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

RenJi Hospital1 site in 1 country50 target enrollmentOctober 30, 2024

ConditionsEsophageal Squamous Cell Carcinoma (ESCC)

Interventionsadjuvant immunotherapy Neoadjuvant Chemoradiotherapy neoadjuvant immunotherapy Surgery

Drugsneoadjuvant immunotherapy adjuvant immunotherapy

Overview

Phase: N/A
Intervention: adjuvant immunotherapy
Conditions: Esophageal Squamous Cell Carcinoma (ESCC)
Sponsor: RenJi Hospital
Enrollment: 50
Locations: 1
Primary Endpoint: pathologically complete response(pCR)
Status: Active, Not Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 30, 2024

End Date

December 1, 2029

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

RenJi Hospital

Responsible Party

Sponsor

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