Adebrelimab Combined With Chemotherapy for the Esophageal Squamous Cell Carcinoma
A Single-arm, Single-center, Exploratory Clinical Study of Adebrelimab Combined With Neoadjuvant Chemotherapy for the Treatment of Esophageal Squamous Cell Carcinoma
The Second Hospital of Shandong University
25 participants
Dec 9, 2024
INTERVENTIONAL
Conditions
Summary
This study is a prospective, single-arm, phase II exploratory clinical trial. The primary endpoint of this study is to evaluate the pathological complete response (pCR) rate after surgery and to assess the safety of neoadjuvant therapy with adebrelimab combined with platinum-based chemotherapy in patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC) at the Second Qilu Hospital of Shandong University. The primary endpoint of this clinical trial is the pathological complete response (pCR) rate, defined as the absence of residual viable tumor cells in the resected specimen, including lymph nodes (ypT0N0M0). Secondary endpoints include the major pathological response (MPR) rate, objective response rate (ORR), treatment-related adverse events (TRAEs) and immune-related adverse events (irAEs), as well as quality of life (QOL) assessments during neoadjuvant immunochemotherapy (nICT). MPR is defined as less than 10% residual viable tumor cells in the primary tumor bed following neoadjuvant therapy and resection. ORR represents the percentage of patients achieving complete response (CR) or partial response (PR). Other secondary measures include the tumor downstaging rate, surgery rate, R0 resection rate (defined as no residual tumor at the resection margins), and perioperative complication rate. Furthermore, overall survival (OS) and relapse-free survival (RFS) are considered exploratory endpoints in this study. By evaluating these diverse endpoints, the investigators aim to comprehensively assess the efficacy, safety, and overall impact of the nICT approach in patients with locally advanced resectable ESCC. Additionally, it is planned to construct 20 pairs of esophageal squamous cell carcinoma and adjacent normal esophageal squamous epithelial organoids, laying the groundwork for future in-depth exploration of the mechanisms underlying esophageal carcinogenesis and progression, as well as functional studies of specific genes.
Eligibility
Inclusion Criteria3
- Patients must have a histopathologically confirmed diagnosis of Esophageal Squamous Cell Carcinoma （ESCC）.
- Eligible patients are those with stage II/III disease according to the AJCC/UICC 8th edition Tumor-Node-Metastasis (TNM) staging system, presenting with cT1-3N1-2M0 or cT3-4aN0M0 disease.
- Patients could tolerate chemotherapy and surgery after evaluation and MDT discussion, accepting the clinical trial protocol.
Exclusion Criteria2
- Patients with a history of other uncured malignancies within the past 5 years, individuals with ongoing or a history of autoimmune diseases, and those who have received any prior anti-tumor therapy.
- Patients' cardio- pulmonary function could not tolerate surgery or chemotherapy, or don't accept the clinical trial protocol.
Interventions
The treatment regimen consisted of adebrelimab combined with chemotherapy, administered every 3 weeks per cycle according to the study protocol. The specific treatment regimen was as follows: Adebrelimab: 20 mg/kg, intravenous infusion on day 1 of each 3-week cycle; Cisplatin: 75 mg/m², intravenous injection on day 2 of each cycle, or Carboplatin: area under the curve (AUC) 5, intravenous injection on day 2 of each cycle; Liposomal paclitaxel: 175 mg/m², intravenous injection on day 2 of each cycle, or Nab-paclitaxel: 260 mg/m², intravenous infusion over 30 minutes on day 2 of each cycle.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07430579