An interventional study of Radiotherapy and Durvalumab in Esophageal Squamous Cell Carcinoma, sponsored by Chinese Academy of Medical Sciences. Status unknown at 1 site in China. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2021-06-22.
Sponsored by Chinese Academy of Medical Sciences · Not applicable, Interventional, and Treatment
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 33 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Chinese Academy of Medical Sciences is the lead sponsor of 235 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adequate bone marrow and organ function as defined below (excluding the use of any blood components and cell growth factors within 7 days):
Exclusion Criteria:
IMRT plus Durvalumab
Radiation: Radiotherapy · Drug: Durvalumab
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.
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: 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
Quality of Life (QOL): questionnaire EORTC QLQ-OES18
Evaluate the quality of life via questionnaire EORTC QLQ-OES18, minimum value 18, maximum value 72, higher scores mean a better outcome.
Time frame: up to 60 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chinese Academy of Medical Sciences