Actively Recruiting
Adebrelimab Combined With Chemotherapy for the Esophageal Squamous Cell Carcinoma
Led by The Second Hospital of Shandong University · Updated on 2026-02-24
25
Participants Needed
1
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adebrelimab Combined With Chemotherapy for the Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed diagnosis of Esophageal Squamous Cell Carcinoma (ESCC)
- Stage II or III disease based on AJCC/UICC 8th edition TNM system, with cT1-3N1-2M0 or cT3-4aN0M0
- Ability to tolerate chemotherapy and surgery after evaluation and multidisciplinary team discussion
- Agreement to follow the clinical trial protocol
You will not qualify if you...
- History of other uncured malignancies within the past 5 years
- Ongoing or past autoimmune diseases
- Prior anti-tumor therapy
- Cardio-pulmonary function not sufficient to tolerate surgery or chemotherapy
- Declining to follow the clinical trial protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Second Qilu Hospital of Shandong University
Jinan, China
Actively Recruiting
Research Team
Y
Yunpeng Zhao, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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