- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04232722
Sorafenib Combined With Arsenical in Treating Patients With Recurrent HCC After Liver Transplantation (HCC)
January 14, 2020 updated by: TingBo Liang, Zhejiang University
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
To analyze the safety, efficacy and pharmacokinetic characteristics of sorafenib combined with compound huangdai tablets in patients with recurrent hepatocellular carcinoma after liver transplantation
Study Overview
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
Study Type
Interventional
Enrollment (Anticipated)
43
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hangyu Zhang
- Phone Number: 0571-87236858
- Email: zhanghangyu@zju.edu.cn
Study Locations
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-
Zhejiang
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Hangzhou, Zhejiang, China, 310003
- Recruiting
- the First Affiliated Hospital, School of Medicine, Zhejiang University
-
Contact:
- Liang TingBo, MD, PHD
- Phone Number: 086-571-87236688
- Email: liangtingbo@zju.edu.cn
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sorafenib + arsenical
After enrollment, the patients received oral treatment at sorafenib 200mg bid continuous and realgar-indigo naturalis formula preparation at 60mg/kg tid p.o, d1-14, q4w
|
As4 S4
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR
Time Frame: Through the study peirod, for 18 months
|
objective response rate
|
Through the study peirod, for 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS
Time Frame: Through the study peirod, for 18 months
|
progression-free survival
|
Through the study peirod, for 18 months
|
DCR
Time Frame: Through the study peirod, for 18 months
|
disease control rate
|
Through the study peirod, for 18 months
|
OS
Time Frame: Through the study peirod, for 18 months
|
overall survival
|
Through the study peirod, for 18 months
|
Safty
Time Frame: Through the study peirod, for 18 months
|
adverse event
|
Through the study peirod, for 18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Anticipated)
December 31, 2021
Study Completion (Anticipated)
June 30, 2022
Study Registration Dates
First Submitted
January 1, 2020
First Submitted That Met QC Criteria
January 14, 2020
First Posted (Actual)
January 18, 2020
Study Record Updates
Last Update Posted (Actual)
January 18, 2020
Last Update Submitted That Met QC Criteria
January 14, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CISLD6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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