Status:
RECRUITING
TDLN-sparing RT Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced ESCC
Lead Sponsor:
Fudan University
Conditions:
Esophageal Carcinoma
Radiotherapy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The goal of this clinical trial is to learn if tumor draining lymph nodes-sparing radiotherapy (TDLN-sparing RT) followed by immunotherapy as maintenance therapy works to treat locally advanced esopha...
Eligibility Criteria
Inclusion
- Written informed consent
- Aged 18 years or above
- Histologically confirmed esophageal squamous cell carcinoma
- Clinical stages T3-4N0M0 or TxN+M0 or TxNxM1 (Only for supraclavicular lymph nodes) based on the 8th UICC-TNM classification
- 7\. Eastern Cooperative Oncology Group(ECOG) performance status: 0-1 8. Life expectancy ≥3 months 9. Adequate organ functions Absolute neutrophil counts (ANC) ≥1.5×109⁄L; Hemoglobin (Hb) ≥9g⁄dl; Platelet (Plt) ≥100×109⁄L; Total bilirubin ≤1.5 upper limit of normal (ULN); Aspartate transaminase (AST) ≤2.5 ULN; Alanine aminotransferase (ALT) ≤2.5 ULN; Creatinine ≤1.5 ULN
Exclusion
- Esophageal perforation or hematemesis
- Any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism and hypothyroidism (effective hormone replacement therapy excepted)) and immunosuppressive agents or systemic hormonal therapy indicated within 28 days (for adverse events of chemoradiotherapy excepted).
- Previously received or receiving PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1.
- Allergic to any of the ingredients in PD-1 inhibitors for injection.
- Uncontrolled heart diseases or clinical symptoms, such as: (1) New York Heart Association(NYHA) class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4)clinically significant arrhythmia requiring clinical intervention.
- Congenital or acquired immunodeficiency (such as HIV infection); active hepatitis B (HBV-DNA≥104 copy number/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method); active tuberculosis.
- Active infection or unexplained fever \>38.5 °C within 2 weeks before randomization (fever due to tumor excepted, according to investigator).
- Patients with fertility reluctant to take contraceptive measures during the trial, or female patients pregnant or breastfeeding.
- According to the investigator, other factors that may cause termination of the study. ie, other serious diseases (including mental illness) require combined treatment, family or social factors, which may affect the safety or the collection of trial data.
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2031
Estimated Enrollment :
452 Patients enrolled
Trial Details
Trial ID
NCT06964568
Start Date
February 1 2025
End Date
February 1 2031
Last Update
January 7 2026
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China