EUCTR2019-004126-13-DE进行中（未招募）1 期
Cabozantinib treatment in a phase II study for patients with hepatocellular carcinoma (HCC) refractory to PD-1 or PD-L1 inhibitors - CaPture
niversity Leipzig0 个研究点目标入组 40 人开始时间: 2020年6月4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
- 40
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 with diagnosis of locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC)
- •2. Pre-Treatment with a PD-1/PD-L1 inhibitor for at least one administration which was given as first line or as following line systemic treatment alone or in combination with other systemic or local treatments (e.g. TACE)
- •3. Disease progression or end of therapy due to toxicity during/after pre-therapy
- •4. CTCAE = Grade 2 prior to study registration, with the exception of alopecia
- •5. ECOG (Eastern Cooperative of Onco-logy Group) Index 0 or 1
- •6. Age = 18 years
- •7. Written informed consent
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1. Significant portal hypertension (moderate or severe ascites)
- •2. No adequate controlled arterial hypertension (RR > 140/80mmHg)
- •3. ALAT/ASAT five times higher then upper normal value
- •4. Hepatic encephalopathy (every stage)
- •5. Liver cirrhosis Child-Pugh B or C
- •6. Known fibrolamellar HCC, sarcomatoid HCC, or cholangiocarcinoma mixed with HCC
- •7. Major surgical procedure, other than for diagnosis, within eight weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- •8. Severe infection with alteration of general condition within four weeks prior to initiation of study treatment
- •9. Severely impaired kidney function (CKD: stadium 4: GFR<30)
- •10. Myocardial infarction within 12 months prior to initiation of study treatment
- •11. Epilepsy
- •12. Heart failure, Cardiac arrhythmia, respectively long-QT syndrome
- •13. Severe bleeding or high risk for the development of severe bleeding, including esophageal varices > 1° or esophageal varices with red marks as seen on a lighted stomach scope (endoscopy)
- •14. Chronic inflammatory bowel disease (e.g. colitis ulcerosa, diverticulitis, Crohn’s disease)
- •15. Increased risk of thromboembolism due to medical history or disease
- •16. Significant alcohol consumption (>1 drink/day; 1 drink=0.25l beer or 0,1l wine or 2cl spirituous beverages)
- •17. Known active HIV infection
- •18. Known hereditary galactose intolerance, lactase deficiency, glucose-galactose malabsorption
- •19. Prior Cabozantinib use
- •20. Concomitant anticoagulation, at therapeutic doses*
- •21. Predicted life expectancy of less than 6 months
- •22. Female patients who do not meet at least one of the following criteria:
- •Postmenopausal women (Appendix 18.1) (for at least 1 year before the screening visit) OR
- •Postoperative status (6 weeks after bilateral ovariectomy with or without hysterectomy) OR
- •If they are of childbearing potential, agree to practice one highly effective method of contraception and one additional effective (barrier) method at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, OR
- •Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.) OR
- •Abstinence OR
- •Vasectomy of the partner
- •23. Male patients not using one of the following variants for contraception including a period of 4 months after the completion of the therapy:
- •Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. OR
- •Condition after vasectomy OR
- •24. Participation in any other interventional trials within 28 days prior to initiation of study treatment
- •25. Suspected lack of compliance to previous treatments; inability to take the medication
- •26. Pregnancy or lactation, or intention of becoming pregnant during study treatment
- •* Low-dose aspirin for cardioprotection (per local applicable guidelines), low-dose warfarin (= 1 mg/day), and low-dose LMWH are permitted.
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