Clinical trial NCT04232722: Sorafenib Combined With Arsenical in Treating Patients With Recurrent HCC After Liver Transplantation
Official title: An Exploratory Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Sorafenib Combined With Realgar-Indigo Naturalis Formula (RIF) in in Treating Patients With Recurrent Hepatocellular Carcinoma After Liver Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HCC
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To analyze the safety, efficacy and pharmacokinetic characteristics of sorafenib combined with compound huangdai tablets in patients with recurrent hepatocellular carcinoma after liver transplantation

Detailed description: Background: postoperative recurrence after liver transplantation is a global problem, and there is no standard treatment model for postoperative recurrence. Objective: to select patients diagnosed with hepatocellular carcinoma (HCC) after liver transplantation and unable to receive local treatment, and to give sorafenib combined with realgar-indigo naturalis formula until the disease progression or the patient die or is lost to follow-up. To analyze the safety, efficacy and pharmacokinetic characteristics of sorafenib combined with compound huangdai tablets in patients with recurrent hepatocellular carcinoma after liver transplantation

Eligibility criteria: Inclusion Criteria:

* aged 18-75 (inclusive), male or female;
* recurrence of HCC after liver transplantation;
* grade C according to the Barcelona liver cancer classification criteria (BCLC) or grade B not suitable for local treatment/progression of local treatment
* according to RECIST1.1, there was at least one target lesion that could be stably evaluated, defined as: longest diameter of non-lymph node lesion ≥10mm, or shortest diameter of lymph node lesion ≥15mm; The intrahepatic lesions required enhanced arterial development
* expected survival more than 12 weeks;
* child-pugh score ≤7;
* ECOG score 0-1;
* if the subject is HBsAg positive or HBcAb positive, hbv-dna \< 200 IU/ml should be satisfied. HBsAg positive subjects must receive antiviral therapy in accordance with the 2015 guidelines for the prevention and treatment of chronic hepatitis B.
* subject should meet the following test results before screening and pretreatment (at baseline). If abnormal laboratory tests do not meet the following criteria, the subjects are allowed to re-examine within one week. If they still do not meet the criteria, the screening will be considered a failure: A. Blood routine (no blood transfusion, platelet transfusion, cell growth factor (except recombinant erythropoietin) and other supportive treatments should be performed within 7 days before the test) : WBC ≥ 2.5×109/L; Platelet count (PLT) ≥60×109/L; Hemoglobin (Hb) ≥ 9.0g /dL; B. Blood biochemistry: serum albumin (Alb) ≥30 g/L; The clearance rate of endogenous creatinine was ≥50 mL/min (Cockcroft -Gault formula was used). Alanine aminotransferase (ALT) ≤5× upper limit of normal value (ULN); Aspartate aminotransferase (AST) ≤5×ULN; Alkaline phosphatase ≤5×ULN; Total bilirubin ≤2×ULN; C. Prothrombin time (PT) : prothrombin time extension ≤ 4 s;
* women of child-bearing age must undergo a serum pregnancy test within the screening period and 14 days prior to the initiation of the study drug, with negative results, and be willing to use reliable methods of contraception during the test period; Male subjects whose partners are women of child-bearing age should be sterilized or agree to use reliable methods of contraception during the trial;
* be able to understand and sign the informed consent.

Exclusion Criteria:

* participate in other clinical trials or use other research drugs or devices within 4 weeks of the first treatment.
* pregnant or breastfeeding women;
* positive for human immunodeficiency virus (HIV) antibody, treponema pallidum antibody or hepatitis C virus (HCV-RNA) antibody;
* any uncontrolled active infection, including but not limited to subjects with active tuberculosis;
* previous or present hepatic encephalopathy;
* the presence of clinically significant ascites is defined as the ascites that are positive on physical examination or that need to be controlled by intervention therapy (for example, puncture or drug therapy, etc.).
* imaging results: the proportion of liver replaced by tumor was ≥50%, and the main portal vein tumor thrombus or tumor thrombus invaded mesenteric vein/inferior vena cava;
* adverse reactions caused by previous treatment did not return to the standard term for adverse events (CTCAE) ≤1, except hair loss and other tolerable events judged by researchers;
* subjects who currently have unstable or active ulcers, gastrointestinal bleeding, or intolerance to proton pump inhibitors;

Primary outcomes:
measure: ORR
timeFrame: Through the study peirod, for 18 months
Secondary outcomes:
measure: PFS
timeFrame: Through the study peirod, for 18 months
measure: DCR
timeFrame: Through the study peirod, for 18 months
measure: OS
timeFrame: Through the study peirod, for 18 months
measure: Safty
timeFrame: Through the study peirod, for 18 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the First Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: