NCT05544812招募中不适用
The First Affilcated Hosipital ,the Air Force Medical University
Xijing Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- AE
研究概览
简要总结
The purpose of this study is to acssess the efficacy and the safety of Sintilimab plus bevacizumab/cetuximab plus XELOX regimen for conversion therapy in patients with advanced colorectal cancer
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Patients had to meet all the following conditions to be enrolled in this study:
- •Pathological diagnosis of colorectal adenocarcinoma; Ambulatory cases, aged 18-75 years; ECOG score less than or equal to 1; Have not received anti-tumor therapy (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunological therapy);
- •Baseline blood routine and biochemical parameters of the subjects met the following criteria:
- •Blood routine examination standards shall meet: A. WBC & GT; 4.0 x 10 / L; b. ANC > 1.5 x 10 / L; C. the ANC acuity 1.5 x 109 / L; D. HB ≥ 80 g/L; E. PLT acuity 100 x 109 / L;
- •Biochemical tests shall meet the following standards:
- •A. TBIL 1.5 x ULN or less; B. ALT and AST & LT; 2.5×ULN, ALT and AST & LT for patients with liver metastases; 5 x ULN; C. BUN and Cr ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 50 mL/min(Cockcroft-Gault formula).
- •No history of other tumors； Be willing and able to follow the protocol during the study； Withdraw from the study at any time during the study without any loss; No history of other tumors; Be willing and able to follow the protocol during the study; Written informed consent was provided prior to study screening and was understood by the patient； Expected life ≥ 6 months
排除标准
- •Patients were not admitted to the study if they met any of the following criteria:
- •Cured basal cell carcinoma of the skin and uterus in patients with other malignancies in the past； Cervical carcinoma in situ is excluded;
- •Patients with known positive HER-2 test;
- •Pregnant or lactating women are in the reproductive period and have not taken effective contraceptive measures, or have fertility requirements during the study period;
- •Serious and uncontrolled medical diseases and infections; Chronic bowel disease or short bowel syndrome;
- •Major organ failure, such as compensatory cardiopulmonary, liver and kidney failure; Severe abnormal liver and kidney function metabolism, affecting the normal drug metabolism;
- •Patients with investigator-identified propensity for gastrointestinal bleeding and/or abnormal coagulation (INR & GT; 1.5);
- •Active HBV or HCV;
- •Patients with peripheral neuropathy NCT-CTCAE ≥ grade 2;
- •Patients who were allergic to the drug in the study protocol were not suitable to participate in the clinical study.
- •Patients with rheumatic diseases, such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, such as ankylosing spondylitis, psoriasis arthritis, gout, pseudogout, etc. Laboratory tests included positive antinuclear antibody, anti-DS-DNA antibody, anti-SM antibody, anti-phospholipid antibody, HLA-B27, rheumatoid factor (RF-igm), anti-cyclic citrulline (CCP) antibody, rheumatoid factor IgG and IgA, antinuclear factor, anti-keratin antibody, etc.
研究组 & 干预措施
experimental
Patients in this group had previously received the following treatment regimens:
Oxaliplatin :130 mg/m2, D1, Q3W; Capecitabine :1000mg/m2, bid q2w Sintilimab for injection :200mg, D1, Q3W Bevacizumab :7.5mg/kg, D1, Q3W or cetuximab :500 mg/m, D1, Q2W
干预措施: Sintilimab ，bevcizumab/cetuximab，XELOX (Drug)
结局指标
主要结局
AE
时间窗: 2-year
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0
次要结局
- ORR(1-year)
- OS(2-year)
- DCR(1-year)
研究者
研究点 (1)
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