A national prospective study of patients with hepatitis induced by immune checkpoint inhibitors; Characterization of liver injury, outcome of therapy and randomization to either mycophenolate mofetil or tacrolimus treatment in case of steroid resistance - I-HEP

ational Center for Cancer Immune Therapy (CCIT-DK)0 个研究点目标入组 80 人开始时间: 2020年9月17日最近更新: 2021年3月30日

适应症

试验速览

暂无简介。

•4.3.1Inclusion criteria
•-Histologically confirmed solid cancer
•-Treatment with CTLA-4 or PD-1/PD-L1 inhibitor or a combination of CTLA-4 plus PD-1 inhibitors within 6 months
•-Abnormal liver parameters equal to = grade 3 ir-hepatitis defined as; AST/ALT >5 x ULN, INR = 2.5 x ULN, or bilirubin > 3.0 x ULN
•-= 18 years of age
•-Women of childbearing potential: Negative serum pregnancy test and must use effective contraception. This applies from screening and until 6 months after treatment. Birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot patch are all considered effective contraceptives
•-Men with female partner of childbearing potential must use effective contraception from screening and until 6 months after treatment. Effective contraceptives are as described above for the female partner. In addition, documented vasectomy and sterility or double barrier contraception are considered effective contraceptives
•-Signed statement of consent after receiving oral and written study information
•-Willingness to participate in the planned treatment and follow-up and capable of handling toxicities.
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•4.3.2Exclusion criteria
•-Concomitant chemotherapy treatment or tyrosine kinases or angiogenesis inhibitors
•-Concomitant immunosuppressive medication except prednisolone
•- Patients with hepatocellular carcinoma
•-Known hypersensitivity to one of the active drugs or excipients
•-Uncontrolled infection
•-Acute viral hepatitis
•-Any medical condition that will interfere with patient compliance or safety
•-Simultaneous treatment with other experimental drugs or other anti-cancer drugs
•-Pregnant or breastfeeding females
•-Phenylketonuria

发起方

ational Center for Cancer Immune Therapy (CCIT-DK)