Long-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC)

Официальное название

A Prospective Randomized Phase II Trial of Long-Course Chemoradiotherapy or Short-Course Radiotherapy Combined With CAPOX, PD-1 Antibody, and a COX-2 Inhibitor for Microsatellite Stable Locally Advanced Rectal Cancer (SERRAC)

Обзор

SERRAC is a prospective, multicentre, randomized phase II trial. 138 LARC (T3-4/N+M0, distance from anal verge ≤10cm) patients will be treated with neoadjuvant therapy and assigned to Group A and Group B (1:1). Group 1 receives LCRT (50Gy/25Fx) followed by 3 cycles of CAPOX.Group 2 receives SCRT (25Gy/5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. The COX2 inhibitor celecoxib 200 mg was started orally twice a day during chemotherapy until the end of neoadjuvant treatment.TME surgery is scheduled after TNT while a watch and wait (W\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.

Вмешательства

• Лучевая терапия Long-course radiotherapy
  Long-course radiation: 50Gy/25Fx
• Препарат Oxaliplatin
  Oxaliplatin: 130mg/m2 d1 q3w
• Препарат Capecitabine
  Xeloda
• Препарат Celecoxib
  celecoxib 200 mg orally twice a day
• Лучевая терапия Short-course radiotherapy
  Short-course radiotherapy: 25Gy/5Fx
• Препарат Serplulimab
  Serplulimab 300mg, d1, q3w

Первичные конечные точки

• Complete response (CR) rate [Срок оценки: 1 month after the surgery or the decision of W&W]

Вторичные конечные точки (6)

• Grade 3-4 adverse effects rate [Срок оценки: From date of randomization until 3 months after the completion neoadjuvant therapy]
• 3 year anal preservation rate [Срок оценки: From date of randomization until the date of or date of death from any cause, whichever came first, assessed up to 36 months.]
• 3 year disease free survival rate [Срок оценки: From 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 local recurrence free survival rate [Срок оценки: From date of randomization until the date of first documented pelvic failure, assessed up to 36 months.]
• 3 year overall survival rate [Срок оценки: From date of randomization until the date of death from any cause, assessed up to 36 months.]
• Rate of surgical complications [Срок оценки: The surgical complications were assessed within 3 months after the surgery.]

Критерии участия

Критерии включения

• Age 18-75 years, gender not limited
• Pathologically confirmed rectal adenocarcinoma
• ≤10 cm from the anus
• Baseline stage T3-4/N+
• No distant metastasis
• MSI/MMR status MSS/pMMR
• Karnofsky performance status score ≥70
• No prior chemotherapy or other anti-cancer treatment prior to enrollment
• No prior immunotherapy prior to enrollment
• Ability to comply with the study protocol
• Written informed consent

Критерии исключения

• Pregnancy or breast-feeding women;
• Known history of other malignancies within 5 years;
• Known history of previous anti-tumor treatment, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T cell-related therapy, etc;
• Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);
• Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;
• Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;
• Uncontrolled infection which needs systemic therapy;
• Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents;
• Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection
• 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

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT07150949 · FDRT-2025-254-4403

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗