Sorafenib Combined With Arsenical in Treating Patients With Recurrent HCC After Liver Transplantation

NCT04232722 | Unknown Phase 2

• 1 other identifier: CISLD6
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

Conditions

HCC

Outcome Measures

Primary Outcomes (1)

• ORR

  objective response rate

  Through the study peirod, for 18 months

Secondary Outcomes (4)

• PFS

  Through the study peirod, for 18 months

• DCR

  Through the study peirod, for 18 months

• OS

  Through the study peirod, for 18 months

• Safty

  Through the study peirod, for 18 months

Study Arms (1)

Sorafenib + arsenical

EXPERIMENTAL

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

Drug: Arsenicals

Interventions

Arsenicals DRUG

As4 S4

Also known as: sorafenib

Sorafenib + arsenical

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Interventions

Arsenicals; Sorafenib

Intervention Hierarchy (Ancestors)

Inorganic Chemicals; Organic Chemicals; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Hangyu Zhang

CONTACT

0571-87236858; zhanghangyu@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 1, 2020
• First Posted: January 18, 2020
• Study Start: January 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)