NL-OMON56792尚未招募2 期
Single-arm, phase II trial of trifluridine/tipiracil (FTD-TPI), bevacizumab, and individualized radioembolization with 166Ho-microspheres in refractory metastatic colorectal cancer. - STARLIGHT
niversitair Medisch Centrum Utrecht0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Unresectable liver dominant mCRC
- •Prior therapy with fluoropyrimidine, oxaliplatin, and irinotecan for the
- •treatment of advanced colorectal cancer and had demonstrated progressive
- •disease or intolerance to their last regimen
- •Written informed consent
- •Age >=18 years
- •Estimated hepatic tumor replacement >= 10% and <= 50% of total liver volume
- •ECOG performance status 0-1
- •Adequate organ function as measured by:
- •o WBC >= 3.0 x 109/L, platelets >= 100 x 109/L, absolute neutrophil count > 1.5 x
- •109/L, Hemoglobin > 5 mmol/L (>8.1 g/dL)
- •o eGFR >= 35 ml/min
- •o Serum transaminases (AST & ALT) <= 5 x ULN
- •o Total bilirubin <= ULN
- •o Albumin > 3 g/dL
- •At least one measurable liver lesion according to the PERCIST 1.0
- •Included in PLCRC
排除标准
- •Significant extrahepatic disease, defined as symptomatic extrahepatic
- •disease, greater than 10 pulmonary nodules (maximum diameter of each lung
- •metastasis <20mm), and/or peritoneal carcinomatosis. (Definition of liver
- •dominant disease)(Fidelman et al., 2022)
- •Eligible for local treatment of liver metastases (e.g. surgical resection,
- •Lung shunt >20 Gy, as calculated using scout dose SPECT/CT
- •Absorbed tumor dose <90 Gy when dosing at a maximum average absorbed normal
- •Other malignancy confounding prognosis
- •Receipt of chemotherapy within 28*days prior to study treatment
- •Previous or current treatment with radioembolization
- •Major surgery within 28 days or incompletely healed surgical incision before
- •starting study therapy
- •Any serious comorbidity preventing the safe administration of anti-VEGF
- •antibody treatment. This includes uncontrolled hypertension or treatment with
- •>=3 antihypertensive drugs, arterial (cerebro)vascular event within the past 6
- •months, history of severe bleeding, history of GI perforation, or presence of
- •Any serious and/or chronic liver disease preventing the safe administration
- •of radioembolization
- •Uncorrectable extrahepatic deposition of scout dose activity; activity in the
- •falciform ligament, portal lymph nodes and gallbladder is accepted
- •Pregnancy or breastfeeding
- •Body weight over 150 kg (because of maximum table load)
- •Known severe allergy for intravenous contrast fluids
- •Participation to another investigational study which may compromise any
- •endpoint of the study
研究者
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