Evaluate the Treatment With Sintilimab Injection Plus Endostar in Hepatocellular Carcinoma (NCT03881501) | Clinical Trial Compass
UnknownNot Applicable
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 range18 Years – 75 Years
SexALL
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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;
✕. History of primary immunodeficiency is known;
✕. It is known to have active tuberculosis;
✕
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