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Trial Title:
Toripalimab Plus Radiotherapy for Elderly Esophageal Cancer Patients Treated With Non-chemotherapy Strategy
NCT ID:
NCT05817201
Condition:
Esophageal Cancer
Radiation Therapy
Immunotherapy
Chemotherapy
Conditions: Official terms:
Esophageal Neoplasms
Tegafur
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Toripalimab 240mg day7 and day 28，every 3 weeks 1month after radiotherapy，until
progression or 1 years or intolerant.
Arm group label:
Toripalimab & Radiotherapy
Other name:
JS001
Other name:
TAB001
Intervention type:
Drug
Intervention name:
Tegafur
Description:
Tegafur 70mg/m2/day day 1 to day 14，and day 29 to day42.
Arm group label:
Chemotherapy & Radiotherapy
Other name:
S-1
Intervention type:
Radiation
Intervention name:
IMRT
Description:
PGTV 54Gy/2.16Gy/25F/5W, PTV 45Gy/1.8Gy/25F/5W
Arm group label:
Chemotherapy & Radiotherapy
Arm group label:
Toripalimab & Radiotherapy
Other name:
Irradiation
Other name:
intensity modulation radiation therapy
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Carcinoma of the esophagus confirmed histologically or cytologically. Lesions that can be
measured according to the RECIST standard. AJCC/UICC Staging of Esophageal Carcinoma
(Sixth Edition) Clinical Staging Ⅱa to Ⅲ.
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 chest radiation, chemotherapy, or surgical resection of esophageal cancer
before the start of this trial Patients with multifocal esophageal cancer, and the lower
boundary of the primary lesion of the esophagus is less than 3cm from the esophageal
gastric junction.
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.
Gender:
All
Minimum age:
70 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Haihua Yang
Address:
City:
Taizhou
Zip:
317000
Country:
China
Status:
Recruiting
Contact:
Last name:
Haihua Yang
Phone:
13819639006
Email:
yhh93181@hotmail.com
Investigator:
Last name:
Haihua Yang, MD
Email:
Principal Investigator
Investigator:
Last name:
Jian Zhu, MD
Email:
Sub-Investigator
Facility:
Name:
Taizhou Enze Medical Center(Group) Enze Hospital
Address:
City:
Taizhou
Zip:
318025
Country:
China
Status:
Recruiting
Contact:
Last name:
Haihua Yang
Phone:
13819639006
Email:
yhh93181@hotmail.com
Investigator:
Last name:
Haihua Yang, MD
Email:
Principal Investigator
Investigator:
Last name:
Chao Zhou, MD
Email:
Sub-Investigator
Start date:
July 1, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Taizhou Hospital
Agency class:
Other
Source:
Taizhou Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05817201
