MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer

Официальное название

A Prospective, Randomized, Phase II Trial of MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer

Обзор

NeoPulsar is a prospective, randomized phase II trial. 46 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with MR-guided adaptive radiotherapy (30Gy/6Fx) combined with 6 cycles of Toripalimab and CAPOX. TME surgery is scheduled after TNT. The primary endpoint is pathological complete response (pCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal function, surgical complication, 3-year LRFS rate, 3-year DFS rate, 3-year OS rate, etc.

Вмешательства

• Препарат PD-1 antibody
  PD-1 antibody (Toripalimab): 240mg d1 q3w
• Препарат Oxaliplatin
  Oxaliplatin: 130mg/m2 d1 q3w
• Препарат Capecitabine
  Capecitabine: 1000mg/m2 bid d1-14 q3w

Первичные конечные точки

• Pathological complete response (pCR) rate [Срок оценки: 1 month after the surgery]

Вторичные конечные точки (6)

• Grade 3-4 adverse effects rate [Срок оценки: From the date of randomization until 3 months after the completion neoadjuvant therapy]
• Anal function [Срок оценки: From the date of randomization until 36 months after the surgery]
• Surgical complication [Срок оценки: The surgical complications were assessed within 3 months after the surgery]
• 3-year local recurrence free survival (LRFS) rate [Срок оценки: From the date of randomization until the date of first documented pelvic failure, assessed up to 36 months]
• 3-year disease free survival (DFS) rate [Срок оценки: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months]
• 3-year overall survival (OS) rate [Срок оценки: From the date of randomization until the date of death from any cause, assessed up to 36 months]

Критерии участия

Критерии включения

• Age 18-70 years old, male or female
• Pathologically confirmed rectal adenocarcinoma
• The distance from anal verge ≤ 10 cm
• Clinical stage T3-4 and/or N+
• No evidence of distance metastases
• MSI/MMR status: MSS/pMMR
• Karnofsky score >=70
• Adequate organ function and have no contraindications to surgery, radiochemotherapy, or immunotherapy
• No chemotherapy or any other anti-tumor therapy prior to enrollment
• No immunotherapy prior to enrollment
• With good compliance during the study
• Signed written informed consent

Критерии исключения

• Known history of other malignancies within 5 years， except cured skin cancer and cervical cancer in situ
• Pregnancy or breast-feeding women
• Individuals with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders that, in the judgment of the investigator, are of such clinical severity that they may prevent the signing of an informed consent form or affect the patient's adherence to oral medications
• Individuals with clinically serious (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months
• Individuals with a history of organ transplantation requiring immunosuppressive therapy and long-term hormone therapy
• Individuals with autoimmune diseases
• Individuals with severe uncontrolled recurrent infections，or other severe uncontrolled concomitant diseases
• Baseline hematology and biochemistry not meeting the following criteria: Hb≥90g/L; NEU ≥1.5×109/L; PLT ≥100×109/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; TB <1.5 times the upper limit of normal; Cr <1 time the upper limit of normal; Alb ≥30g/L
• Individuals with dihydropyrimidine dehydrogenase (DPD) deficiency
• Individuals allergic to any drug component of the study

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

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT06840665 · FDRT-2024-293-3847

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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