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NCT07317609

PHASE1

Neoadjuvant Immunotherapy Combined With Chemotherapy Sequenced With Endoscopic Resection for Esophageal Cancer (Endosurgery-02)

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

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.

Official title: Safety and Feasibility of Neoadjuvant Immunotherapy Combined With Chemotherapy Sequenced With Endoscopic Resection for Esophageal Cancer (Endosurgery-02)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-07-15

Completion Date

2027-09-30

Last Updated

2026-01-05

Healthy Volunteers

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

DRUG

Tislelizumab

Fixed-dose anti-PD-1 monoclonal antibody 200 mg IV on Day 1 of each 3-week cycle (Q3W) as neoadjuvant therapy, administered before any local resection. Given for ≥2 cycles unless contraindicated. Used in combination with carboplatin and nab-paclitaxel in a single-arm regimen; no placebo or comparator.

DRUG

Carboplatin

Intervention Description: AUC 3-5 IV on Day 1, Q3W, for ≥2 cycles in combination with tislelizumab and nab-paclitaxel as neoadjuvant therapy.

DRUG

Nab-paclitaxel

≤260 mg/m² IV on Day 1, Q3W (\~30-min infusion) for ≥2 cycles, combined with tislelizumab and carboplatin in the neoadjuvant regimen.

PROCEDURE

Endoscopic resection

Endoscopic resection (e.g., ESD/EFTR) performed 3-6 weeks after completing ≥2 neoadjuvant cycles only if clinical complete response (cCR) is achieved without clear nodal metastasis, based on endoscopy/EUS and imaging. Technique follows institutional standards with curative intent and margin assessment.

PROCEDURE

Esophagectomy

Standard surgical esophagectomy (McKeown/Ivor-Lewis procedures) for participants not meeting cCR criteria or deemed unsuitable for endoscopic resection after reassessment. Conducted per institutional standard of care, with lymphadenectomy as appropriate.

RADIATION

Concurrent chemoradiation

Concurrent chemoradiation per institutional standard for participants not eligible for endoscopic resection and managed non-surgically after reassessment. External-beam radiation delivered with concurrent platinum-taxane chemotherapy as clinically indicated; specific dose/fractionation per treating radiation oncologist.

Cohort A - Potentially resectable ESCC: Inclusion Criteria： 1. Age range: 18-80 years old; 2. Patients diagnosed with esophageal squamous cell carcinoma (ESCC) through histopathological examination of biopsy tissues from the primary tumor; 3. 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; 4. Patients with a preoperative Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 5. Patients with a preoperative American Society of Anesthesiologists (ASA) physical status classification of I-III; 6. Female patients of reproductive age should have a negative pregnancy test and be willing to use effective contraceptive methods during the study period; 7. Patients who have signed the informed consent form. Exclusion Criteria: 1. Patients with potential tracheoesophageal fistula or aortoesophageal fistula; 2. Patients with severe malnutrition or requiring tube feeding; 3. 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); 4. Patients with active autoimmune diseases or a history of autoimmune diseases or symptoms that require systemic corticosteroid treatment or anti-autoimmune drug therapy; 5. 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; 6. Patients with active infections requiring systemic treatment within 7 days before the first neoadjuvant therapy in this study; 7. Patients with a history of allogeneic organ or stem cell transplantation; 8. Patients with allergies to drugs or related components involved in this study; 9. Patients who are currently participating in any other clinical study. Cohort B - Surgery-contraindicated ESCC: Inclusion Criteria: 1. Individuals aged above 18 years; 2. Patients diagnosed with esophageal squamous cell carcinoma through histopathological examination of biopsy tissues from the primary tumor; 3. 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; 4. Patients who have not undergone any antitumor treatment, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, and targeted therapy; 5. Female patients of reproductive age should have a negative pregnancy test and be willing to adopt effective contraceptive measures during the study period; 6. Patients who have signed the informed consent form. Exclusion Criteria: 1. Patients with allergies to the drugs or related components involved in this study; 2. Patients who are currently participating in any other clinical study.

Locations (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Clinical Research Directory

Neoadjuvant Immunotherapy Combined With Chemotherapy Sequenced With Endoscopic Resection for Esophageal Cancer (Endosurgery-02)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)