TDLN-sparing RT Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced ESCC

Launched by FUDAN UNIVERSITY · May 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally advanced esophageal squamous cell cancer (ESCC). The researchers want to find out if a type of radiotherapy that spares certain lymph nodes, followed by a medication that boosts the immune system (called PD-1 inhibitor), can help treat this cancer. The trial is currently looking for adult participants aged 18 and older who have been diagnosed with this type of cancer and meet specific health criteria.

To be eligible, participants should have a good performance status, meaning they can carry out daily activities with minimal limitations, and must be expected to live for at least three months. Some health conditions, such as active autoimmune diseases or certain heart issues, may prevent individuals from joining the study. If you decide to participate, you will receive the new treatment and will be monitored closely by the medical team for your safety and well-being throughout the trial. This is a great opportunity to contribute to important research that could lead to better treatment options for others with ESCC.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent
• • 2. Aged 18 years or above
• • 3. Histologically confirmed esophageal squamous cell carcinoma
• • 4. 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 Criteria:
• • 1. Esophageal perforation or hematemesis
• • 2. 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).
• • 3. Previously received or receiving PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1.
• • 4. Allergic to any of the ingredients in PD-1 inhibitors for injection.
• • 5. 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.
• • 6. 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.
• • 7. 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.
• • 8. 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.