NCT06403878

Safety and Efficacy of Neoadjuvant Immunochemotherapy in Elderly Patients With Resectable Esophageal Cancer

Prospective, Single-arm, Phase II Study of Nab-paclitaxel Plus Carboplatin in Combination With Sintilimab for Neoadjuvant Therapy in Elderly, Locally Advanced, Resectable Esophageal Squamous Cell Carcinoma.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Sichuan University · Academic / Other
• Sex: All
• Age: 70 Years – 100 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Carboplatin	neoadjuvant chemotherapy，2cycles.
DRUG	Nab paclitaxel	neoadjuvant chemotherapy，2cycles.
DRUG	Sintilimab	neoadjuvant immunotherapy，2cycles.

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-05-01
• Completion: 2026-08-01
• First posted: 2024-05-08
• Last updated: 2024-05-08

Locations

1 site across 1 country: China