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Идёт набор NCT07561060

Low Rectal Cancer Treated With Total Neoadjuvant Therapy Plus Concurrent Tislelizumab Immunotherapy

Фаза I / 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: Tislelizumab, Capecitabine, Oxaliplatin, Capecitabine.
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 Single-arm, Multicenter, Phase II Clinical Study of Total Neoadjuvant Therapy Plus Concurrent Tislelizumab Immunotherapy in Resectable Low Rectal Cancer

Обзор

This is an open-label, multi-center, single-arm clinical study. All patients received 4-6 cycles total neoadjuvant therapy plus concurrent tislelizumab immunotherapy, then underwent clinical response assessment. Patients who achieved CR (cCR+ pCR confirmed by local resection of ncCR) continue tislelizumab combined with CAPOX for another 4 cycles and tislelizumab for 9 cycles, then Watch and Wait. Patients who did not achieved CR underwent total mesorectal excision (TME).

Вмешательства

  • Препарат Tislelizumab
    200 mg IV on Day 1 of each 21-day cycle.
  • Препарат Capecitabine
    Capecitabine 1000 mg/m2 orally twice daily (bid) on Day 1 to 14 of each 21-day cycle in CAPOX regimen
  • Препарат Oxaliplatin
    130 mg/m2 IV on Day 1 of each 21-day cycle in CAPOX regimen
  • Препарат Capecitabine
    825 mg/m2 orally twice daily (bid) 5 days/week during radiotherapy.

Первичные конечные точки

  • Complete Response rate (CR rate) [Срок оценки: From first dose up to 12 months, approximately]
Вторичные конечные точки (4)
  • 1/2/3 year organ-preservation rate [Срок оценки: From first dose of radiotherapy up to 36 months, approximately]
  • 1/2/3 year EFS rate [Срок оценки: From first dose of radiotherapy up to 36 months, approximately]
  • 1/2/3 year OS rate [Срок оценки: From first dose of radiotherapy up to 36 months, approximately]
  • Percentage of Participants With Adverse Events [Срок оценки: From first dose of radiotherapy up to 36 months, approximately]

Критерии участия

Критерии включения

  • Able to provide written informed consent, understand and comply with the requirements and evaluation schedule
  • ≥18, ≤75 years old
  • Histologically confirmed rectal adenocarcinoma
  • immunohistochemistry confirmed pMMR (positive for MLH1, MSH2, MSH6 and PMS2), or PCR /NGS confirmed MSI-L or MSS
  • The tumor is within 3 cm of the dentate line. through colonoscopy, digital anal examination or MRI
  • clinical stage cT1-3 N 0-1M0 (the 8th UICC/AJCC; T and N is evaluated by MRI)
  • Resectable primary tumor assessed by the Investigator
  • Have not received any anti-tumor treatment for rectal cancer
  • ECOG PS ≤ 1
  • Adequate organ function
  • Female subjects with the ability to become pregnant must have a serum pregnancy test with a negative result within 72 hours before the first dose, and be willing to use highly effective contraceptive methods during the trial and 120 days after the last dose. Male subjects whose partners are women of childbearing potential should be surgically sterilized or agree to use a highly effective method of contraception during the trial and for 120 days after the last dose.

Критерии исключения

  • Histologically confirmed poorly differentiated/undifferentiated adenocarcinoma, mucinous adenocarcinoma and signet ring cell carcinoma
  • Have received any treatments for rectal cancer, or evidence of distant metastasis
  • Presence of following high risk factors assessed by MRI: MRF +, EMVI+, cN2, Positive lateral lymph nodes, T3d
  • Presence or in high risk of obstruction, perforation or bleeding;
  • Not suitable for long-course radiotherapy
  • Cannot tolerate surgery
  • ≥2 colorectal cancer lesions at the same time
  • Contraindications for MRI examination
  • Other malignant tumors in the past or at the same time
  • Have an active autoimmune disease requiring systemic therapy within the past 2 years
  • HIV infection
  • Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA \> 500 IU/mL) or active HCV carriers with detectable HCV RNA;
  • Hypersensitivity to any ingredient of tislelizumab, capecitabine, and oxaliplatin or to any component of the container
  • Other conditions judged by the researcher that do not meet the enrollment requirements

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
  • Shanghai Zhongshan Hospital, Shanghai — Шанхай

Идентификаторы

NCT: NCT07561060 · TNTIT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗