NCRT Combined With Sequential Perioperative PD-1 Inhibitor for LAESCC

NCT ID: NCT06762158

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-30
• Study Completion Date: 2029-12-01

Brief Summary

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.

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Perioperative toripalimab

neoadjuvant chemoradiotherapy and perioperative toripalimab

Group Type: EXPERIMENTAL

Neoadjuvant Chemoradiotherapy

Intervention Type: RADIATION

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 immunotherapy

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: RADIATION

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.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

LY2024-217-A

Identifier Type: -

Identifier Source: org_study_id