- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03881501
Evaluate the Treatment With Sintilimab Injection Plus Endostar in Hepatocellular Carcinoma
March 16, 2019 updated by: Xianglin Yuan, Huazhong University of Science and Technology
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.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
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 Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430000
- Recruiting
- Tongji Hospital
-
Contact:
- Xianglin Yuan, MD,PHD
- Phone Number: 8627-83663406
- Email: xlyuan1020@163.com
-
Contact:
- Yanmei Zou, MD,PHD
- Phone Number: 8627-83663406
- Email: zouyanmei0101@126.com
-
-
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
Sampling Method
Non-Probability Sample
Study Population
Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
Description
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
- 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;
- 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.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR
Time Frame: up to 3 years
|
The rate of participants that achieve either a complete response (CR) or a partial response (PR).
|
up to 3 years
|
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
|
up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS
Time Frame: up to 3 years
|
Overall survival is defined as time from the start of treatment until death due to any reason.
|
up to 3 years
|
Safety as measured by number and grade of adverse events
Time Frame: up to 3 years
|
Summary adverse events according to NCI-CTCAE 4.03
|
up to 3 years
|
DOR
Time Frame: up to 3 years
|
The time between the first recorded and objective remission to the first onset of disease progression or all-cause death (whichever happens first)
|
up to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Xianglin Yuan, MD,PhD, Tongji Hospital
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)
March 5, 2019
Primary Completion (Anticipated)
March 1, 2020
Study Completion (Anticipated)
March 1, 2020
Study Registration Dates
First Submitted
March 14, 2019
First Submitted That Met QC Criteria
March 16, 2019
First Posted (Actual)
March 19, 2019
Study Record Updates
Last Update Posted (Actual)
March 19, 2019
Last Update Submitted That Met QC Criteria
March 16, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TJCC009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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