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Safety and Efficacy of Neoadjuvant Immunochemotherapy in Elderly Patients With Resectable Esophageal Cancer - Trial NCT06403878

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NCT06403878
Phase 2
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06403878
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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.

Study Focus

Esophageal Cancer

Carboplatin

Interventional

drug

Sponsor & Location

Sichuan University

Chengdu, China

Timeline & Enrollment

Phase 2

May 01, 2024

Aug 01, 2026

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 โ‰ฅ70 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: Oesophagus
Malignant neoplasm of oesophagus
Malignant neoplasm: Middle third of oesophagus
Malignant neoplasm: Overlapping lesion of oesophagus
Malignant neoplasm: Upper third of oesophagus

Data Source

ClinicalTrials.gov

NCT06403878

Non-Device Trial