NCT04404491

Clinical Control Study of Immunotherapy and Concurrent Chemoradiotherapy in Patients With Esophageal Cancer Recurrence

The Third Phase of Immunotherapy and Concurrent Chemoradiotherapy in Patients With Esophageal Cancer Recurrence Was Compared With the Clinical Comparison

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: The First Affiliated Hospital of Henan University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Esophageal cancer is still a serious threat to human life and health. China in particular. Relapse and metastasis are important causes of treatment failure. Immunotherapy is a new treatment method, which can be used in combination with chemotherapy to improve the therapeutic effect. However, the role of immunotherapy combined with chemoradiotherapy in concurrent chemoradiotherapy of recurrent esophageal cancer has not been clearly studied. Our team will study it in detail. The purpose of this study was to compare and analyze the effect of Camrelizumab in concurrent chemoradiotherapy of locally recurrent esophageal cancer.

Detailed description

In this study, patients with local recurrence of esophageal carcinoma without distant metastasis were randomly divided into experimental group and control group by Block randomization. In the experimental group, patients with local recurrence were treated with Camrelizumab combined with concurrent chemoradiotherapy. Followed up for 3 years to observe the objective remission rate and disease-free survival. In the control group, patients with local recurrence were treated with placebo combined with concurrent chemoradiotherapy. Followed up for 3 years to observe the objective remission rate and disease-free survival.

Conditions

• Esophageal Malignant Neoplasm, Local Recurrence

Interventions

Type	Name	Description
DRUG	Procedural death 1	200mg,d1,15,29,43,57,I.V
DRUG	Capecitabine	Capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total.
RADIATION	Radiotherapy	radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.
DRUG	Placebo	placebo: 200mg,d1,15,29,43,57,I.V

Timeline

• Start date: 2020-06-01
• Primary completion: 2022-12-30
• Completion: 2023-06-30
• First posted: 2020-05-27
• Last updated: 2020-05-27