Neoadjuvant Immunotherapy Combined With Chemotherapy Sequenced With Endoscopic Resection for Esop… (NCT07317609) | Clinical Trial Compass
RecruitingPhase 1
Neoadjuvant Immunotherapy Combined With Chemotherapy Sequenced With Endoscopic Resection for Esophageal Cancer (Endosurgery-02)
China60 participantsStarted 2025-07-15
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age range: 18-80 years old;
✓. Patients diagnosed with esophageal squamous cell carcinoma (ESCC) through histopathological examination of biopsy tissues from the primary tumor;
✓. Patients with potentially resectable esophageal cancer confirmed by imaging and endoscopic examinations (T1b-3, N0, M0, with a tumor size not exceeding 5 cm and occupying less than 2/3 of the luminal circumference); Patients who have not received any antitumor treatment, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, and targeted therapy;
✓. Patients with a preoperative Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
✓. Patients with a preoperative American Society of Anesthesiologists (ASA) physical status classification of I-III;
✓. Female patients of reproductive age should have a negative pregnancy test and be willing to use effective contraceptive methods during the study period;
✓. Patients who have signed the informed consent form.
Exclusion criteria
What they're measuring
1
Organ preservation rate
Timeframe: Up to 12 months after completion of neoadjuvant therapy
2
Overall safety: incidence of Grade ≥3 adverse events related to drug, endoscopic procedures, surgery, or radiation
Timeframe: Adverse event was assessed peri-procedural of drug-using, endoscopic procedures, surgery, or radiation up to 30 days
3
Two-year overall survival rate
Timeframe: From Day 1 of the first neoadjuvant dose to 24 months
4
Biomarkers
Timeframe: Baseline and the day 1 of endoscopy or surgery
. Patients with potential tracheoesophageal fistula or aortoesophageal fistula;
✕. Patients with severe malnutrition or requiring tube feeding;
✕. Patients with other malignancies that have not been cured within the past 2 years (except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the cervix);
✕. Patients with active autoimmune diseases or a history of autoimmune diseases or symptoms that require systemic corticosteroid treatment or anti-autoimmune drug therapy;
✕. Immunocompromised patients, or patients who are still receiving systemic steroids (prednisone \> 10 mg/day or equivalent) or other forms of immunosuppressive therapy within 7 days before the first dose of neoadjuvant therapy in this study;
✕. Patients with active infections requiring systemic treatment within 7 days before the first neoadjuvant therapy in this study;
✕. Patients with a history of allogeneic organ or stem cell transplantation;
✕. Patients with allergies to drugs or related components involved in this study;