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NCRT Combined With Sequential Perioperative PD-1 Inhibitor for LAESCC | Clinical Trials | Clareo Health

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NCRT Combined With Sequential Perioperative PD-1 Inhibitor for LAESCC

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

NCT06762158•RenJi Hospital

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

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

Locations (1)

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

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

October 30, 2024

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2029

Last Updated

January 7, 2025

Enrollment

ESTIMATED participants

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

Neoadjuvant Chemoradiotherapy

RADIATION

neoadjuvant immunotherapy

DRUG

Surgery

PROCEDURE

adjuvant immunotherapy

DRUG

MR-Guided Radiotherapy Dose Escalation Trial for Esophageal Squamous Cell Carcinoma

NCT07359417

Esophageal Squamous Cell Carcinoma (ESCC)Esophageal Cancer, Squamous Cell

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RECRUITINGPHASE1/PHASE2

A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies

NCT05473156

Locally Advanced or Metastatic Solid TumorsNon Small Cell Lung Cancer (NSCLC)+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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NCRT Combined With Sequential Perioperative PD-1 Inhibitor for LAESCC

Inclusion Criteria

Exclusion Criteria

MR-Guided Radiotherapy Dose Escalation Trial for Esophageal Squamous Cell Carcinoma

A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies

A Phase II Clinical Study of Sintilimab Combined with Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC) (NICE-CS)

Tumor Regression Grade As Predictor of Adjuvant Therapy

Immunochemotherapy ± Salvage Chemoradiation for Local Recurrence of Esophageal Squamous Cell Carcinoma After Definitive Chemoradiotherapy

Intestinal Low-Dose Radiotherapy Plus Immunochemotherapy for Conversion of Borderline Resectable/Unresectable Esophageal Squamous Cell Carcinoma