HCCPhase 2HCCNCT04232722
Sorafenib Combined With Arsenical in Treating Patients With Recurrent HCC After Liver Transplantation
A Phase 2 study testing Arsenicals in people with HCC, run by Zhejiang University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC
- What is being tested?
- Arsenicals
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Jun 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.).
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- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
Liang TingBo, MD, PHD, 086-571-87236688, liangtingbo@zju.edu.cn
About this study
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
To analyze the safety, efficacy and pharmacokinetic characteristics of sorafenib combined with compound huangdai tablets in patients with recurrent hepatocellular carcinoma after liver transplantation
Read the 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
- Conditions
- HCC
- Being tested
- Arsenicals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArsenicalsDrug
Also called sorafenib
As4 S4
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Arsenicals |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
objective response rate
Measured: Through the study peirod, for 18 months
Secondary outcomes (4)
PFS
progression-free survival
Measured: Through the study peirod, for 18 months
DCR
disease control rate
Measured: Through the study peirod, for 18 months
OS
overall survival
Measured: Through the study peirod, for 18 months
Safty
adverse event
Measured: Through the study peirod, for 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232722
- Sponsor's protocol ID
- CISLD6
- Acronym
- HCC
- Status last verified
- Jan 2020
- First submitted
- 1 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04232722
- Acronym / sponsor ID
- HCC / CISLD6
- Conditions
- HCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib + arsenical | Experimental | Drug: ArsenicalsAfter 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArsenicalsAlso: sorafenibAs4 S4 | Drug | Sorafenib + arsenical |
Primary outcome
ORR
Time frame: Through the study peirod, for 18 months
objective response rate
4 secondary outcomes
PFS
Time frame: Through the study peirod, for 18 months
DCR
Time frame: Through the study peirod, for 18 months
OS
Time frame: Through the study peirod, for 18 months
Safty
Time frame: Through the study peirod, for 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arsenicals in people with HCC, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hangyu Zhang (0571-87236858, zhanghangyu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: Through the study peirod, for 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.