Trials / Not Yet Recruiting
Not Yet RecruitingNCT05791136
Immunotherapy After Radiotherapy in Elderly ESCC
Toripalimab After Radiotherapy Alone in Elderly Esophageal Squamous Cell Carcinoma: A Prospective Phase II Clinical Trial
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- The Central Hospital of Lishui City · Academic / Other
- Sex
- All
- Age
- 75 Years
- Healthy volunteers
- Not accepted
Summary
The incidence and mortality of esophageal squamous cell carcinoma are at the forefront in China.Most part of patients are elderly. Concurrent chemoradiotherapy is the standard treatment for unresectable locally advanced esophageal squamous cell carcinoma. Most elderly patients 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 squamous cell carcinoma.
Detailed description
This is a prospective, multicenter, single-arm, phase Ⅱ clinical study to evaluate the efficacy and safety of radiotherapy alone followed by sequential injection of Toripalimab in elderly patients with unresectable esophageal squamous cell carcinoma who could not accept concurrent chemotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Radiotherapy | 95% PGTV56-60Gy/28-30 fractions, 2Gy/1 fractions; 95% PTV50.4-54Gy/28-30 fractions, 1.8Gy/1 fractions; 5 days a week; 6 weeks. |
| DRUG | Toripalimab | Toripalimab (200 mg, intravenously infused) will be administered as the maintenance treatment every 3 weeks within 4 weeks after the completion of radiotherapy for 1 years or until progression, intolerable toxicity, or physician/patient decision |
Timeline
- Start date
- 2023-04-01
- Primary completion
- 2024-04-30
- Completion
- 2026-06-30
- First posted
- 2023-03-30
- Last updated
- 2023-03-30
Source: ClinicalTrials.gov record NCT05791136. Inclusion in this directory is not an endorsement.