NCRT Combined With Sequential Perioperative PD-1 Inhibitor for LAESCC

N/AActive Not RecruitingNCT06762158

RenJi Hospital50 enrolled

Overview

This study aims to examine the efficacy of the combination of neoadjuvant chemoradiotherapy and perioperative PD-1 inhibitor in patients with locally advanced esophageal squamous cell cancer and explore the predictive biomarkers for this regimen.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

Neoadjuvant ChemoradiotherapyRADIATION

Neoadjuvant chemoradiotherapy: 1. Radiation dose: 1.8Gy/Fx, DT41.4Gy/23Fx. 2. Concurrent chemotherapy: Albumin-bound paclitaxel 60mg/m² + Cisplatin 25mg/m² on D1, D8, D15, D22, D29.

neoadjuvant immunotherapyDRUG

Begins on the second day after the completion of concurrent chemoradiotherapy, and no later than one week. Toripalimab 240mg Q3W, for a total of two cycles.

SurgeryPROCEDURE

Preoperative assessment is conducted 3 weeks after the last neoadjuvant immunotherapy, and surgery is performed within 4-6 weeks. All patients undergo minimally invasive radical esophagectomy, either McKeown or Ivor-Lewis, with extended two-field or three-field lymph node dissection.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18-75 years old * Histologically or cytologically confirmed esophageal squamous cell cancer * Stage T3-4aN0M0 or TanyN1-3M0 according to the American Joint Committee on Cancer staging manual eighth edition * Eastern Cooperative Oncology Group performance status of 0 or 1 * he indexes of hematology, biochemistry and organ function meet the following requirements: a. white blood cell count (WBC) ≥ 3.0×109/L；b. neutrophil count (ANC) ≥ 1.5×109/L; c. platelets ≥ 85×109/L; d. hemoglobin ≥ 90g/L; e. total bilirubin ≤ 1.5 ULN; f. ALT ≤ 1.5 ULN; g. creatinine clearance rate \>60 mL/min; * The cardiopulmonary function needs to meet the following criteria: EF ≥ 55%, VC \> 60%, FEV1 \> 1.2L, FEV1%\> 40%, DLco \> 40% * Women of childbearing age must undergo a pregnancy test within 7 days before enrollment for treatment, and only those with a negative result can be enrolled * Voluntarily participating in this study Exclusion Criteria: * Patients with active infection within 2 weeks before the first use of the study drug * A history of interstitial lung disease or non-infectious pneumonia * A history of autoimmune diseases or abnormal immune system * Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction * Patients diagnosed with any other malignant tumor within 5 years before enrollment, except for malignant tumors with low risk of recurrence and risk of death, such as fully treated basal cell or squamous cell skin and carcinoma in situ of the cervix; * Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of Toripalimab, and the chemotherapeutic drugs nab-paclitaxel or cisplatin * A history of immunodeficiency，including a positive HIV test result or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation * Women during pregnancy or lactation * Other situations not suitable for enrollment

Locations (1)

Radiation Oncology Department, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

pathologically complete response(pCR)

absence of viable tumor cells in the resected cancer specimen（ypT0N0）

Time frame: From date of surgery to 4 weeks later

Secondary Outcomes

event free survival

From date of treatment until the date of death from any cause or the date of disease progression, assessed up to 24 months.

Time frame: 24 months

Data from ClinicalTrials.gov

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