The incidence and mortality of esophageal cancer are at the forefront in China, among which the elderly patients account for a large proportion. Concurrent chemoradiotherapy is the standard treatment for inoperable locally advanced esophageal cancer. Most elderly patients with esophageal cancer cannot tolerate concurrent chemotherapy because of complications and other reasons. Immunotherapy has definite efficacy and low toxicity in advanced esophageal squamous cell carcinoma, and the results combined with radiotherapy have also been preliminarily reported. Therefore, it is necessary to further explore the efficacy and safety of radiotherapy combined with immunotherapy in elderly patients with esophageal cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
IMRT (Intensity Modulated RT) or 3D-CRT (three-dimensional conformal radiotherapy); 95% PGTV 59.92Gy/2.14Gy/28f; 95% GTVnd 59.92Gy/2.14Gy/28f; 95% PTV 50.40Gy/1.80Gy/28f; 5 days a week; 6 weeks.
Durvalumab 1000 mg, intravenously (IV), on Day 1 of radiotherapy, every 3 weeks for up to 18 administrations.
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
RECRUITINGProgression-free survival (PFS)
PFS was assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1. Progression-free survival defined as the time from enrollment to the first documented disease progression of local recurrence or distant metastasis or death due to any cause.
Time frame: 1-year
Overall survival (OS)
Overall survival defined as the time from enrollment to death due to any cause.
Time frame: 1-, 2- and 3-year
Progression-free survival (PFS)
PFS was assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1. Progression-free survival defined as the time from enrollment to the first documented disease progression of local recurrence or distant metastasis or death due to any cause.
Time frame: 2- and 3-year
Objective Response Rate (ORR)
ORR was Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Time frame: during the intervention up to 60 weeks
Disease Control Rate (DCR)
DCR was Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Time frame: during the intervention up to 60 weeks
Number of participants with an adverse event
Evaluanted by CTCAE 5.0
Time frame: Up to 60 weeks
Quality of Life (QOL): questionnaire EORTC QLQ-C30 (version 3)
Evaluate the quality of life via questionnaire EORTC QLQ-C30 (version 3), minimum value 30, maximum value 126, higher scores mean a worse outcome.
Time frame: up to 60 weeks
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