Safety and Efficacy of Neoadjuvant Immunochemotherapy in Elderly Patients With Resectable Esophageal Cancer
NCT06403878 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2024-05-08
Summary
We intend to conduct a prospective single-arm clinical study to explore the efficacy and safety of immunochemotherapy in neoadjuvant therapy in elderly patients with advanced esophageal squamous cell carcinoma. Most previous randomized controlled studies (such as the 5010 study) have excluded older patients ≥70 years of age. However, in the real world, elderly patients with esophageal cancer account for a large number of patients, and elderly people have many complications and poor tolerance to treatment, which limits the application of synchronous chemoradiotherapy in this group. There is no standard treatment plan for patients over 70 years old, and the purpose of this study is to explore the effectiveness and safety of neoadjuvant immunochemotherapy in the treatment of this group of elderly people.
Conditions
- Esophageal Cancer
Interventions
- DRUG
-
neoadjuvant chemotherapy,2cycles.
- DRUG
-
Nab paclitaxel
neoadjuvant chemotherapy,2cycles.
- DRUG
-
Sintilimab
neoadjuvant immunotherapy,2cycles.
Sponsors & Collaborators
-
Sichuan University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 70 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-31
- Primary Completion
- 2026-05-31
- Completion
- 2026-08-31
Countries
- China
Study Locations
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