2024-518987-11-00招募中2 期
CETUXIMAB, IRINOTECAN AND FLUOROURACILE IN FIRST-LINE TREATMENT OF IMMUNOLOGICALLY-SELECTED ADVANCED COLORECTAL CANCER PATIENTS - the CIFRA study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Activity assessed by RECIST criteria version 1.1
研究概览
简要总结
To evaluate whether the administration of FOLFIRI/Cetuximab is effective as a first-line treatment for patients with metastatic colorectal cancer, RAS wild-type and FcγRIIIA V/V.
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
- 是
入选标准
- •Cytological or histological diagnosis of colorectal adenocarcinoma FOLFIRI+Cetuximab in first-line treatment of metastatic colorectal cancer, RAS wild type, and Fc-γRIIIA-V/V
- •Written informed consent
- •RAS wild-type
- •FcγRIIIa-158V/V genotype
- •Negative pregnancy test, where applicable
- •Age < 75 years
- •At least one measurable lesion according to RECIST v1.1 criteria
- •ECOG Performance Status 0 or 1
- •Life expectancy > 3 months
排除标准
- •Previous systemic anti-tumor treatment; treatment with Capecitabine or fluorouracil and radiotherapy is allowed in the neoadjuvant setting for rectal cancer, provided that therapy was completed at least 6 months prior.
- •Refusal or inability to provide informed consent
- •Inability to ensure follow-up
- •Presence of untreated stenosing primary colorectal neoplasia with the placement of an endoprosthesis
- •Neutrophils < 2000/mm³, or platelets < 100,000/mm³, or hemoglobin < 9 g/dl
- •Creatinine > 1.5 times the upper normal limit
- •GOT (AST) and/or GPT (ALT) > 5 times the upper normal limit and/or bilirubin > 3 times the upper normal limit
- •Previous malignant neoplasia (excluding basal cell or squamous cell skin carcinoma or in situ carcinoma of the uterine cervix)
- •Active or uncontrolled infection
- •Other concomitant decompensated or uncontrolled diseases, or conditions that contraindicate the study drugs, at the clinician's discretion
- •Presence of brain metastases
结局指标
主要结局
Activity assessed by RECIST criteria version 1.1
Activity assessed by RECIST criteria version 1.1
次要结局
- Response duration
- PFS will be determined from the date of treatment start until progression.
- OS will be measured from treatment start until death from any cause.
- Toxic effects assessed by CTCAE of the National Cancer Institute, version 4.0, June 14, 2010
研究者
Alessandro Ottaiano
Scientific
IRCCS Istituto Nazionale Tumori Fondazione Pascale
研究点 (4)
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