Nimotuzumab Concurrent With Chemoradiotherapy for Patients With Unresectable Esophageal Squamous Cell Carcinoma

Официальное название

Nimotuzumab Concurrent With Chemoradiotherapy for Patients With Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma After Failure of Chemotherapy：A Phase II Study

Обзор

Patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) who failed to induction chemo(immuno)therapy had poor prognosis. Radiotherpy was an important and effective treatment in treating ESCC. The present study is a one-arm trial that seeks to evaluate the efficacy in patients with unresectable ESCC. The study objectives include R0 resection rate, complete pathological response and treatment toxicity, etc. Nimotuzumab is a recombinant humanized monoclonal antibody against EGFR. Its efficacy and safety in patients with esophageal cancer have been confirmed by many studies. The current prospective phase II study aimed to evaluate the efficacy and safety of a combination regimen comprising chemotherapy with nimotuzumab and S-1 and concurrent radiotherapy for patients who are not sensitive to induction chemo(immuno)therapy.

Вмешательства

• Комбинированный продукт Nimotuzumab with chemoradiotherapy
  Radiotherapy, 40-50.4Gy/20-28f. Nimotuzumab 400mg, ivgtt, W2d. Chemotherapy, S-1, 40-60mg/m2, on BSA，orally twice daily on radiotherapy days.

Первичные конечные точки

• R0 resection rate [Срок оценки: 4 months after initiation of induction chemoimmunotherapy]

Вторичные конечные точки (5)

• Pathological complete response [Срок оценки: 4 months after initiation of induction chemoimmunotherapy]
• Event-free survival [Срок оценки: 1 year after all treatment]
• Side effects during chemoradiotherpay [Срок оценки: 1 month after chemoradiotherapy]
• Postoperative complications [Срок оценки: 1 month after surgery]
• Overall survival [Срок оценки: 1 year after all treatment]

Критерии участия

Критерии включения

• Histologically confirmed esophageal squamous cell carcinoma. Tumor response was evaluated as stable or locoregionally progresive disease or assessed by surgeons being unresectable (without distant metastasis) after induction chemo(immuno)therapy.
• Cycles of induction chemo(immuno)therapy was 2-4.
• KPS score ≥70.
• Main organs and bone marrow function are normal: routine blood tests: hemoglobin (Hb) ≥100g/L ; absolute neutrophil count (NEUT)≥1.5×109/L; platelets (PLT) ≥100×109/L; white blood cell (WBC)≥3.5×109/L,biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×UNL; serum total bilirubin (TBIL) ≤1.5×UNL; serum creatinine ( Cr) 1.0×1.5UNL, and BUN≤1.0×UNL;

Критерии исключения

• Those combined with other primary malignant tumors other than esophageal cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
• At the time of diagnosis, there were distant and hematogenous metastases beyond the supraclavicular lymph node region, including retroperitoneal multiple lymph node metastasis, bone metastasis, brain metastasis, lung metastasis, liver metastasis, malignant pleural effusion and ascites
• There are active infections, such as active tuberculosis and hepatitis
• There are contraindications to targeted therapy.

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

• National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chine — Пекин

Идентификаторы

NCT: NCT06410651 · NCC4536

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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