Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)

Обзор

This is a single arm phase II study to explore the 3y LRFS and safety for high-risk early rectal cancer after local excision with short-course radiotherapy and chemo-immunotherapy.

Подробное описание

A total of 60 patients with high-risk pathologic stage pT1 or pT2 cancer after local excision but refused radical surgery will be included.

Eligibility criteria include a histological diagnosis of adenocarcinoma located ≤7 cm from the anal verge, pT1 after local excision of the primary rectal cancer, with one of the high-risk features including margin positivity/very close margin (\<1mm) at time of local excision, depth of invasion \>1 mm or SM3 invasion (submucosal invasion to the lower third of the submucosal level), high grade or poorly differentiated, lymphovascular invasion, perineural invasion, tumour budding, or pT2 tumor.

They will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody.

Вмешательства

• Лучевая терапия Radiation
  Shor-course radiotherapy: 25Gy/5Fx
• Препарат PD-1 antibody
  PD-1 antibody (Toripalimab): 240mg d1 q3w
• Препарат Capecitabine
  Capecitabine: 1000mg/m2 d1-14 q3w
• Препарат Oxaliplatin
  Oxaliplatin: 130mg/m2 d1 q3w

Первичные конечные точки

• 3y LRFS [Срок оценки: From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.]

Вторичные конечные точки (3)

• 3y DFS [Срок оценки: From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.]
• 3y OS [Срок оценки: From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.]
• Grade 3-4 adverse effects rate [Срок оценки: From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.]

Критерии участия

Критерии включения

• age 18-75 years old, female and male
• pathological confirmed adenocarcinoma
• the distance from anal verge ≤ 7 cm
• pT1 after local excision of the primary rectal cancer, with at least one of the high-risk features including margin positivity/very close margin (<1mm) at time of local excision, depth of invasion >1 mm or SM3 invasion (submucosal invasion to the lower third of the submucosal level), high grade or poorly differentiated, lymphovascular invasion, perineural invasion, tumour budding, or pT2 tumor.
• refuse radical surgery
• without pelvic or distance metastases
• KPS >=70
• with good compliance
• microsatellite repair status is MSS/pMMR
• without previous anti-cancer therapy or immunotherapy
• signed the inform consent

Критерии исключения

• pregnancy or breast-feeding women
• pathological confirmed signet ring cell carcinoma
• history of other malignancies within 5 years
• serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
• immunodeficiency disease or long-term using of immunosuppressive agents
• baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
• DPD deficiency
• allergic to any component of the 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

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT06455124 · FDRT-2024-31-3584

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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