II and above adverse event appeared, allowing the dose to be lowered twice.

Timeline

• Start date: 2019-01-01
• Primary completion: 2020-12-31
• Completion: 2021-12-31
• First posted: 2018-12-26
• Last updated: 2022-04-19