Actively Recruiting
A Single-arm, Open, Single-center Exploratory Study of Adebrelimab (SHR-1316) in Combination With Chemotherapy for the Perioperative Treatment of Locally Advanced Resectable Esophageal Squamous Carcinoma
Led by Peking University Cancer Hospital & Institute · Updated on 2025-10-02
30
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, observational clinical study. In this study, 30 patients with resectable locally advanced esophageal squamous carcinoma will be prospectively enrolled and treated with adebrelimab (SHR-1316) combined with nab-paclitaxel and cisplatin preoperatively and adebrelimab (SHR-1316) single-agent adjuvant therapy postoperatively, to observe the efficacy and safety of this treatment modality, and to provide clinical evidence for the use of PD-L1 monoclonal antibody in perioperative treatment of esophageal cancer.
CONDITIONS
Official Title
A Single-arm, Open, Single-center Exploratory Study of Adebrelimab (SHR-1316) in Combination With Chemotherapy for the Perioperative Treatment of Locally Advanced Resectable Esophageal Squamous Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years old, any gender
- Locally advanced squamous cell carcinoma of the esophagus that can be surgically removed, confirmed by biopsy or cell analysis
- Presence of measurable or non-measurable tumors according to RECIST v1.1 criteria
- No previous cancer treatment for esophageal cancer, including chemotherapy, radiotherapy, hormone therapy, or immunotherapy
- ECOG performance status of 0 or 1
- No surgery contraindications based on organ function tests
- Adequate bone marrow, liver, and kidney function confirmed by lab tests before treatment without recent blood transfusions or stimulating factors
- Willing and able to sign informed consent form
You will not qualify if you...
- Other malignant tumors within 5 years before enrollment, except certain cured limited tumors like cervical carcinoma in situ, skin basal cell carcinoma, and prostate carcinoma in situ
- Serious heart or cerebrovascular diseases including heart failure, unstable angina, recent heart attack, poorly controlled arrhythmia, or stroke of NYHA class II or higher within 12 months
- Uncontrolled high blood pressure or history of hypertensive crisis
- Past interstitial lung disease or pneumonia requiring steroid treatment
- Blood-borne infections such as hepatitis B or C, syphilis, or HIV
- Severe allergy to chemotherapeutic agents (paclitaxel or carboplatin) or monoclonal antibodies
- Active autoimmune disease needing systemic therapy in the past 2 years (some replacement therapies allowed)
- Pregnant women
- Any other condition making the investigator judge the patient unsuitable for the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital
Beijing, China, 100142
Actively Recruiting
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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