NCT06788171尚未招募2 期
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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Progression-free-Survival
研究概览
简要总结
To explore Progression-Free-Survival(FPS) of PULSAR(personalized ultrafractionated stereotactic adaptive radiotherapy) combined with PD-1 Ab and Chemotherapy plus Bevacizumabfor CRLM
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years, any gender.
- •Pathologically confirmed colorectal cancer with liver metastases (stage M1).
- •Karnofsky Performance Status ≥
- •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.
排除标准
- •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.
研究组 & 干预措施
PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy
Experimental
Interventions:
- Radiation: PULSAR(Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy)
- Drug: Bevacizumab
- Drug: Capecitabine
- Drug: Oxaliplatin
- Drug: Sintilimab
干预措施: Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (Radiation)
PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy
Experimental
Interventions:
- Radiation: PULSAR(Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy)
- Drug: Bevacizumab
- Drug: Capecitabine
- Drug: Oxaliplatin
- Drug: Sintilimab
干预措施: Bevacizumab (Drug)
PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy
Experimental
Interventions:
- Radiation: PULSAR(Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy)
- Drug: Bevacizumab
- Drug: Capecitabine
- Drug: Oxaliplatin
- Drug: Sintilimab
干预措施: Capecitabine (Drug)
PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy
Experimental
Interventions:
- Radiation: PULSAR(Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy)
- Drug: Bevacizumab
- Drug: Capecitabine
- Drug: Oxaliplatin
- Drug: Sintilimab
干预措施: Oxaliplatin (Drug)
PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy
Experimental
Interventions:
- Radiation: PULSAR(Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy)
- Drug: Bevacizumab
- Drug: Capecitabine
- Drug: Oxaliplatin
- Drug: Sintilimab
干预措施: Sintilimab (Drug)
结局指标
主要结局
Progression-free-Survival
时间窗: From enrollment to 36 month
次要结局
- Adverse Reactions(From enrollment to 36 month)
- Overall Survival (OS)(From enrollment to 36 month)
- Objective Response Rate (ORR)(From enrollment to 36 month)
研究者
研究点 (1)
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