Clinical trial NCT06762158: NCRT Combined With Sequential Perioperative PD-1 Inhibitor for LAESCC
Official title: Neoadjuvant Chemoradiotherapy Combined With Sequential Perioperative PD-1 Inhibitor for Locally Advanced Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Esophageal Squamous Cell Carcinoma (ESCC)
Keywords: esophageal squamous cell cancer
neoadjuvant chemoradiotherapy
perioperative immunotherapy
PD-1 inhibitor
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: pathologically complete response(pCR)
timeFrame: From date of surgery to 4 weeks later
Secondary outcomes:
measure: event free survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Radiation Oncology Department, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: