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NCT06403878Recruiting

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.
Sichuan UniversityPhase 2ClinicalTrials.govdrug
Study focus
Disease/Condition
Esophageal Cancer
Drug/Device/Intervention
Carboplatin
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Sichuan University
Location
Chengdu, China
Timeline & enrollment
Phase
Phase 2
Start date
May 01, 2024
End date
Aug 01, 2026
Enrollment
68 participants
Primary outcome

Pathological complete response rate

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.

ICD-10 classifications
Carcinoma in situ: OesophagusMalignant neoplasm of oesophagusMalignant neoplasm: Middle third of oesophagusMalignant neoplasm: Overlapping lesion of oesophagusMalignant neoplasm: Upper third of oesophagus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06403878
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06403878 through Pure Global AI's free database. This Phase 2 trial is sponsored by Sichuan University and is currently Recruiting. The study focuses on Esophageal Cancer. Target enrollment is 68 participants.

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