Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer

Официальное название

Prospective, Randomized, Phase II Trial of Modified Short-Course Radiotherapy Plus CAPOX and Tislelizumab Versus Long-Course Chemoradiotherapy Plus Tislelizumab for Locally Advanced Rectal Cancer

Обзор

To explore the complete response (CR) rate of modified short-course radiotherapy plus CAPOX and Tislelizumab versus Long-course Chemoradiotherapy plus Tislelizumab for locally advanced rectal cancer.

Подробное описание

In the exploration of treatments for locally advanced rectal cancer (LARC), the novel model combining short-course radiotherapy with CAPOX chemotherapy and PD-1 inhibitor (tislelizumab) is demonstrating promising potential. By comparing the efficacy and safety of modified short-course radiotherapy versus traditional long-course radiotherapy within this combination regimen, this study aims to identify the optimal radiotherapy strategy to maximize tumor regression and improve the complete response rate, thereby offering a more promising treatment option for rectal cancer patients seeking organ preservation.

Вмешательства

• Лучевая терапия Modified Short-course radiotherapy
  Rectal lesion + metastatic lymph nodes, GTV 30Gy/5Fx. Pelvic lymphatic drainage area, CTV 22.5Gy/5Fx.
• Лучевая терапия Long-course radiotherapy
  Rectal lesion + metastatic lymph nodes+pelvic lymphatic drainage area,50.4 Gy/25 f
• Препарат Oxaliplatin
  130 mg/m²,d1, q3w ,4 cycles
• Препарат Capecitabine
  1000 mg/m, d1-14,bid,q3w, 4 cycles
• Препарат Tislelizumab
  200mg,d1,q3w,4 cycles
• Препарат Capecitabine
  825 mg/m² ,BID ,on radiation days
• Препарат Tislelizumab
  200mg,d1,q3w,3 cycles

Первичные конечные точки

• Complete Response (CR) Rate [Срок оценки: t 3 months after completion of neoadjuvant therapy and up to 12 months after enrollment.]

Вторичные конечные точки (7)

• Organ Preservation Rate [Срок оценки: 1 year.]
• Surgical Complications [Срок оценки: Within 30 days post-surgery]
• the Quality of Life [Срок оценки: Baseline, before surgery, and up to 12 months after surgery]
• Grade ≥3 Adverse Event Rate [Срок оценки: From start of treatment to 30 days after last dose, up to approximately 6 months]
• 3y-DFS [Срок оценки: From enrollment to 36 month]
• 3y-LRFS [Срок оценки: From enrollment to 36 month]
• 3y-OS [Срок оценки: From enrollment to 36 month]

Критерии участия

Критерии включения

• Age 18-75 years, any gender.
• Pathologically confirmed rectal adenocarcinoma.
• Baseline MR stage T3-4/N+.
• Distance from anal verge ≤12cm.
• No distant metastasis.
• Karnofsky Performance Status ≥70.
• Adequate organ function, no contraindications to surgery, radiotherapy, or immunotherapy.
• Microsatellite/mismatch repair status MSS/pMMR.
• No prior chemotherapy or any other anti-tumor treatment before inclusion.
• No prior immunotherapy.
• Ability to comply with the study protocol during the study period.
• Signed written informed consent.

Критерии исключения

• Pregnant or lactating women.
• Pathological diagnosis of signet ring cell carcinoma.
• History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ.
• Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication.
• Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months.
• Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users.
• Patients with autoimmune diseases.
• Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities.
• Subjects with baseline hematological and biochemical parameters not meeting the following criteria: hemoglobin ≥90g/L; absolute neutrophil count (ANC) .≥1.5×10\^9/L; platelets ≥100×10\^9/L; ALT, AST ≤2.5 times the upper limit of normal; ALP

≤2.5 times the upper limit of normal; serum total bilirubin <1.5 times the upper limit of normal; serum creatinine <1 times the upper limit of normal; serum albumin ≥30g/L.

• Known deficiency of dihydropyrimidine dehydrogenase (DPD).
• Allergy to any investigational drug components.

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 · 3 центра

• Fujian Cancer Hospital — Фучжоу
• The Second Hospital of Longyan — Longyan
• Jinjiang Municipal Hospital — Quanzhou

Идентификаторы

NCT: NCT07469306 · CATIMOR-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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