Neoadjuvant Immunotherapy Combined With Chemotherapy Sequenced With Endoscopic Resection for Esophageal Cancer (Endosurgery-02)
Status and phase
Conditions
Treatments
Details and patient eligibility
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Cohort A - Potentially resectable ESCC:
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:
- 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;
- Patients who are currently participating in any other clinical study.
Cohort B - Surgery-contraindicated ESCC:
Inclusion Criteria:
- Individuals aged above 18 years;
- Patients diagnosed with esophageal squamous cell carcinoma through histopathological examination of biopsy tissues from the primary tumor;
- Patients with esophageal cancer deemed as surgically contraindicated (including those with cervical esophageal cancer, surgical contraindications, those who refuse surgery, or those considered high-risk for esophagectomy, defined as having at least one of the following characteristics: (1) age over 75 years, (2) Charlson comorbidity index >= 2, (3) presence of moderate lung dysfunction, (4) malnutrition (with a body mass index below 18 kg/m^2)), with a clinical staging of cT1b-3N0M0, a tumor size not exceeding 5 cm, and occupying less than 2/3 of the luminal circumference;
- Patients who have not undergone any antitumor treatment, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, and targeted therapy;
- Female patients of reproductive age should have a negative pregnancy test and be willing to adopt effective contraceptive measures during the study period;
- Patients who have signed the informed consent form.
Exclusion Criteria:
- Patients with allergies to the drugs or related components involved in this study;
- Patients who are currently participating in any other clinical study.
Trial design
Primary purpose
Allocation
Interventional model
Masking
60 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Li-Yun Ma, MD
Data sourced from clinicaltrials.gov
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