Real-world Study for Patients With Advanced Hepatobiliary Tumors

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Mar 26, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how well certain treatments can help people with advanced liver and bile duct cancers, also known as hepatobiliary tumors. Specifically, it looks at whether targeted therapies (medications that focus on specific cancer cells) and immunotherapies (treatments that help the body’s immune system fight cancer) can improve survival rates, quality of life, and overall safety for patients. The researchers are also interested in how genetic differences among patients may affect how well these treatments work.

To be eligible for this study, participants need to be at least 18 years old and have a confirmed diagnosis of advanced liver or biliary cancer that is not suitable for surgery. They should have a life expectancy of at least six months and must have measurable cancer lesions. Patients who are currently receiving palliative care, which is treatment aimed at relieving symptoms rather than curing the disease, may qualify. If you choose to participate, you'll be closely monitored during the trial, and your experience will help researchers learn more about these treatments and their effects on patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects must meet all of the following criteria：
• • 1. ≥18 years old, gender is not limited, and life expectancy is at least 6 months.
• • 2. 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).
• • 3. The Barcelona staging classification: class B-C.
• • 4. Child-Pugh classification: class A-B.
• • 5. At least one measurable lesion (RECIST v1.1)
• • 6. Unable to perform radical surgery or patient refuse surgery.
• 7. Subjects need palliative treatment, and have received or are undergoing any of the following three treatments:
• • Monotherapy or combination therapy with targeted drug associated with genetic variation in the subject.
• • Or, treat with pan-target anti-vascular drugs, such as sorafenib, regorafenib, lenvatinib, apatinib.
• • Or, immunotherapy or immunotherapy combined with targeted therapy or (and) classical chemotherapy.
• • 8. Subjects volunteer to participate in the study and sign informed consent.
• Exclusion Criteria:
• Patients with one or more of the following criteria should be excluded:
• • 1. Patients with early hepatobiliary tumor.
• • 2. The Barcelona staging classification: class A.
• • 3. Child-Pugh classification: class C.
• • 4. Radical surgical resection.
• • 5. CT or MRI shows unclear tumor boundary or no measurable lesions (RECIST v1.1).
• • 6. Drug abuse, or any medical, psychological, or social condition that may affect the study, patient compliance, or even compromise the safety of the patient.
• • 7. 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.
• • 8. Mental or medical instability makes patients unable or unwilling to sign informed consent.
• • 9. Patients after comprehensive assessment are considered by the investigators to be unsuitable for participating in the study.