PULSAR Combined With PD-1 Ab and Chemotherapy Plus Bev. for CRLM

Официальное название

A Phase II Trial of PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy) Combined With PD-1 Ab and Chemotherapy Plus Bevacizumab for Colorectal Cancer Liver Metastasis

Обзор

To explore Progression-Free-Survival(FPS) of PULSAR(personalized ultrafractionated stereotactic adaptive radiotherapy) combined with PD-1 Ab and Chemotherapy plus Bevacizumabfor CRLM

Вмешательства

• Лучевая терапия Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy
  PULSAR (SBRT): A targeted radiation therapy delivering 5-10 Gy/fraction every 3 weeks (q3w) to the gross tumor volume (GTV), for 3 times.
• Препарат Bevacizumab
  Bevacizumab: 5mg/kg, d1, q3w, 6 cycles.
• Препарат Capecitabine
  Capecitabine: 1000mg/m2, d1-14, bid, q3w, 6 cycles.
• Препарат Oxaliplatin
  Oxaliplatin: 130mg/m2, d1, q3w, 6 cycles.
• Препарат Sintilimab
  Sintilimab: 200mg, d1, q3w, 6 cycles.

Первичные конечные точки

• Progression-free-Survival [Срок оценки: From enrollment to 36 month]

Вторичные конечные точки (3)

• Adverse Reactions [Срок оценки: From enrollment to 36 month]
• Overall Survival (OS) [Срок оценки: From enrollment to 36 month]
• Objective Response Rate (ORR) [Срок оценки: From enrollment to 36 month]

Критерии участия

Критерии включения

• Age 18-75 years, any gender.
• Pathologically confirmed colorectal cancer with liver metastases (stage M1).
• Karnofsky Performance Status ≥70.
• Adequate organ function, no contraindications to 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

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fujian Cancer Hospital — Фучжоу

Идентификаторы

NCT: NCT06788171 · LIVERT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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