NCRT Combined With Sequential Perioperative PD-1 Inhibitor for LAESCC

December 31, 2024 updated by: RenJi Hospital

Neoadjuvant Chemoradiotherapy Combined With Sequential Perioperative PD-1 Inhibitor for Locally Advanced Esophageal Squamous Cell Carcinoma

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Radiation Oncology Department, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perioperative toripalimab
neoadjuvant chemoradiotherapy and perioperative toripalimab
Radiation: Neoadjuvant Chemoradiotherapy

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.
Drug: neoadjuvant immunotherapy
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.
Procedure: Surgery
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.
Drug: adjuvant immunotherapy
Whether to undergo postoperative adjuvant immunotherapy is determined based on the pathological response. Patients with pCR are only observed without receiving adjuvant treatment, while those not reaching pCR receive one year of adjuvant Toripalimab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pathologically complete response(pCR)
Time Frame: From date of surgery to 4 weeks later
absence of viable tumor cells in the resected cancer specimen（ypT0N0）
From date of surgery to 4 weeks later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
event free survival
Time Frame: 24 months
From date of treatment until the date of death from any cause or the date of disease progression, assessed up to 24 months.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

December 22, 2024

First Submitted That Met QC Criteria

December 31, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 31, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY2024-217-A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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