Adebrelimab plus platinum chemotherapy before surgery for operable 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
This trial will try giving adebrelimab with platinum-based chemotherapy before surgery in people with locally advanced, resectable esophageal squamous cell carcinoma to see if it increases complete tumor disappearance and is safe.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The Second Hospital of Shandong University Academic / other |
| Drugs / interventions | chemotherapy, adebrelimab, immunotherapy |
| Locations | 1 site (Jinan) |
| Trial ID | NCT07430579 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm phase II trial testing neoadjuvant adebrelimab combined with platinum-based chemotherapy in patients with locally advanced, resectable esophageal squamous cell carcinoma. Participants receive the immunotherapy-plus-chemotherapy regimen prior to planned esophagectomy, with surgical specimens evaluated for pathological response. The primary endpoint is the pathological complete response (pCR) rate (ypT0N0M0); secondary endpoints include major pathological response (MPR), objective response rate (ORR), treatment- and immune-related adverse events, and quality of life during neoadjuvant treatment. Safety and tolerability during the preoperative period are closely monitored and reported.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed stage II–III esophageal squamous cell carcinoma (cT1-3N1-2M0 or cT3-4aN0M0) who have not received prior anti-tumor therapy and are judged able to tolerate chemotherapy and surgery.
Not a fit: Patients with prior anti-cancer treatment, untreated other malignancies within five years, active or history of autoimmune disease, or inadequate cardiac or pulmonary function may not benefit or be eligible for this protocol.
Why it matters
Potential benefit: If successful, this approach could raise the rate of complete tumor eradication at surgery and potentially improve long-term outcomes while maintaining acceptable safety.
How similar studies have performed: Neoadjuvant immunotherapy combined with chemotherapy has shown promising pCR and response signals in early studies of esophageal cancer and other solid tumors, but results are not yet definitive and require further confirmation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jinan
- The Second Qilu Hospital of Shandong University — Jinan, China (Recruiting)
Study contacts
- Study coordinator: Yunpeng Zhao, doctor
- Email: zhaoyunpengsddx@sdu.edu.cn
- Phone: 18766188692
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.