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RECRUITING
NCT06354530
PHASE2/PHASE3

A Study of Neoadjuvant Therapy for the Treatment of Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

Sponsor: Army Medical Center of PLA

View on ClinicalTrials.gov

Summary

The goal of this interventional study is to compare the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma. The main question it aims to answer is: To evaluate the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma and to explore the optimal preoperative neoadjuvant treatment regimen for esophageal squamous cell carcinoma.

Official title: Neoadjuvant Immunotherapy Plus Chemotherapy and Anlotinib Versus Immunotherapy Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced ESCC

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

266

Start Date

2024-03-08

Completion Date

2026-12-31

Last Updated

2024-04-09

Healthy Volunteers

No

Interventions

DRUG

anlotinib

Drug: Camrelizumab 200mg on Day 1 of each 3-week cycle for 2 cycles during the neoadjuvant period Drug: Carboplatin Area under the curve of 5 on Day 1 of each 3-week cycle for 2 cycles Drug: Cisplatin 75 mg/m2 on Day 1 of each 3-week cycle, for 2 cycles Drug: Paclitaxel 135-175 mg/m2 on Day 1 of each 3-week cycle for 2 cycles Drug: Nab-Paclitaxel 220-260 mg/m2 on Day 1 of each 3-week cycle for 2 cycles Drug: anlotinib 8 mg/day orally (from days 1 to 14 in a 21-day cycle) for 2 cycles

RADIATION

Thoracic radiotherapy

Drug: Camrelizumab 200mg on Day 1 of each 3-week cycle for 2 cycles during the neoadjuvant period Drug: Carboplatin Area under the curve of 5 on Day 1 of each 3-week cycle for 2 cycles Drug: Cisplatin 75 mg/m2 on Day 1 of each 3-week cycle, for 2 cycles Drug: Paclitaxel 135-175 mg/m2 on Day 1 of each 3-week cycle for 2 cycles Drug: Nab-Paclitaxel 220-260 mg/m2 on Day 1 of each 3-week cycle for 2 cycles Thoracic radiotherapy RT once daily (from cycle 1 \[C1D1\], 41.4Gy/23Fx, 1.8Gy daily, for 4.6 weeks, 5 days/week)

Locations (1)

Army Medical Center of PLA

Chongqing, None Selected, China