NCRT Combined With Sequential Perioperative PD-1 Inhibitor for LAESCC

Not Applicable

Active, not recruiting

• Conditions: Esophageal Squamous Cell Carcinoma (ESCC)
• Interventions: Radiation: Neoadjuvant Chemoradiotherapy; Drug: neoadjuvant immunotherapy; Procedure: Surgery; Drug: adjuvant immunotherapy

• Registration Number: NCT06762158
• Lead Sponsor: RenJi Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-30
• Status Verified: 2024-12
• Study First Submitted: 2024-12-22
• Study First Submitted QC: 2024-12-31
• Last Update Submitted: 2024-12-31
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07
• Primary Completion: 2027-12-01
• Study Completion: 2029-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Perioperative toripalimab	Neoadjuvant Chemoradiotherapy	neoadjuvant chemoradiotherapy and perioperative toripalimab
Perioperative toripalimab	neoadjuvant immunotherapy	neoadjuvant chemoradiotherapy and perioperative toripalimab
Perioperative toripalimab	Surgery	neoadjuvant chemoradiotherapy and perioperative toripalimab
Perioperative toripalimab	adjuvant immunotherapy	neoadjuvant chemoradiotherapy and perioperative toripalimab

Primary Outcome Measures

Name	Time	Method
pathologically complete response(pCR)	From date of surgery to 4 weeks later	absence of viable tumor cells in the resected cancer specimen（ypT0N0）

Secondary Outcome Measures

Name	Time	Method
event free survival	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.

Trial Locations

Locations (1)

Radiation Oncology Department, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China