Toripalimab Plus Radiotherapy for Elderly Esophageal Cancer Patients Treated With Non-chemotherapy Strategy
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
Drug: Toripalimab
Toripalimab 240mg day7 and day 28，every 3 weeks 1month after radiotherapy，until progression or 1 years or intolerant.
Other Names:
Radiation: IMRT
PGTV 54Gy/2.16Gy/25F/5W, PTV 45Gy/1.8Gy/25F/5W
Other Names:
|
| Active Comparator: Chemotherapy & Radiotherapy Tegafur, 70mg/m2/d, radiotherapy D1-14, D29-42; Thoracic radiotherapy, 54Gy/25F, IMRT. |
Drug: Tegafur
Tegafur 70mg/m2/day day 1 to day 14，and day 29 to day42.
Other Names:
Radiation: IMRT
PGTV 54Gy/2.16Gy/25F/5W, PTV 45Gy/1.8Gy/25F/5W
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall survival [Time Frame: 2 years]
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.
Secondary Outcome Measures
- Progression-Free survival [Time Frame: 2 years]
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.
Eligibility Criteria
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 * 109/L, absolute neutrophil count ≥ 1.5 * 109/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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Haihua Yang | Taizhou | Zhejiang | China | 317000 |
| 2 | Taizhou Enze Medical Center(Group) Enze Hospital | Taizhou | Zhejiang | China | 318025 |
Sponsors and Collaborators
- Taizhou Hospital
Investigators
- Principal Investigator: Taizhou Enze Medical Center(Group) Enze Hospital Yang, MD, Taizhou Enze Medical Center (Group) Enze Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TREEN Trial