Actively Recruiting
Safety and Efficacy of Adalimumab Combined With Chemoradiotherapy as Pre-Surgery Treatment for Esophageal Squamous Cell Carcinoma
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2026-05-19
37
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor
J
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining adebrelimab with paclitaxel, carboplatin, and short-course radiotherapy before surgery to treat esophageal squamous cell carcinoma (ESCC). This study aims to improve the rate of complete tumor removal and survival outcomes for patients with this type of esophageal cancer, as current treatments still leave many patients without ideal results and face high recurrence rates after surgery. The study is a Phase 2 clinical trial focused on integrating immunotherapy with standard treatments to enhance patient outcomes. Participants receive an initial treatment of adebrelimab through intravenous infusion along with nab-paclitaxel and carboplatin in two 21-day cycles. This is followed by a one-week break for radiotherapy over five days. After radiotherapy, patients receive another adebrelimab infusion. Surgery to remove the esophagus (esophagectomy) is scheduled 4 to 6 weeks after completing the neoadjuvant therapy to assess the tumor's response. During the study, patients will be monitored for pathological complete response (pCR) from enrollment to surgery, as well as other measures such as disease-free survival, overall survival, and adverse events up to 24 months after surgery. Researchers will evaluate surgical outcomes, tumor remission, and treatment safety through clinical exams, imaging, and laboratory tests. Participants are observed closely from the start of treatment through surgery and follow-up to understand how well this combined approach works and how safe it is for patients.
CONDITIONS
Brief Title
Adebrelimab Combined With Neoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent and signed the informed consent form
- Male or female aged 18-75 years at the time of consent
- Pathologically confirmed esophageal squamous cell carcinoma
- Assessed by thoracic oncologists as resectable without distant metastasis
- Clinical staging of T1-4aN1-3M0 or T3-4aN0M0 based on imaging and pathology
- At least one assessable lesion according to RECIST V1.1
- ECOG performance status score of 0-1
- Normal heart, brain, lung, and kidney function to tolerate surgery
- Life expectancy of at least 6 weeks
- Adequate organ function without severe hematologic, cardiac, pulmonary, hepatic, renal, or bone marrow dysfunction, and no immunodeficiency disease
You will not qualify if you...
- Prior or current chemotherapy, radiotherapy, immunotherapy, or targeted therapy
- Presence of distant metastasis or inability to undergo resection after surgical evaluation
- Concurrent tumors in other parts of the body
- Severe impairment of heart, liver, or kidney function (heart grade 3-4, ALT/AST >1.5 times normal, creatinine >1.5 times normal)
- History of autoimmune diseases requiring immunosuppressive therapy with doses over 10 mg/day or oral prednisone use longer than 2 weeks
- Severe allergy to immune therapies
- Abnormal blood clotting or bleeding disorders, or on blood thinners
- Pregnancy or breastfeeding
- Other conditions judged by investigators as unsuitable for inclusion
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 weeks
Participants receive two 21-day cycles of Adebrelimab, nab-paclitaxel, and carboplatin as part of neoadjuvant therapy.
2 treatment visits (in-person, every 21 days)
Duration - Approximately 4 weeks
Participants undergo one week of radiotherapy followed by one cycle of Adebrelimab before surgery.
1 week of daily radiotherapy visits and 1 treatment visit (in-person)
Duration - Single surgical event
Participants undergo esophagectomy 4 to 6 weeks after completing neoadjuvant therapy.
1 surgery visit (in-person)
Duration - Up to 24 months
Participants are monitored for disease-free survival, overall survival, and adverse events for up to 24 months after surgery.
Regular follow-up visits for up to 24 months post-surgery
Trial Site Locations
Total: 1 location
1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
B
Baisheng Chen, M.D, PhD
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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