EUCTR2019-004196-39-FR进行中（未招募）1 期
A randomized, phase II study comparing the sequences of regorafenib and trifluridine/tipiracil, after failure of standard therapies in patients with metastatic colorectal cancer - SOREGATT
ICANCER0 个研究点目标入组 340 人开始时间: 2020年6月8日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 340
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patients must have provided informed consent before performing any study specific procedures.
- •2.Histological or cytological documented adenocarcinoma of the colon or rectum.
- •3.Patients with metastatic colorectal cancer (stage IV).
- •4.Measurable disease, defined as at least one unidimensional measurable lesion on a computed tomography (CT) scan according to RECIST v1.1
- •5.The patient must have received two or more previous lines of treatment for metastatic disease. The prior treatment lines must include at least one fluoropyrimidine-based chemotherapy combined with oxaliplatin and/or irinotecan (including FOLFOX, FOLFIRI or FOLFOXIRI) as well as EGFR and/or VEGF inhibitors in patients eligible for these treatments.
- •6.Patients considered eligible for treatment with both regorafenib and trifluridine-tipiracil.
- •7.Male or female patients aged =18 years.
- •8.ECOG performance status of =1.
- •9.Adequate bone marrow, liver and renal functions as assessed by the following laboratory requirements:
- •Total bilirubin =1.5 x upper limit of normal (ULN).
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 x ULN (=5 x ULN for patients with liver metastasis).
- •Alkaline phosphatase limit =2.5 x ULN (=5 x ULN for patients with liver metastasis).
- •Serum creatinine =1.5 x ULN.
- •International normalized ratio (INR) and partial thromboplastin time (PTT) =1.5 x ULN. Patients receiving anticoagulants, such as warfarin or heparin are eligible if there is no prior evidence of an underlying abnormality with coagulation.
- •Platelet count =100000 /mm3, hemoglobin (Hb) =9 g/dL, absolute neutrophil count (ANC) =1500/mm3. Blood transfusions to meet this inclusion criterion are not allowed.
- •10.Women of childbearing potential and men must agree to use a highly effective contraception (<1% failure rate) from the signing of the informed consent form until at least 6 months after the last study drug administration. Women using hormonal contraceptive must also use a barrier method.
- •11.Women of childbearing potential must have a negative pregnancy test within 7 days before starting study treatment.
- •12.Patients affiliated to the social security system
- •13.Patient willing and able to comply with the protocol for the duration of the study including treatment, scheduled visits, and examinations throughout the study, including follow up.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •1.Patients with symptomatic brain or meningeal metastasis, unless definitive therapy occurred more than 6 months ago and with a confirmation of tumoral control within 4 weeks of starting study treatment.
- •2.Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to study inclusion, except for curatively treated in situ cervical cancer, non-melanoma skin cancer, and superficial bladder tumors: staged Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor with lamina propria invasion).
- •3.Prior treatment with regorafenib or any other tyrosine kinase inhibitor.
- •4.Prior treatment with trifluridine/tipiracil.
- •5.Known hypersensitivity to any of the study drugs, study drug classes, or study drug excipients.
- •6.Unresolved toxicity grade >1 (by CTCAE v5.0) caused by prior therapy/procedure, excluding alopecia, hypothyroidism, and oxaliplatin-induced neurotoxicity grade =2.
- •7.Patient with severe hepatic impairment (Child-Pugh C).
- •8.Known UGT1A1 and/or UGT1A9 polymorphisms. History of Gilbert's syndrome.
- •9.Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before starting study treatment.
- •10.Chemotherapy within 21 days of starting study treatment.
- •11.Radiotherapy within 4 weeks of starting study treatment, except for palliative radiotherapy within 2 weeks.
- •12.Active cardiac disease including any of the following:
- •Congestive heart failure: New York Heart Association (NYHA) class =2.
- •Unstable angina (angina symptoms at rest), or a new-onset angina (within the 3 months before enrolment).
- •Myocardial infarction that occurred less than 6 months before enrolment.
- •Cardiac arrhythmias requiring anti-arrhythmic therapy (treatment with beta blockers or digoxin are permitted)
- •Uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic pressure >90 mmHg despite treatment).
- •13.Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 6 months of starting study treatment.
- •14.Ongoing infection grade >2 (CTCAE v5.0).
- •15.Known history of human immunodeficiency virus (HIV) infection.
- •16.Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy.
- •17.Patients with seizure disorder requiring medication.
- •18.Patients with a history of any bleeding diathesis, irrespective of the severity.
- •19.Any hemorrhage or bleeding event grade =3 (CTCAE v5.0) within the 4 weeks before starting study treatment.
- •20.Presence of a wound, ulcer, or bone fracture that is not healing.
- •21.Patients unable to swallow oral medications.
- •22.Bowel malabsorption or extended bowel resection that could affect the absorption of regorafenib, occlusive syndrome,
- •23.Presence of gastro-intestinal fistula or perforation
- •24.Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and their compliance in the study.
- •25.Patients participating in another therapeutic study within the 30 days before enrolment.
- •26.Pregnant or breast feeding women.
- •27.Person deprived of their liberty or under protective custody or guardianship.
研究者
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