Real-world Study for Patients With Advanced Hepatobiliary Tumors (NCT03892577) | Clinical Trial Compass
UnknownNot Applicable
Real-world Study for Patients With Advanced Hepatobiliary Tumors
China3,000 participantsStarted 2017-07-01
Plain-language summary
The investigators design a large sample size study in the real-world to explore whether targeted therapy and immunotherapy can improve the survival, quality of life and drug safety of patients with advanced hepatobiliary tumors, and analyze the correlation between genetic variation and the effectiveness of therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ≥18 years old, gender is not limited, and life expectancy is at least 6 months.
✓. Diagnosed as primary liver cancer or biliary malignant tumor by histopathology or confirmed by imaging as HCC (by the American Association for the Study of Liver Diseases or standard for the diagnosis and treatment of primary liver cancer 2017 in China).
✓. The Barcelona staging classification: class B-C.
✓. Child-Pugh classification: class A-B.
✓. At least one measurable lesion (RECIST v1.1)
✓. Unable to perform radical surgery or patient refuse surgery.
✓. Subjects need palliative treatment, and have received or are undergoing any of the following three treatments:
✓. Subjects volunteer to participate in the study and sign informed consent.
Exclusion criteria
✕. Patients with early hepatobiliary tumor.
✕. The Barcelona staging classification: class A.
✕. Child-Pugh classification: class C.
✕. Radical surgical resection.
✕. CT or MRI shows unclear tumor boundary or no measurable lesions (RECIST v1.1).
. Drug abuse, or any medical, psychological, or social condition that may affect the study, patient compliance, or even compromise the safety of the patient.
✕. Conduct other experimental drug treatments other than this test within 4 weeks before the start of the study; or participate in another clinical study that has an impact on the results of this study.
✕. Mental or medical instability makes patients unable or unwilling to sign informed consent.