2024-517782-16-00招募中2 期
Randomized and multicentre Phase II study of FOLFOX6m + monoclonal Ab (anti-EGFR or bevacizumab) alone or in combination with hepatic chemoembolization (Lifepearls-Irinotecan) in patients with colorectal cancer and metastatic disease limited to the liver with bad prognosis.
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 9
- 主要终点
- Proportion of patients who present an objective radiological response rate at 6 months of treatment. The objective response rate is understood to be the proportion of patients with reduction in tumor size according to RECIST 1.1 criteria.
研究概览
简要总结
To evaluate the radiological objective response rate according to the RECIST version 1.1 criteria at 6 months.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 18 years.
- •Patients with colorectal cancer and exclusive liver metastases with poor prognostic criteria,> 3 lesions and / or size > 5 cm. Patients with the diagnosis of liver metastases with synchronous presentation or with a disease-free interval may be included. If the primary tumor has not been resected, it must be clinically stable. Patients with <3 lesions and/or <5 cm in size may be included if the presentation is synchronous or with a disease-free interval of less than 12 months from the primary tumor surgery. If the primary tumor has not been resected, it must be clinically stable.
- •Measurable disease following RECIST version 1.1 criteria
- •Adequate bone marrow function, according to: a. Hemoglobin ≥ 9.0 g / dl (patients with hemoglobin <9 g / dl can be transfused before inclusion in the study b. Platelet count ≥ 100 x 109 / L c. Absolute neutrophil count (ANC) ≥ 1.5x 109 / L
- •Adequate liver function, based on: a. Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) b. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN . c. alkaline phosphatase ≤ 5xULN d. Adequate renal function, with creatinine <1.5 mg / dL. BUN < 50 mg / dL and blood urea levels < 18 mmol/L. e. Albumin> 3.0 g / dL
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-
- •Patients capable of understanding the information and giving their written informed consent to participate in the study
- •Women and men of childbearing age must commit to abstinence from sexuality or use barrier contraceptive methods during the study and must have a negative pregnancy test.
排除标准
- •Extent of the disease> 50% of the liver parenchyma (assessed by CT performed within the month prior to inclusion)
- •Portal thrombosis
- •Severe Hypertension
- •Extrahepatic metastases
- •Patients with liver metastases measuring less than 5 cm or with a total of 3 or fewer lesions. It should be taken into account that patients with <3 lesions and/or <5 cm in size may be included if the presentation is synchronous or with a disease-free interval of less than 12 months from the primary tumor surgery.
- •Prior chemotherapy treatment for metastatic colorectal cancer
- •Clinically significant cardiovascular diseases: cerebrovascular accident / stroke (≤ 6 months before trial inclusion), myocardial infarction (≤ 6 months prior to trial inclusion), unstable angina, uncontrolled hypertension, NYHA grade II or higher congestive heart failure, or severe cardiac arrhythmia.
- •History of malignancy in the last three years, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix treated appropriately.
- •Altered coagulation (Quick> 50%)
- •Patients with active infectious processes
- •Patients with any of the contraindications specified in the technical data sheet of the drug under study or with allergies to some of the drugs used
- •Pregnant or lactating patients
结局指标
主要结局
Proportion of patients who present an objective radiological response rate at 6 months of treatment. The objective response rate is understood to be the proportion of patients with reduction in tumor size according to RECIST 1.1 criteria.
Proportion of patients who present an objective radiological response rate at 6 months of treatment. The objective response rate is understood to be the proportion of patients with reduction in tumor size according to RECIST 1.1 criteria.
次要结局
- Overall survival time. Overall survival is understood as the time elapsed from the inclusion of the patient in the study to the date of death from any cause.
- Progression-free survival time. PFS is understood as the time elapsed from the inclusion of the patient in the study to the date of radiological progression or death. Patients without radiological documentation of progression will be censored on the date of the last control without evidence of progression.
- Proportion of patients with clinical adverse events, laboratory abnormalities and proportion of patients with discontinuation of treatment due to toxicity or intolerance.
- Hepatic PFS: time from patient inclusion in the study to liver radiological progression according to RECIST 1.1 criteria.
- Proportion of patients undergoing R0 surgery for liver metastases.
研究者
A person designed by the Sponsor
Scientific
Grupo Espanol Multidisciplinar En Cancer Digestivo
研究点 (9)
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