Neoadjuvant Chemoradiotherapy Followed by Sequential Immunotherapy for Thoracic Esophageal Squamous Cell Carcinoma

Обзор

The purpose of study is to investigate the safety and efficacy of sequential immunotherapy with neoadjuvant chemoradiotherapy for esophageal cancer

Подробное описание

This is a single-arm, phase Ib study. Eligibility criteria include histologically confirmed ESCC and clinical T3-4aN0M0 or T2-4aN+M0 (AJCC/UICC 8). Patients received neoadjuvant radiotherapy (41.4Gy in 23 fractions) with concurrent chemotherapy (paclitaxel, 50 mg/m2, carboplatin area under the curve of 2mg/mL/min, QW\*5). Then followed by two cycles of tislelizumab (200mg, Q3W). The primary endpoint was the pathological complete response (pCR) rate and safety.

Вмешательства

• Препарат paclitaxel
  paclitaxel, 50 mg/m2, QW\*5
• Препарат carboplatin
  area under the curve of2mg/mL/min, QW\*5
• Препарат tislelizumab
  200mg Q3W, 2cycles
• Лучевая терапия radiotherapy
  41.4Gy in 23 fractions

Первичные конечные точки

• Complete pathological response rate [Срок оценки: 1 year]

Вторичные конечные точки (4)

• R0 resection rate [Срок оценки: 1 year]
• 2-year Disease-free survival rate [Срок оценки: 2 years]
• 2-year overall survival rate [Срок оценки: 2 years]
• Safety will be analyzed through the incidence of adverse events, serious adverse events [Срок оценки: Up to 28 days from last dose]

Критерии участия

Критерии включения

• Ages 18-75.
• Histology confirmed thoracic esophageal squamous cell carcinoma.
• ECOG ps 0 to 1.
• Resectable or potentially resectable T2-4aN0 or T1-4aN+ patients (AJCC/UICC Clinical Staging of Esophageal squamous cell Carcinoma, 8th edition (cTMN)).
• Length of esophageal lesions <8cm.
• There were no surgical contraindications.
• Neutrophil count ≥1.5\*109/L, platelet count ≥10.0\*109/L, hemochrome ≥9g/dL; Serum creatinine ≤1.5 times the upper limit of normal value; Bilirubin ≤1.5 times the upper limit of normal value, AST, ALT, AKP≤2.5 times the upper limit of normal value.
• BMI acuity 18.5 kg/m2.
• Informed notification and signed informed consent.

Критерии исключения

• Cervical esophageal cancer (upper part of the lesion in the cervical esophagus). Multifocal esophageal carcinoma, lesion length >8cm.
• Trachea and aorta were invaded (Annex 5).
• Hoarseness caused by the tumor.
• Esophageal fistula.
• Lymph node metastasis in the neck and periceliac artery (AJCC/UICC 8th edition esophageal/esophagogastric junction region lymph node division 1 and 20).
• A history of active autoimmune disorders or syndromes requiring treatment with systemic steroids or immunosuppressants (except for vitiligo or cured childhood asthma/allergies who do not require any intervention in adulthood; Autoimmune hypothyroidism treated with a stable dose of thyroid replacement hormone).
• She is on hormonal or immunosuppressive therapy.
• He's had an organ transplant.
• HIV infection, hepatitis C (hepatitis C antibody positive with HCV-RNA above the detection limit of the assay), chronic active hepatitis B (HBV DNA≥2×103IU/ml or >1×104copies/mL).
• Active tuberculosis, interstitial pneumonia, active infection, poorly controlled diabetes, symptomatic arrhythmia, symptomatic new dysfunction, myocardial infarction, active peptic ulcer, chronic active enteritis within 6 months; Affected during pregnancy or lactation.
• Major surgery in the last three months.
• Severe diabetes mellitus with poor drug control, symptomatic arrhythmia, symptomatic cardiac insufficiency, myocardial infarction within 6 months, chronic active enteritis, chronic nephritis. QTc acuity 470 ms.
• He had a history of malignancy. Previously received chemotherapy, radiotherapy, targeted therapy, immunotherapy and other antitumor therapies.
• Patients with allergic or contraindicated taxa.
• Live vaccine is administered within 30 days before the first dose of immunotherapy.
• Refusal or inability to sign up for ICF study.
• The investigator decided that the patient was not suitable to participate.

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

• Zhejiang Cancer Hospital — Ханчжоу

Идентификаторы

NCT: NCT06303583 · IRB- 2022-213

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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