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NCT Number: NCT07317609

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

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.

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Key information

Conditions

Esophageal Squamous Cell Carcinoma (ESCC) Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Carcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Li-Yun Ma, MD

CONTACT

[email protected]

+86 13162909612

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tislelizumab

Drug

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.

carboplatin

Drug

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

Nab-paclitaxel

Drug

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

Endoscopic resection

Procedure

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.

Esophagectomy

Procedure

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.

Concurrent Chemoradiation

Radiation

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.

Primary outcomes

  1. Organ preservation rate

    Time frame: Up to 12 months after completion of neoadjuvant therapy

    Proportion of enrolled participants who achieve esophageal organ preservation after neoadjuvant therapy, defined as: (1) clinical complete response at reassessment ~3-4 weeks after ≥2 cycles; (2) endoscopic tumor resection (e.g., ESD) performed 3-6 weeks after therapy with curative intent and negative margins (R0) when resection is undertaken; and (3) no planned or salvage esophagectomy through 12 months. Participants who require esophagectomy, have persistent/progressive disease precluding endoscopic therapy, or die before assessment are counted as non-preserved.

  2. Overall safety: incidence of Grade ≥3 adverse events related to drug, endoscopic procedures, surgery, or radiation

    Time frame: Adverse event was assessed peri-procedural of drug-using, endoscopic procedures, surgery, or radiation up to 30 days

    Proportion of participants with at least one Grade ≥3 adverse event from any study-specified modality:

    • Drug-related treatment-related adverse events (TRAEs) graded by CTCAE v5.0 .
    • Endoscopic complications when resection is performed (clinically significant bleeding requiring intervention, perforation, or stricture requiring dilation/stenting), adjudicated per institutional/ASGE criteria;
    • Surgical morbidity after esophagectomy (Clavien-Dindo grade ≥III within 90 days of surgery);
    • Radiation toxicities among those receiving concurrent chemoradiation (CTCAE v5.0 grade ≥3).

    Serious adverse events (SAEs) (death, life-threatening event, inpatient hospitalization/prolongation, disability, or other medically important event) and 30-/90-day all-cause mortality are captured; if multiple events occur, the worst grade counts for this composite endpoint

  3. Two-year overall survival rate

    Time frame: From Day 1 of the first neoadjuvant dose to 24 months

    Proportion of participants alive 24 months after index date regardless of cause of death (all-cause mortality). The index date is Day 1 of the first neoadjuvant cycle. Survival status is ascertained from clinic visits, hospital records, and scheduled follow-up contacts. The OS rate at 24 months will be estimated using the Kaplan-Meier method with 95% confidence interval. Participants alive at last contact before 24 months are censored at that date; deaths at any time up to 24 months count as events, including those occurring after endoscopic resection, esophagectomy, or chemoradiation.

  4. Biomarkers

    Time frame: Baseline and the day 1 of endoscopy or surgery

    Tumor tissue samples and blood samples will be collected for tumor biomarker analysis, including but not limited to analyses of metabolic markers, circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), T-cell receptor sequencing (TCR-seq), and RNA sequencing (RNA-seq).

Study contacts

Contact information is provided by the study sponsor or research team.

Li-Yun Ma, MD

CONTACT

[email protected]

+86 13162909612

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Acronym: Endosurgery-02

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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