The goal of this clinical trial is to explore the therapeutic efficacy of immune checkpoint inhibitors combined with radical radiotherapy in elderly patients with esophageal cancer.
Older patients with esophageal cancer are universally intolerant to chemotherapy. This study is performed to explore a non-chemotherapy strategy for elderly esophageal cancer patients. Participants will be treated with Toripalimab monoclonal antibody maintenance versus S-1 combined with radiotherapy, intended to explore the efficacy and safety of non-chemotherapy strategy for elderly esophageal cancer patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Toripalimab 240mg day7 and day 28,every 3 weeks 1month after radiotherapy,until progression or 1 years or intolerant.
Tegafur 70mg/m2/day day 1 to day 14,and day 29 to day42.
PGTV 54Gy/2.16Gy/25F/5W, PTV 45Gy/1.8Gy/25F/5W
Haihua Yang
Taizhou, Zhejiang, China
RECRUITINGTaizhou Enze Medical Center(Group) Enze Hospital
Taizhou, Zhejiang, China
RECRUITINGOverall survival
The OS was defined as the duration from the date of of initiation of treatment to the date of death from any cause or censored at the date of the last follow-up.
Time frame: Time Frame: 2 years
Progression-Free survival
Progression-free survival (PFS) will be calculated from the date of initiation of treatment until the day of documented failure (local recurrence or metastasis occurrence) or until the date of the last follow-up visit.
Time frame: Time Frame: 2 years
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