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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
200mg,d1,15,29,43,57,I.V
Capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total.
radiotherapy: 50-50.4Gy ,1.8-2 Gy/d,5d/w.
placebo: 200mg,d1,15,29,43,57,I.V
Grade 3/4 acute toxicities
rade 3/4 acute toxicities occurred during or within 90 days after CRT
Time frame: 90 days
PFS
Progression Free Survival After completion of the CRT
Time frame: 1 year
ORR
overall remission rate
Time frame: 16 weeks
OS Qol
overall survival
Time frame: 1 year
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