Preoperative Chemoradiotherapy and Toripalimab in Locally Recurrent Rectal Cancer

Официальное название

Preoperative Treatment with Radiotherapy and Anti-PD1 for Resectable Recurrent Rectal Cancer (TRACER)

Обзор

The study is a prospective, single-center, single-arm, phase II clinical trial. Patients with pelvic recurrent rectal cancer aged from 18 to 75 years, Eastern Cooperative Oncology Group performance status of 0-1, will receive 45-50Gy/25Fx irradiation or 30Gy/15Fx reirradiation (history of pelvic radiation). PD-1 inhibitor (Toripalimab) was used throughout the course of induction chemotherapy (before radiation), concurrent chemoradiation and consolidation chemotherapy (after radiation); radical resection was followed by well-experienced surgeons . The primary endpoint was pathological complete response (pCR) rate. Secondary endpoints were R0 resection rate, 3-year progression-free survival, overall survival, pathological tumor regression grade, operation characteristics and incidence of major surgical complications.

Вмешательства

• Препарат PD-1 antibody (Toripalimab)
  PD-1 antibody: (Toripalimab): 240mg q3w
• Препарат Capecitabine
  Capecitabine:1000mg/m² d1-14 q3w; Capecitabine:825mg/m² on the day of radiotherapy
• Препарат Oxaliplatin
  130 mg/m² q3w
• Препарат Irinotecan
  200 mg/m² q3w
• Лучевая терапия Radiation
  45-50Gy/25Fx or 30Gy/15Fx
• Процедура surgery
  The type of surgery will depend on the site of recurrence and the involvement of adjacent structures, which will be determined by the surgeons.

Первичные конечные точки

• Pathological complete response rate [Срок оценки: up to 1 year]

Вторичные конечные точки (6)

• R0 resection rate [Срок оценки: up to 1 year]
• 3-year Progression-Free Survival [Срок оценки: up to 3 years]
• Overall Survival [Срок оценки: up to 3 years]
• Pathological tumor regression grading [Срок оценки: up to 1 year]
• Operation complications [Срок оценки: up to 1 year]
• Incidence of major surgical complications [Срок оценки: up to 3 months]

Критерии участия

Критерии включения

• Patient is 18-75 years old at the time of signing the informed consent form.
• ECOG performance status 0-1.
• Pathological confirmed or MRI/ enhanced CT confirmed pelvic recurrence.
• No distant metastasis lesions outside the pelvic.
• No prior radiotherapy within 6 months.
• Participants with pelvic recurrence who have not previously been treated with first-line chemotherapy.
• Life expectancy at least 24 weeks.
• Adequate organ function (bone marrow, liver, kidney and clotting function) within 7 days before the first administration without using blood products or hematopoietic stimulating factors.
• Non pregnancy or lactation.
• Fully informed and willing to provide written informed consent for the trial.

Критерии исключения

• Neutrophil < 1.5×10\^9/L, PLT < 75×10\^9/L.
• TBIL > 1.5 ULN.
• AST or ALT > 2.5 ULN, or ALT and / or AST > 5 ULN in patients with liver metastasis.
• Cr > 1.5 ULN.
• Serious electrolyte abnormalities.
• Active coronary artery disease, severe/unstable angina, or newly diagnosed angina or myocardial infarction within 12 months.
• Arterial thrombosis or deep vein thrombosis within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, deep vein thrombosis.
• Congestive cardiac failure ≥ NYHA grade 2.
• Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B defined as HBV-DNA ≥ 500 IU/ml; hepatitis C defined as HCV-RNA higher than lower limit of detection) or hepatitis B and hepatitis C virus co-infection.
• Active inflammatory bowel disease or other colorectal diseases that lead to chronic diarrhea.
• Suspected autoimmune disease.
• Interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (such as diabetes, hypertension, pulmonary fibrosis and acute pneumonia).
• Suspected allergic to any drugs used in the trial.
• History of any immune checkpoint inhibitor therapy.
• Clinically detectable second primary malignancy, or history of other malignancies within 5 years.
• Pregnant or lactating women or women who may be pregnant have a positive pregnancy test before the first medication; Or the female participants themselves and their partners who were unwilling to implement strict contraception during the study period.
• The investigator considers that the subject is not suitable to participate in this clinical study due to any clinical or laboratory abnormalities or compliance problems.
• Serious mental abnormalities.

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

• Sixth Affiliated Hospital, Sun Yat-sen University — Гуанчжоу

Идентификаторы

NCT: NCT06751394 · 2024ZSLYEC-684

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗