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Набор скоро начнётся NCT07297030

SIB-RT Combined With CAPOX and PD-1 for High-Risk Rectal Cancer

Фаза II С лечением 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: SIB-SCRT, CAPOX, Immunotherapy.
Кому может быть актуально
Состояния в реестре: Rectal Cancer. Базовые параметры: 18 лет — 75 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

A Prospective Single-Arm Phase II Clinical Study of Neoadjuvant Short-Course Radiotherapy With Simultaneous Integrated Boost Combined With Capecitabine-Oxaliplatin and PD-1 Inhibitor Therapy in High-Risk Locally Advanced Rectal Cancer

Обзор

The biological effective dose of short-course radiotherapy is relatively lower compared to long-course radiotherapy, which may lead to an increased local recurrence rate in patients with mid to low rectal cancer who are at high risk of locally advanced disease due to insufficient radiation dose. Combining short-course radiotherapy with simultaneous integrated boost (SIB) and immunotherapy-chemo regimens could potentially further enhance tumor regression and improve local control, providing a promising treatment option for high-risk locally advanced rectal cancer patients. Therefore, this clinical trial aims to explore the safety and effectiveness of a short-course SIB radiotherapy regimen combined with immunotherapy and chemotherapy as neoadjuvant treatment for locally advanced rectal cancer, based on short-course radiotherapy combined with chemotherapy and immunotherapy.

Вмешательства

  • Лучевая терапия SIB-SCRT
    The pelvic lymphatic drainage regions receive 25 Gy in 5 fractions (5 Gy per fraction). A ssequential boost to a total dose of 30 Gy in 6 fractions is delivered to the primary tumour and any radiologically suspicious lymph nodes.
  • Препарат CAPOX
    * Oxaliplatin 130 mg/m² intravenously on day 1. * Capecitabine 1,000 mg/m² orally twice daily on days 1-14.
  • Препарат Immunotherapy
    \- Tislelizumab 200 mg intravenously on day 1.

Первичные конечные точки

  • The Complete Response (CR) rate [Срок оценки: 3 months]
Вторичные конечные точки (6)
  • Rate of ≥Grade 3 toxicities [Срок оценки: 3 months]
  • 3-Year Disease-Free Survival Rate (3yDFS%) [Срок оценки: 3 years]
  • 3-Year Locoregional Recurrence-Free Survival Rate (3yLRFS%) [Срок оценки: 3 years]
  • 3-Year Overall Survival Rate (3yOS%) [Срок оценки: 3 years]
  • Surgical Complications [Срок оценки: 6 months]
  • Quality of Life (QoL) [Срок оценки: 3 years]

Критерии участия

Критерии включения

  • Participants must voluntarily agree to join this study and sign an informed consent form.
  • Age at the time of signing the informed consent form must be between 18 and 75 years.
  • Histologically confirmed diagnosis of rectal adenocarcinoma.
  • High-risk locally advanced pMMR/MSS rectal cancer, categorized according to the AJCC/UICC 8th edition clinical staging and in reference to the inclusion criteria of the RAPIDO study, must meet at least one of the following conditions: cT4 stage, cN2 stage, involvement of the mesorectal fascia (MRF), or presence of laterally enlarged lymph nodes, with M0 status.
  • The inferior margin of the tumor must be ≤10 cm from the anal verge.
  • No prior anti-cancer treatment for rectal cancer (including local-regional and systemic therapy).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.
  • At least one measurable lesion according to RECIST v1.1 criteria.
  • Normal function of major organs without severe abnormalities in hematological, cardiovascular, pulmonary, hepatic, renal, or bone marrow function; laboratory tests must meet the following requirements:

Hemoglobin (Hb) ≥ 70 g/L; White blood cell count (WBC) ≥ 3.0 × 10\^9/L; Neutrophil count (NEUT) ≥ 1.5 × 10\^9/L; Platelet count (PLT) ≥ 100 × 10\^9/L; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times the upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Renal function (serum creatinine, sCr) level ≤ 1.5 times the upper limit of normal (ULN).

Критерии исключения

  • Evidence of distant metastasis.
  • Recurrent rectal cancer.
  • Documented allergy to the investigational drug and/or its excipients.
  • Contraindications to radiotherapy and/or chemotherapy.
  • Women who are pregnant or breastfeeding.
  • A history of other malignancies.
  • Patients who have participated in other clinical trials involving investigational drugs within the last 6 months.
  • Patients deemed inappropriate for inclusion in this study as determined by the investigator.

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
  • Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University — Гуанчжоу

Идентификаторы

NCT: NCT07297030 · GIHSYSU-38

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗