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OpenTrials
Active, Not Recruiting

NCT Number: NCT06762158

NCRT Combined With Sequential Perioperative PD-1 Inhibitor for LAESCC

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Shanghai, Shanghai Municipality, 200127, China

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

neoadjuvant chemoradiotherapy

Radiation

Neoadjuvant chemoradiotherapy:

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

neoadjuvant immunotherapy

Drug

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.

Surgery

Procedure

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.

adjuvant immunotherapy

Drug

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

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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