A Single-arm, Open, Single-center Exploratory Study of Adebrelimab (SHR-1316) in Combination With Chemotherapy for the Perioperative Treatment of Locally Advanced Resectable Esophageal Squamous Carcinoma

Обзор

This study is a prospective, observational clinical study. In this study, 30 patients with resectable locally advanced esophageal squamous carcinoma will be prospectively enrolled and treated with adebrelimab (SHR-1316) combined with nab-paclitaxel and cisplatin preoperatively and adebrelimab (SHR-1316) single-agent adjuvant therapy postoperatively, to observe the efficacy and safety of this treatment modality, and to provide clinical evidence for the use of PD-L1 monoclonal antibody in perioperative treatment of esophageal cancer.

Вмешательства

• Препарат Adebrelimab (SHR-1316) + Nab-paclitaxel + Cisplatin
  All subjects were given 3 cycles of neoadjuvant therapy with adebrelimab (1200 mg D1, IV, Q3W)+Nab-paclitaxel(250 mg/m2 D1，IV，Q3W)+Cisplatin(75 mg/m2 D1，IV，Q3W) preoperatively. Within 4-8 weeks of completion of neoadjuvant therapy, all subjects who were suitable for surgery underwent radical surgery, and patients who underwent radical esophageal cancer with R0 resection were given adebrelimab monotherapy postoperatively until disease recurrence or metastasis, toxicity intolerance, initiation of

Первичные конечные точки

• Pathologic complete response rate (pCR) [Срок оценки: Three weeks after surgery of last enrolled subject. Estimate up to 2 years]
• Adverse Events (AE) [Срок оценки: about 2 years]

Вторичные конечные точки (7)

• R0 resection rate [Срок оценки: Three weeks after surgery of last enrolled subject. Estimate up to 2 years]
• Major pathologic response rate [Срок оценки: Three weeks after surgery of last enrolled subject. Estimate up to 2 years.]
• Objective Response Rate [Срок оценки: Estimate up to 2 years]
• Event-free survival (EFS) [Срок оценки: Estimate up to 2 years]
• 1-year event-free survival rate (1-year EFS) [Срок оценки: Estimate up to 2 years]
• Disease-free survival (DFS) [Срок оценки: about 2 years]
• 1-year disease-free survival rate (1-year DFS) [Срок оценки: about 2 years]

Критерии участия

Критерии включения

• Aged 18-75 years old, regardless of gender；
• Surgically resectable locally advanced squamous cell carcinoma of the esophagus confirmed by histology or cytology (pre-treatment clinical stage cT1b-cT2, N+ or cT3-cT4a, ANY N according to the 8th edition of AJCC staging);
• Presence of measurable and/or non-measurable lesions as defined by the criteria for evaluating the efficacy of solid tumors (RECIST v1.1);
• No prior antitumor therapy for esophageal cancer, including chemotherapy, radiotherapy (including planned radiotherapy during the study period), hormone therapy, and immunotherapy;
• ECOG PS 0 to 1 point;
• No contraindication to surgery as evaluated by various organ function tests;
• Prior to treatment, the following laboratory tests to confirm that bone marrow, liver and kidney function meet the requirements for participation in the study (requiring no blood transfusion or use of hematopoietic stimulating factors (including G-CSF, GM-CSF , EPO, and TPO, etc.) within 14 days prior to screening):

• Hemoglobin ≥ 90 g/L;
• White blood cell count ≥ lower limit of laboratory normal;
• Absolute neutrophil count (ANC) ≥ 1.5 × 109/L;
• Platelet count ≥100×109/L;
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN);
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN;
• Prothrombin time ≤ 16 seconds and International Normalized Ratio (INR) ≤ 1.5 x ULN;
• Creatinine ≤ 1.5 x ULN and Cr clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula);
• Must understand and voluntarily sign an informed consent form.

Критерии исключения

• malignant tumors other than esophageal cancer within 5 years prior to enrollment (cured limited tumors are not excluded, including cervical carcinoma in situ, basal cell carcinoma of the skin, and carcinoma in situ of the prostate gland; patients with prostate cancer who received hormone therapy and obtained DFS for more than 5 years are not excluded)；
• Comorbid serious cardiac and cerebrovascular diseases:

• Congestive heart failure, unstable angina, myocardial infarction, poorly controlled arrhythmia, or cerebrovascular accident of New York Heart Association (NYHA) class II or higher within 12 months prior to enrollment.
• Medication-uncontrolled hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg) (based on the average of ≥2 measurements)
• Previous hypertensive crisis or hypertensive encephalopathy
• Prior history of interstitial lung disease or pneumonia requiring steroid therapy at enrollment；
• Have a blood-borne infectious disease, including, but not limited to, hepatitis B virus carrier, hepatitis C, syphilis, or HIV;
• Previous severe allergy to chemotherapeutic agents (paclitaxel or carboplatin) or to any of the monoclonal antibodies;
• Active autoimmune disease requiring systemic therapy (i.e., immunomodulatory drugs, corticosteroid drugs, or immunosuppressive drugs) within the past 2 years; however, alternative therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered systemic and are permitted and enrollment is allowed;
• Women during pregnancy;
• Patients who, in the opinion of the investigator, are not suitable for participation in this study, based on a comprehensive assessment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University Cancer Hospital — Пекин

Идентификаторы

NCT: NCT06869213 · 2024KT157

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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