The purpose of this study is to observe and evaluate the efficacy and safety of Sintilimab for Consolidation Therapy After Radical Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
In China, the incidence of esophageal cancer has declined in recent years, but the mortality rate has been ranked fourth. Morbidity and mortality were ranked sixth and fourth in all malignancies, respectively. Therefore, esophageal cancer has always been a major malignant tumor that threatens the health of our residents.We designed a single-arm, open-label, phase II trial of Sintilimab for consolidation therapy after radical concurrent chemoradiotherapylocally advanced esophageal squamous cell carcinoma.The purpose of this study is to observe and evaluate the efficacy and safety of Sintilimab for consolidation therapy after radical concurrent chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
The first stage:concurrent chemoradiotherapy,cisplatin,25-30mg/m2 ivgtt d1;capecitabine,800mg/m2, bid d1-5,qw,5weeks;concurrent radiotherapy,1.8-2Gy/d,5d/W,50-50.4Gy. second stage:Sintilimab, 200mg,q3w, a total of 3 times,Each infusion lasted for 30-60 min until disease progression or intolerable toxicity, with a maximum duration of no more than 12 months.
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Progression-free survival(PFS)
Evaluation of anti-PD-1 antibody Sintilimab for progression-free survival in patients with locally advanced unresectable esophageal squamous cell carcinoma who did not develop disease after radical concurrent chemoradiotherapy
Time frame: up to 1 year
Objective Response Rate,ORR
To evaluate the objective response rate (objective response rate, ORR) of Sintilimab in patients with locally advanced esophageal squamous cell carcinoma who have not progressed after concurrent radiotherapy and chemotherapy
Time frame: At time of surgery
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