A Prospective, Randomized Controlled Study to Evaluate the Efficacy and Safety of Durvalumab Combined With Neoadjuvant Therapy in Patients With Local Advanced Esophageal Squamous Cell Carcinoma

69152630

This is a study to evaluate the efficacy and safety of preoperative treatment with durvalumab combined with neoajuvant therapy (carboplatin, paclitaxel with/without radiation) in locally advanced resectable oesophageal squamous carcinoma.

2020-06-19

2023-12-01

2024-01-01

Completed

Early phase I

60

Inclusion Criteria: * Histologically proven squamous cell carcinoma of the esophagus. * Surgical resectable (T3 or T4b, N0 or N+, M0), as determined by Endoscopic Ultra Sound (EUS),PET/CT, Esophageal MRI and enhanced CT scan of neck, thorax and abdomen. * Tumor length longitudinal ≤ 10 cm; if larger than 10 cm, inclusion should be discussed with the principal investigator. * 18≤Age≤75. * Tumor does not involve gastro-esophageal junction. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate hematological, renal and hepatic functions defined as: neutrophiles ≥ 1.5 x 109/L platelets ≥ 100 x 109/L alanine transaminase≤2 x upper normal limit hemoglobin ≥ 5.6 mmol total bilirubin ≤ 1.5 x upper normal limit creatinine clearance (Cockroft) ≥60 ml/min * Written, voluntary informed consent. Exclusion Criteria: * Past or current history of malignancy other than entry diagnosis interfering with prognosis of esophageal cancer. * T1, T2 tumors or in situ carcinoma. * metastatic oesophageal cancer. * Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation. * Previous chemotherapy, radiotherapy, and/or treatment with checkpoint inhibitors. * Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) precluding major surgery. * Pulmonary fibrosis and/or severely impaired lung function precluding major surgery. * Pre-existing motor or sensory neurotoxicity greater than WHO grade 1. * Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (\>10 mg/day prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. * Dementia or altered mental status that would prohibit the understanding and giving of informed consent * Serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing Cremophor, such as teniposide or cyclosporine. * Has an active infection requiring systemic therapy which has not resolved 3 days (simple infection such as cystitis) to 7 days (severe infection such as pyelonephritis) prior to the first dose of trial treatment. * Has a diagnosis of acute or chronic hepatitis B, hepatitis C, known immunodeficiency or human immunodeficiency virus (HIV). * Patients with prior allogeneic stem cell or solid organ transplantation.

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2024-01-22