EUCTR2018-002374-46-FR进行中（未招募）1 期
A randomised phase II trial assessing REGorafenib combined with IRInotecan as second-line treatment in patients with metastatic gastro-oesophageal adenocarcinomas. - REGIRI
ICANCER0 个研究点目标入组 89 人开始时间: 2018年8月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 89
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. Patient must have signed a written informed consent form prior to any study specific procedures
- •2. Patients aged =18 years old
- •3. Histologically confirmed diagnosis of gastro-oesophageal adenocarcinomas: gastroesophageal junction (Siewert II and III) and gastric adenocarcinomas
- •4. Asymptomatic primary tumour
- •5. Metastatic disease
- •6. At least one target lesion (according to RECIST 1.1):
- •Unidimensionally measurable on cross-sectional imaging
- •In an area not previously irradiated
- •7. Disease progression after a fluoropyrimidine and platinum agent-based chemotherapy (5-FU or 5-FU prodrugs combined with cisplatin or oxaliplatin). For example, docetaxel combined with FOLFOX, PD-L1/PD1 inhibitors combined with FOLFOX, LV5-FU2-cisplatin or 5-FU-cisplatin are acceptable prior therapies.
- •8. ECOG performance status =1
- •9. Life expectancy >3 months
- •10. Amylase =1.5 x ULN and lipase =1.5 x ULN
- •11. Adequate liver function:
- •- Total bilirubin =1.5 x ULN
- •- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =3.0 x ULN (=5 x ULN for patients with liver metastasis)
- •- Alkaline phosphatase (ALP) =2.5 x ULN (=5.0 x ULN for patients with liver or bone metastases)
- •12. Platelet count =100,000/mm3; haemoglobin (Hb) =9 g/dL; absolute neutrophil count (ANC) =1,500/mm3. The use of blood transfusion(s) to meet the inclusion criteria will not be allowed
- •13. International normalised ratio (INR) =1.5 x ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) =1.5 x ULN unless receiving treatment with therapeutic anticoagulation. Patients being treated with anticoagulant, e.g., heparin, are eligible if there is no evidence of an underlying abnormality with these parameters and if a close monitoring of at least weekly evaluations was performed until INR and PTT are stable based on a pre-dose measurement as defined by the local standard of care.
- •14. Creatinine clearance (CLcr) =50 mL/min estimated by Cockcroft-Gault equation
- •15. Women of childbearing potential and men must agree to use adequate contraception during the study and for at least 8 weeks after the last study drug administration.
- •16. Patients affiliated to the social security system
- •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 124
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Symptomatic brain metastases or carcinomatous meningitis
- •2. Bone-only metastasis
- •3. Known and documented UGT1A1 deficiency
- •4. History of Gilbert’s syndrome
- •5. Previous or concurrent cancer with a distinct primary site, other than oesogastric cancer, within 5 years prior to randomisation (except for curatively treated cervical cancer in situ, non-melanoma skin cancer, and superficial bladder tumours)
- •6. Persistent proteinuria >3.5 g/24 h measured by urine protein-creatinine ratio from a random urine sample (grade =3, NCI-CTCAE v 5.0)
- •7. Interstitial lung disease with ongoing signs and symptoms at inclusion
- •8. Known hypersensitivity to any of the study drugs, study drug classes, or excipients
- •9. Non-healing wound, non-healing ulcer, or non-healing bone fracture
- •10. Patients with evidence or history of any bleeding diathesis, irrespective of severity
- •11. Any haemorrhage or bleeding event grade =3 (NCI-CTCAE v.5.0) within 4 weeks before starting of the study treatment
- •12. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 month before starting the study treatment (except for adequately treated catheter-related venous thrombosis occurring more than one month before the start of study medication)
- •13. Previous major surgical procedure, significant traumatic injury, or radiotherapy within the 4 weeks before inclusion
- •14. Uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic pressure >90 mmHg) despite optimal medical management. Congestive heart failure: New York Heart Association (NYHA) = class 2
- •15. Unstable angina (angina symptoms at rest), new-onset angina (that started within the last 3 months)
- •16. Myocardial infarction less than 6 months before starting the study treatment
- •17. Uncontrolled cardiac arrhythmias
- •18. History of epileptic seizures requiring long-term anticonvulsant therapy
- •19. History of organ transplantation with use of immunosuppression therapy
- •20. Ongoing bacterial or fungal infection (grade >2 by NCI-CTCAE v.5.0)
- •21. Known history of human immunodeficiency virus (HIV) infection
- •22. Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy
- •23. Use of CYP 3A4 inducers or inhibitors
- •24. Pregnant or breast-feeding women
- •25. Bowel malabsorption or extended bowel resection that could affect the absorption of regorafenib, occlusive syndrome, inability to take oral medications
- •26. Inflammatory bowel disease with chronic diarrhoea
- •27. Participation in another clinical trial within the 30 days before inclusion
- •28. Concurrent treatment with another investigational product or anticancer therapy (other than irinotecan or regorafenib)
- •29. Person kept in detention or incapable of giving consent
- •30. Patient unwilling or unable to comply with the medical follow-up required by the study because of geographic, social, or psychological reasons
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