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Идёт набор NCT07448077

Short-course Radiotherapy in TNT Combined With Enlonstobart for pMMR LARC

Фаза II С лечением Efficacy and Safety of Short-course Radiotherapy in Total Neoadjuvant Therapy Combined With Enlonstobart for pMMR Locally Advanced Rectal Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Experimental: short-course radiotherapy and immunotherapy, Chemoradiotherapy.
Кому может быть актуально
Состояния в реестре: Efficacy and Safety of Short-course Radiotherapy in Total Neoadjuvant Therapy Combined With Enlonstobart for pMMR Locally Advanced Rectal Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Short-Course Radiotherapy in Total Neoadjuvant Therapy Combined With Enlonstobart for pMMR Locally Advanced Rectal Cancer: A Prospective, Multicenter, Open-Label, Randomized Controlled Trial

Обзор

Efficacy and safety of short-course radiotherapy in total neoadjuvant therapy combined with enlonstobart for pMMR locally advanced rectal cancer

Вмешательства

  • Препарат Experimental: short-course radiotherapy and immunotherapy
    patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and Enlonstobart Enlonstobart 200mg IV every 3 weeks; Oxaliplatin 130mg/m2 IV Q3W d1 Capecitabine 1000mg/m2 bid d1-14 q3w
  • Препарат Chemoradiotherapy
    Long-course radiotherapy +Capecitabine 825mg/m2 bid d1-d14, followed by 4 cycles of CAPOX chemotherapy

Первичные конечные точки

  • complete response Rate (pCR+cCR ) [Срок оценки: up to 2 year]
Вторичные конечные точки (5)
  • Major pathologic response rate [Срок оценки: up to 2 year]
  • R0 resection rate [Срок оценки: The R0 resection rate will be evaluated after surgery, an average of 4 weeks]
  • 3-year event-free survival (EFS) rate [Срок оценки: up to 3 years]
  • 3-year overall survival (OS) [Срок оценки: up to 3 years]
  • Adverse Event [Срок оценки: up to 2 year]

Критерии участия

Критерии включения

  • 1.age >=18 years old, female and male. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 3.Histologically confirmed adenocarcinoma of the colon, and umor biopsy immunohistochemistry (IHC) indicates pMMR .

4.Staged as T3-4 NanyM0 or T1-2N+ M0 according to the AJCC 8th edition. 5.Rectal cancer: <10 cm from the anal verge. 6.Adequate organ function:

  • Hematology : i. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L. ii. Platelet count ≥ 100 × 10⁹/L . iii. Hemoglobin ≥ 90 g/L.
  • Hepatic: i. Serum Total Bilirubin (TBil) ≤ 1.5 × ULN (Upper Limit of Normal). ii. AST and ALT ≤ 2.5 × ULN. iii. Creatinine ≤ 1.5 × ULN ; Renal: Calculated Creatinine Clearance (CrCl) ≥ 60 mL/min (calculated using the Cockcroft-Gault formula)
  • Coagulation: i. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.

7\. Men and women of childbearing potential must agree to use effective contraceptive measures during the study and for 6 months after the last treatment.

8\. Willing and able to voluntarily provide written informed consent and comply with all scheduled treatments and follow-up assessments.

Критерии исключения

  • Pathological diagnosis of other special types, including but not limited to neuroendocrine carcinoma or squamous cell carcinoma.
  • Has previously received radiotherapy, targeted agents, or immune checkpoint inhibitors for the treatment of rectal cancer.
  • Active autoimmune disease, such as systemic lupus erythematosus or rheumatoid arthritis, necessitating ongoing immunosuppressive treatment.
  • Has active infection, including but not limited to HIV, or positive HBV/HCV viral load requiring antiviral therapy for control and stabilization.
  • Significant cardiovascular disease, such as myocardial infarction within 6 months prior to enrollment, unstable angina pectoris, or hypertension that remains uncontrolled above 160/100 mmHg despite optimal therapy.
  • History of other malignant tumors, excluding non-melanoma skin cancer and cervical carcinoma in situ that have been curatively treated and disease-free for ≥ 5 years.
  • Uncontrolled diabetes (HbA1c > 8%) or thyroid dysfunction requiring medication for abnormal TSH.
  • Severe chronic intestinal conditions，including but not limited to Crohn's disease or active ulcerative colitis.
  • The investigators believe that patients were inappropriate for participation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Hebei Medical University Fourth Hospital — Shijiazhuang

Идентификаторы

NCT: NCT07448077 · CSPC-ESX-CRC-K01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗