TDLN-sparing RT Plus Immunotherapy and Chemotherapy in Locally Advanced ESCC

Launched by FUDAN UNIVERSITY · Nov 5, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to find out if a combination of immunotherapy, a type of treatment that helps the immune system fight cancer, along with a special kind of radiation therapy that spares certain lymph nodes (called TDLN-sparing radiotherapy) and chemotherapy is more effective for treating locally advanced esophageal squamous cell carcinoma, a type of throat cancer. Researchers will compare this combination to just the radiation and chemotherapy to see which treatment works better.

To join the trial, participants need to be adults aged 18 to 75 with a confirmed diagnosis of this type of esophageal cancer, and their condition should be at certain stages as defined by medical guidelines. They should also be generally healthy enough to tolerate treatment. Participants can expect to receive radiation therapy along with chemotherapy, and some will also receive immunotherapy, which is given every three weeks for a year. The study is currently recruiting participants, and those who volunteer will help researchers learn more about improving treatment for this challenging cancer.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent
• • 2. Aged 18-75 years
• • 3. Histologically confirmed esophageal squamous cell carcinoma
• • 4. Clinical stages T3-4N0M0 or TxN1M0 or TxNxM1a or TxNxM1b (Only for cervical lymph nodes or celiac lymph nodes metastasis) based on the 6th 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 macromolecular protein preparations, or 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).
• • 8. Patients with fertility reluctant to take contraceptive measures during the trial, or female patients pregnant or breastfeeding.
• • 9. 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.