Evaluate the Treatment With Sintilimab Injection Plus Endostar in Hepatocellular Carcinoma (NCT03881501) | Clinical Trial Compass
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Evaluate the Treatment With Sintilimab Injection Plus Endostar in Hepatocellular Carcinoma
China2 participantsStarted 2019-03-05
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Exclusion criteria
. Systemic HCC treatment has been received in the past;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
ORR
Timeframe: up to 3 years
2
PFS
Timeframe: up to 3 years
Trial details
NCT IDNCT03881501
SponsorHuazhong University of Science and Technology