NCRT Combined With Sequential Perioperative PD-1 Inhibitor for LAESCC

NCT06762158 | Active Not Recruiting

• 1 other identifier: LY2024-217-A
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Keywords

esophageal squamous cell cancer; neoadjuvant chemoradiotherapy; perioperative immunotherapy; PD-1 inhibitor

Outcome Measures

Primary Outcomes (1)

• pathologically complete response(pCR)

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

  From date of surgery to 4 weeks later

Secondary Outcomes (1)

• event free survival

  24 months

Study Arms (1)

Perioperative toripalimab

EXPERIMENTAL

neoadjuvant chemoradiotherapy and perioperative toripalimab

Radiation: Neoadjuvant Chemoradiotherapy; Drug: neoadjuvant immunotherapy; Procedure: Surgery; Drug: adjuvant immunotherapy

Interventions

Neoadjuvant Chemoradiotherapy 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.

Perioperative toripalimab

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.

Perioperative toripalimab

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.

Perioperative toripalimab

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.

Perioperative toripalimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Neoadjuvant Therapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: January 7, 2025
• Study Start: October 30, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 7, 2025

Record last verified: 2024-12

Locations

CN (1)