Toripalimab Plus Radiotherapy for Elderly Esophageal Cancer Patients Treated With Non-chemotherapy Strategy
NCT ID: NCT05817201
Last Updated: 2023-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2022-07-01
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Toripalimab & Radiotherapy
Toripalimab, 240mg/d, radiotherapy D7, D28; Thoracic radiotherapy, 54Gy/25F, IMRT; Maintenance Toripalimab therapy after completed radiotherapy, 240mg/Q3W, until progression or 1 years or intolerant
Toripalimab
Toripalimab 240mg day7 and day 28，every 3 weeks 1month after radiotherapy，until progression or 1 years or intolerant.
IMRT
PGTV 54Gy/2.16Gy/25F/5W, PTV 45Gy/1.8Gy/25F/5W
Chemotherapy & Radiotherapy
Tegafur, 70mg/m2/d, radiotherapy D1-14, D29-42; Thoracic radiotherapy, 54Gy/25F, IMRT.
Tegafur
Tegafur 70mg/m2/day day 1 to day 14，and day 29 to day42.
IMRT
PGTV 54Gy/2.16Gy/25F/5W, PTV 45Gy/1.8Gy/25F/5W
Interventions
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Toripalimab
Toripalimab 240mg day7 and day 28，every 3 weeks 1month after radiotherapy，until progression or 1 years or intolerant.
Tegafur
Tegafur 70mg/m2/day day 1 to day 14，and day 29 to day42.
IMRT
PGTV 54Gy/2.16Gy/25F/5W, PTV 45Gy/1.8Gy/25F/5W
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Age ≥ 70 years ≤ 85 years old. The ECOG physical state score is 0 to 1. No esophageal perforation, active esophageal bleeding, or significant invasion of trachea or thoracic aorta.
Patients with not previously received chest radiation and speech therapy, immunotherapy, or biological therapy.
Hemoglobin ≥ 100g/L, platelets ≥ 100 \* 10\^9/L, absolute neutrophil count ≥ 1.5 \* 10\^9/L。 Serum creatinine ≤ 1.25 times UNL or creatinine clearance ≥ 60 mL/min. Serum bilirubin ≤ 1.5 times UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 times UNL, and alkaline phosphatase ≤ 5 times UNL.
No history of interstitial pneumonia or previous interstitial pneumonia. FEV1\>0.8L。
The patient signs a formal informed consent form.
Exclusion Criteria
Patients with severe cardiovascular or pulmonary disease, interstitial pneumonia, or a previous history of interstitial pneumonia.
Patients with obvious esophageal ulcer, moderate or above pain in chest and back, and symptoms of esophageal perforation.
Patients who cannot understand or may not comply with the test requirements. Patients with other malignant lesions, except for curable skin cancer (non melanoma), cervical carcinoma in situ or malignant disease that has been cured for ≥ 5 years.
Researchers believe that some obvious diseases should be excluded from this study.
70 Years
85 Years
ALL
No
Sponsors
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Taizhou Hospital
OTHER
Responsible Party
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Haihua Yang
Head of Department of Radiation Oncology
Principal Investigators
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Taizhou Enze Medical Center(Group) Enze Hospital Yang, MD
Role: PRINCIPAL_INVESTIGATOR
Taizhou Enze Medical Center Group
Locations
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Haihua Yang
Taizhou, Zhejiang, China
Taizhou Enze Medical Center(Group) Enze Hospital
Taizhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TREEN Trial
Identifier Type: -
Identifier Source: org_study_id
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