Adebrelimab Combined With Neoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma

Официальное название

A Study on the Safety and Efficacy of Adalimumab Combined With Chemoradiotherapy as Neoadjuvant Therapy for Esophageal Squamous Cell Carcinoma

Обзор

This study aims to systematically evaluate the safety and efficacy of adalimumab combined with paclitaxel, carboplatin, and short-course radiotherapy in the neoadjuvant treatment of esophageal squamous cell carcinoma.

Подробное описание

CROSS Study showed that the pathological complete response (pCR) rate of patients with esophageal cancer (23% of whom were esophageal squamous cell carcinoma, ESCC) after neoadjuvant radiotherapy and chemotherapy was 29%. NEOCRTEC5010 Study showed that the pCR rate was 43.2% in locally advanced esophageal squamous cell carcinoma, which means that more than half of patients still cannot achieve ideal therapeutic effects from existing treatment options. In addition, the recurrence rate after surgical resection compromises the long-term survival rate of patients. Therefore, exploring new treatment strategies to improve the treatment efficacy and survival rate of esophageal cancer patients has important clinical significance. Currently, the significance of immunotherapy combined with chemoradiotherapy in terms of pathological complete response (pCR) rates and postoperative survival quality for locally advanced esophageal squamous cell carcinoma remains unclear. Therefore, this study aims to systematically evaluate the safety and efficacy of adebrelimab in combination with paclitaxel, carboplatin, and short-course radiotherapy as neoadjuvant therapy for ESCC. By integrating immunotherapy with existing standard treatment regimens, this study seeks to significantly improve pCR rates, optimize surgical resection outcomes, ultimately prolong disease-free survival (DFS), and enhance overall survival (OS). The implementation of this study is expected to provide innovative approaches and methods for the clinical treatment of ESCC, holding important clinical application value and significance.

Вмешательства

• Препарат • Adebrelimab and nab-paclitaxel, carboplatin in Combination With radiotherapy
  Patients would receive Adebrelimab (IV 1200mg d1) and nab-paclitaxel (IV 220 mg/m²d1) plus carboplatin (AUC = 5, d1) for two 21-day cycles, followed by one week off for radiotherapy (2.5 ⨉12 Gy). After radiotherapy, another cycle of Adebrelimab (IV 1200mg d1) would be given. 4 to 6 weeks after completing the neoadjuvant therapy, patients would undergo esophagectomy.

Первичные конечные точки

• Pathological complete response (pCR) [Срок оценки: From patient enrollment to the end of surgery]

Вторичные конечные точки (7)

• R0 resection rate [Срок оценки: From patient enrollment to the end of surgery]
• Disease free survival (DFS) [Срок оценки: up to 24 months post-surgery]
• Overall survival (OS) [Срок оценки: up to 24 months after surgery]
• Major pathological remission (MPR) [Срок оценки: From patient enrollment to the end of surgery]
• Progression free survival (PFS) [Срок оценки: Up to 24 months post-surgery]
• Event free survival (EFS) [Срок оценки: From patient enrollment to the end of surgery]
• Adverse Events [Срок оценки: from the first drug administration to within 30 days for the last Adebrelimab dose]

Критерии участия

Критерии включения

• \- 1. Provided informed consent and sign the informed consent form;
• 2\. Male or female, Aged 18-75 years (counted on the date of signing informed consent);
• 3\. Pathological confirmed ESCC;
• 4\. Patients assessed by thoracic oncologists as resectable without distant metastasis
• 5\. Patients evaluate with clinical staging of T1-4aN1-3M0 or T3-4aN0M0(AJCC 9.0) based on imaging and pathological examination results;
• 6\. Have at least one assessable lesion according to the RECIST V1.1
• 7\. ECOG-PS score: 0-1;
• 8\. Patients with normal function of organs such as heart, brain, lungs, and kidneys who can tolerate surgery;
• 9\. With a life expectancy of ≥ 6 weeks;
• 10\. Adequate major organ function without severe hematologic, cardiac, pulmonary, hepatic, renal, or bone marrow dysfunction, and no immunodeficiency disease;

Критерии исключения

• 1\. Patients who have received or are currently receiving chemotherapy, radiotherapy, immunotherapy, or targeted therapy
• 2\. Patients with distant metastasis or inability to undergo resection after evaluation by thoracic surgeons
• 3\. Simultaneously developing tumors in other parts of the body
• 4\. Severe impairment of heart, liver, and kidney function (heart function grade 3-4, ALT and/or AST exceeding the upper limit of normal by more than 1.5 times, Cr (serum creatinine) exceeding the upper limit of normal by more than 1.5 times)
• 5\. Patients with a history of autoimmune diseases who were receiving immunosuppressive therapy prior to enrollment, with immunosuppressive doses>10 mg/day or oral prednisone for more than 2 weeks
• 6\. Severe allergy to immune preparations
• 7\. Abnormal coagulation function: (PT>16s, APTT>53s, TT>21s, Fib<1.5 g/L), bleeding tendency or during thrombolytic or anticoagulant therapy
• 8\. Pregnancy or lactation period
• 9\. Other situations as judged by investigators not suitable for inclusion.;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Гуанчжоу

Идентификаторы

NCT: NCT07595770 · SYSKY-2025-799-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗