Induction Tislelizumab Combined With Chemotherapy Followed by Definitive Chemoradiotherapy in the Treatment of Locally Unresectable Esophageal Squamous Cell Carcinoma

Обзор

To explore the efficacy of Tislelizumab combined with chemotherapy in the treatment of locally unresectable esophageal squamous cell carcinoma (ESCC)

Вмешательства

• Препарат Tislelizumab
  Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks
• Препарат Albumin paclitaxel
  Participants will receive Albumin paclitaxel 260 mg/m2 , day 1 of every 3 weeks
• Препарат Nedaplatin
  Participants will receive Nedaplatin 80 mg/m2 , day 1 of every 3 weeks
• Лучевая терапия radiotherapy
  50-60Gy/25-30f

Первичные конечные точки

• progression free survival [Срок оценки: up to 24 months]

Вторичные конечные точки (2)

• Objective Response Rate (ORR) [Срок оценки: every 6 weeks （up to 24 months）]
• Overall survival (OS) [Срок оценки: every 3 months (up to 24 months)]

Критерии участия

Критерии включения

• Histologically confirmed localized ESCC that is suitable for cCRT, including: stage II-IVA (AJCC version 8) inoperable ESCC (medically unfit for surgery or refusing surgical intervention);;
• Aged 18-70, both sexes;
• ECOG score 0-1
• The presence of measurable and/or nonmeasurable lesions that met the definition of RECIST1.1;
• Adequate organ and bone marrow function, meeting the following definitions:

• Blood routine (no blood transfusion, no granulocyte colony-stimulating factor \[G-CSF\], and no other drugs were used within 14 days before treatment);Absolute neutrophil count (ANC) ≥1.5×109/L;Hemoglobin (HB) ≥9.0 g/dL;Platelet count (PLT) ≥100×109/L;
• Blood biochemistry Creatinine clearance rate ≥60 mL/min;Total bilirubin (TBIL) ≤ 1.5×ULN;Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤2.5×ULN;
• Expected survival time > 6 months;
• Fertile female subjects and male subjects with partners of reproductive age are required to use a medically approved contraceptive method during the study treatment period and for at least 3 months after the last treatment;
• Patients who volunteered to participate in this study and signed the informed consent form.

Критерии исключения

• A history of fistula caused by primary tumor invasion;
• Presence of clinically uncontrolled pleural effusion, pericardial effusion, or ascites that required repeated drainage or medical intervention (within 2 weeks before randomization);
• Known intolerance or resistance to chemotherapy specified in the trial protocol;
• have received any other ESCC antitumor therapy (e.g., therapy targeting PD-1, PD-L1, PD-L2 or other tumor immunotherapy, radiotherapy, targeted therapy, ablation or other systemic or local antitumor therapy);
• Patients with active autoimmune disease or a history of autoimmune disease that may relapse, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• History of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including pulmonary fibrosis and acute lung disease;
• Severe chronic or active infection (including tuberculosis infection) requiring systemic antimicrobial therapy, antifungal therapy or antiviral therapy before enrollment;
• Known history of HIV infection;
• Other malignancies (except cured basal cell carcinoma of the skin, carcinoma in situ of the breast and carcinoma in situ of the cervix) in the past 5 years;
• Received live vaccine within 28 days before enrollment;
• while participating in another therapeutic clinical trial.

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

• Ye zai sheng — Фучжоу

Идентификаторы

NCT: NCT05515315 · TPT-ESCC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗