Actively Recruiting
Efficacy and Safety of Adebrelimab Combined With Chemoradiotherapy in Patients With Unresectable Locally Advanced or Postoperative Recurrent Esophageal Squamous Cell Carcinoma
Led by Nanfang Hospital, Southern Medical University · Updated on 2026-04-14
30
Participants Needed
1
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study was a single-center, single-arm, open-label phase II clinical trial. Thirty patients with unresectable locally advanced or postoperative recurrent esophageal squamous cell carcinoma were treated with concurrent chemoradiotherapy combined with immunotherapy. The radiotherapy regimen was intensity-modulated radiotherapy with PGTV at 50-50.4 Gy/25-28 fractions, 1.8-2 Gy per fraction, five times a week. The chemotherapy regimen was paclitaxel 50 mg/m2 and cisplatin 25 mg/m2 intravenous infusion on day 1, once a week for five times. The immunotherapy was with adebutilimab at 20 mg/kg on day 1, every three weeks for three times. One week before radiotherapy, gastroscopy, chest CT or PET-CT images were taken as the baseline standard. Based on the results of gastroscopy, chest CT or PET-CT before and after treatment, the number of patients with complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) in the two groups was observed. The objective response rate (ORR) was calculated as CR + PR, and the disease control rate (DCR) was calculated as CR + PR + SD. The progression-free survival (PFS), overall survival (OS), 1-year and 2-year survival rates and adverse reactions were also statistically analyzed.
CONDITIONS
Official Title
Efficacy and Safety of Adebrelimab Combined With Chemoradiotherapy in Patients With Unresectable Locally Advanced or Postoperative Recurrent Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, any gender
- Confirmed diagnosis of esophageal squamous cell carcinoma that is unresectable locally advanced or postoperative recurrent
- At least one measurable tumor lesion with no prior radiotherapy to that lesion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of at least 12 weeks
- Laboratory values: neutrophils ≥1.5 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin ≥9 g/L, albumin ≥2.8 g/dL, bilirubin ≤1.5 times upper limit of normal, ALT and AST ≤2.5 times upper limit of normal
- Willingness to provide tissue samples for biomarker analysis, preferably newly obtained
- Voluntary participation with signed informed consent and good compliance for follow-up
You will not qualify if you...
- Diagnosis of other malignant tumors within the previous 5 years
- Presence of distant organ metastasis (including supraclavicular lymph node metastasis)
- Tumor invading the trachea or large blood vessels or high risk of esophageal/tracheal fistula or bleeding
- History of active autoimmune disease
- Uncontrolled heart disease
- Active infection or fever (excluding tumor-related fever)
- History or evidence of interstitial lung disease or active non-infectious pneumonia
- Immune dysfunction or active hepatitis
- Prior treatment with PD-1 or PD-L1 antibody therapy
- Allergy to any drug used in this trial
- Use of immunosuppressive drugs or corticosteroids over 10 mg/day prednisone within 14 days before enrollment
- Receipt of radiotherapy, chemotherapy, targeted therapy, or immunotherapy within 4 weeks before enrollment
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
W
Wei Wang
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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