Actively Recruiting
Neoadjuvant Immunotherapy Combined With Chemotherapy Sequenced With Endoscopic Resection for Esophageal Cancer (Endosurgery-02)
Led by Shanghai Zhongshan Hospital · Updated on 2026-01-05
60
Participants Needed
1
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This single-center, prospective, single-arm study will evaluate whether giving neoadjuvant chemoimmunotherapy can safely shrink esophageal cancer and allow organ-preserving endoscopic removal in selected patients. Adults with esophageal cancer will receive at least two 3-week cycles of a PD-1 inhibitor (tislelizumab 200 mg on Day 1) plus carboplatin (AUC 3-5, Day 1) and nab-paclitaxel (≤260 mg/m², Day 1). During treatment, routine safety tests are performed. About 3-4 weeks after completing at least two cycles, participants undergo clinical reassessment with examinations and imaging (such as endoscopy, endoscopic ultrasound, PET/CT or CT of the neck, chest, and upper abdomen) to evaluate tumor shrinkage and possible spread. Tumor response is assessed using RECIST 1.1. If a clinical complete response is achieved without obvious nodal disease, endoscopic resection may be performed to preserve the esophagus; otherwise, patients may proceed to surgery or concurrent chemoradiation per clinical judgment. The study focuses on feasibility and safety of this organ-preserving approach and describes tumor responses after therapy. Potential benefits include tumor shrinkage and avoiding major surgery in selected cases; risks include side effects of standard chemotherapy/immunotherapy and procedure-related discomforts from biopsies or endoscopic treatments.
CONDITIONS
Official Title
Neoadjuvant Immunotherapy Combined With Chemotherapy Sequenced With Endoscopic Resection for Esophageal Cancer (Endosurgery-02)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old for potentially resectable esophageal squamous cell carcinoma
- Diagnosis of esophageal squamous cell carcinoma by biopsy
- Potentially resectable esophageal cancer confirmed by imaging and endoscopy (T1b-3, N0, M0, tumor size ≤5 cm and less than 2/3 luminal circumference)
- No prior antitumor treatments including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy
- ECOG performance status score of 0 or 1
- ASA physical status classification I-III
- Female patients of reproductive age must have a negative pregnancy test and agree to use effective contraception during the study
- Signed informed consent form
- For surgery-contraindicated esophageal squamous cell carcinoma: Age above 18 years
- Surgically contraindicated esophageal cancer or refusal/high surgical risk (age >75, Charlson comorbidity index ≥2, moderate lung dysfunction, malnutrition with BMI <18 kg/m²)
- Clinical staging cT1b-3N0M0, tumor size ≤5 cm and less than 2/3 luminal circumference
- No prior antitumor treatments
- Female patients of reproductive age must have a negative pregnancy test and agree to use effective contraception during the study
- Signed informed consent form
You will not qualify if you...
- Presence of potential tracheoesophageal or aortoesophageal fistula
- Severe malnutrition requiring tube feeding
- Other malignancies not cured within past 2 years (except cured basal cell carcinoma of skin or carcinoma in situ of cervix)
- Active autoimmune diseases or history requiring systemic corticosteroids or anti-autoimmune therapy
- Immunocompromised or receiving systemic steroids >10 mg/day prednisone or equivalent within 7 days before first treatment
- Active infections requiring systemic treatment within 7 days before first treatment
- History of allogeneic organ or stem cell transplantation
- Allergies to study drugs or related components
- Current participation in any other clinical study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
L
Li-Yun Ma, MD
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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