NCRT Combined With Sequential Perioperative PD-1 Inhibitor for LAESCC

Shanghai Jiao Tong University

Status

Active, not recruiting

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Treatments

Procedure: Surgery

Radiation: Neoadjuvant Chemoradiotherapy

Drug: adjuvant immunotherapy

Drug: neoadjuvant immunotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06762158

LY2024-217-A

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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