NCT07430579 Adebrelimab Combined With Chemotherapy for the Esophageal Squamous Cell Carcinoma
| NCT ID | NCT07430579 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Second Hospital of Shandong University |
| Condition | Pathological Complete Remission |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-12-09 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2024-12-09 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Patients must have a histopathologically confirmed diagnosis of Esophageal Squamous Cell Carcinoma （ESCC）. 2. 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. 3. Patients could tolerate chemotherapy and surgery after evaluation and MDT discussion, accepting the clinical trial protocol. Exclusion Criteria: 1. 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. 2. Patients' cardio- pulmonary function could not tolerate surgery or chemotherapy, or don't accept the clinical trial protocol.
Contact & Investigator
Yunpeng Zhao, doctor
STUDY DIRECTOR
The Second Qilu Hospital of Shandong University
Frequently Asked Questions
Who can join the NCT07430579 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Pathological Complete Remission. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07430579 currently recruiting?
Yes, NCT07430579 is actively recruiting participants. Contact the research team at zhaoyunpengsddx@sdu.edu.cn for enrollment information.
Where is the NCT07430579 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT07430579 clinical trial?
NCT07430579 is sponsored by The Second Hospital of Shandong University. The principal investigator is Yunpeng Zhao, doctor at The Second Qilu Hospital of Shandong University. The trial plans to enroll 25 participants.