RecruitingPhase 2Phase 3NCT06354530

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

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

Sponsor

Army Medical Center of PLA

Enrollment

266 participants

Start Date

Mar 8, 2024

Study Type

INTERVENTIONAL

Conditions

Neoadjuvant Therapy Esophageal Squamous Cell Carcinoma

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of treatments before surgery for locally advanced esophageal squamous cell carcinoma. Patients will receive a targeted therapy (anlotinib capsules) combined with another anti-cancer regimen to try to shrink the tumor enough to make surgery more effective. **You may be eligible if...** - You have a confirmed diagnosis of esophageal squamous cell carcinoma that may be surgically removed - Your cancer has not yet been treated with any systemic therapy - You are in good physical condition (ECOG score 0 or 1) and your surgeon believes you can tolerate surgery - You can swallow anlotinib capsules by mouth - Your blood counts and organ function meet the required thresholds **You may NOT be eligible if...** - Your BMI is below 18.5 or you have lost more than 10% of your body weight in 2 months - Your cancer has invaded the airway, major blood vessels, or caused a fistula or perforation - You cannot swallow the oral medication - You have had significant weight loss or poor nutritional status Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGanlotinib

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

RADIATIONThoracic 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)