Hepatocellular Carcinoma Non-resectableNCT03881501
Evaluate the Treatment With Sintilimab Injection Plus Endostar in Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma Non-resectable, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
It is a a single arm, observational clinical trial to evaluate the efficacy and safety of combination treatment with sintilimab injection plus endostar in untreated locally advanced or metastatic hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma Non-resectable
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2019to Mar 2020
- Phase
- Observational
- 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
Study population: Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
Who may be able to join
- Able and willing to comply with the study plans in this protocol and sign the informed consent;
- Age of 18-75 years;
- Cytological or histological diagnosis of untreated locally advanced or metastatic hepatocellular carcinoma;
- Diseases are not suitable for radical surgery and/or local treatment, or disease progression occurs after surgery and/or local treatment;
- At least one measurable lesion as defined by RECIST 1.1 criteria and untreated lesion;
- Patients who have received previous local treatment (e.g., radiofrequency ablation, ethanol or acetic acid injection, cryoablation, high intensity focused ultrasound, transcatheter arterial chemoembolization, transcatheter arterial embolization, etc.) are eligible to participate in the study if the target lesion has not received local treatment before, or if the target lesion within the scope of local treatment has subsequently developed on the basis of RECIST v1.1;
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- ECOG performance status of 0-1;
- Child-Pugh A;
- Bone marrow function: absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥75×109 /L, hemoglobin(HB) ≥90 g/L;
- alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤5 x upper limit of normal range (ULN);total bilirubin (TBIL)≤3 x upper limit of normal range (ULN);Creatinine(Cr)≤1.5 x upper limit of normal range(ULN);Serum albumin (> 28 g/L) (2.8 g/dL);Patients not receiving anticoagulation therapy: INR or aPTT < 2 *ULN;Urinary cellulose test paper results Proteinuria < 2 (7 days before the start of treatment);Patients with baseline cellulose test paper urine test results (> 2 proteinuria) should collect 24-hour urine, and then must confirm that the 24-hour urinary protein content is less than 1 g;
- HIV test results were negative at screening;
- Records of virological status of hepatitis, confirmed by serological tests of HBV and HCV;
- Patients with active hepatitis B virus (HBV) infection:HBV DNA < 500 IU/mL was obtained within 28 days before the start of the study, and received at least 14 days of anti-HBV treatment (based on local standard treatment, such as entecavir) prior to the study, and was willing to continue treatment during the study period.
Who cannot join
- Systemic HCC treatment has been received in the past;
- History of primary immunodeficiency is known;
- It is known to have active tuberculosis;
- History of allogeneic organ transplantation and hematopoietic stem cell transplantation is known;
- It is known that there is a history of human immunodeficiency virus (HIV) infection (that is, HIV antibody positive);
- Severe allergic/allergic reactions to humanized antibodies or fusion proteins were observed;
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- It is known to have hypersensitivity to any component contained in Endor preparations;
- Initial serious heart disease patients include congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe valvular disease and refractory hypertension;
- History of PIA meningitis;
- Major cardiovascular diseases (e.g. New York Heart Association Grade II or more serious heart disease, myocardial infarction or cerebrovascular accident), unstable arrhythmia or unstable angina pectoris, occurred within three months before the start of treatment;
- Major surgical treatments (except diagnosis) were received within 4 weeks before the start of the study, or major surgical treatments were expected during the study period;
- Other malignant tumors were diagnosed within 5 years before the first administration. Exceptions included radical basal cell carcinoma, squamous cell carcinoma, adequately treated cervical cancer in situ, and localized prostate cancer;
- Active infections requiring systemic treatment;
- Fiberboard HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC are known;
- Moderate or severe ascites;
- History of hepatic encephalopathy;
- Patients with a history of HCV infection but negative results of HCV RNA PCR may consider that they are not infected with HCV;
- Systemic glucocorticoid therapy or any other form of immunosuppressive therapy is being administered within 7 days prior to the diagnosis of immunodeficiency or the study's first administration; physiological doses of glucocorticoid (<10mg/day prednisone or equivalent) are allowed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430000
Xianglin Yuan, MD,PHD, 8627-83663406, xlyuan1020@163.com
Yanmei Zou, MD,PHD, 8627-83663406, zouyanmei0101@126.com
About this study
Official title: A Single Arm, Observational Clinical Trial to Evaluate the Efficacy and Safety of Combination Treatment With Sintilimab Injection Plus Endostar in Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
It is a a single arm, observational clinical trial to evaluate the efficacy and safety of combination treatment with sintilimab injection plus endostar in untreated locally advanced or metastatic hepatocellular carcinoma.
Read the detailed description
For the first line treatment with untreated locally advanced or metastatic hepatocellular carcinoma, sintilimab injection plus endostar might be one of the treatment choices.
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Keywords
- Hepatocellular Carcinoma, Sintilimab Injection, Endostar
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
The rate of participants that achieve either a complete response (CR) or a partial response (PR).
Measured: up to 3 years
PFS
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first
Measured: up to 3 years
Secondary outcomes (3)
OS
Overall survival is defined as time from the start of treatment until death due to any reason.
Measured: up to 3 years
DOR
The time between the first recorded and objective remission to the first onset of disease progression or all-cause death (whichever happens first)
Measured: up to 3 years
Safety as measured by number and grade of adverse events
Summary adverse events according to NCI-CTCAE 4.03
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start5 Mar 2019
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Non-resectableStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianglin Yuan, Huazhong University of Science and Technology
- Investigators
- Xianglin Yuan, MD,PhD, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881501
- Sponsor's protocol ID
- TJCC009
- Status last verified
- Mar 2019
- First submitted
- 14 Mar 2019
- Last updated
- 19 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Observational Clinical Trial to Evaluate the Efficacy and Safety of Combination Treatment With Sintilimab Injection Plus Endostar in Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03881501
- Acronym / sponsor ID
- TJCC009
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Keywords
- Hepatocellular Carcinoma, Sintilimab Injection, Endostar
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 19 Mar 2019 (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.
It is a a single arm, observational clinical trial to evaluate the efficacy and safety of combination treatment with sintilimab injection plus endostar in untreated locally advanced or metastatic hepatocellular carcinoma.
Detailed description
For the first line treatment with untreated locally advanced or metastatic hepatocellular carcinoma, sintilimab injection plus endostar might be one of the treatment choices.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
Key inclusion criteria (13 listed)
- Able and willing to comply with the study plans in this protocol and sign the informed consent;
- Age of 18-75 years;
- Cytological or histological diagnosis of untreated locally advanced or metastatic hepatocellular carcinoma;
- Diseases are not suitable for radical surgery and/or local treatment, or disease progression occurs after surgery and/or local treatment;
- At least one measurable lesion as defined by RECIST 1.1 criteria and untreated lesion;
Key exclusion criteria (18 listed)
- Systemic HCC treatment has been received in the past;
- History of primary immunodeficiency is known;
- It is known to have active tuberculosis;
- History of allogeneic organ transplantation and hematopoietic stem cell transplantation is known;
- It is known that there is a history of human immunodeficiency virus (HIV) infection (that is, HIV antibody positive);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ORR
Time frame: up to 3 years
The rate of participants that achieve either a complete response (CR) or a partial response (PR).
PFS
Time frame: up to 3 years
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first
3 secondary outcomes
OS
Time frame: up to 3 years
DOR
Time frame: up to 3 years
Safety as measured by number and grade of adverse events
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
Xianglin Yuan, MD,PhD study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma Non-resectable, run by Huazhong University of Science and Technology 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 13 inclusion and 18 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 19 Mar 2019. 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.
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 Xianglin Yuan, MD,PhD (8627-83663406, xlyuan1020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to 3 years). The study lists 2 primary outcomes in all. 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 19 Mar 2019.