Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07317609

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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