Exploring targeted therapy and immunotherapy for advanced liver and biliary tumors
Real-world Study for Targeted Therapy and Immunotherapy in Patients With Advanced Hepatobiliary Tumors: a Multi-centers, Open-assess Observational Study.
This study is testing whether new targeted therapies and immunotherapies can help people with advanced liver and biliary tumors live longer and feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | lenvatinib, apatinib, chemotherapy, immunotherapy |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT03892577 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enroll approximately 2000 patients with advanced hepatobiliary tumors across 20 research centers. It will investigate the effectiveness of targeted therapies and immunotherapies in improving survival and quality of life while assessing the safety of these treatments. Patients will be monitored monthly, and data on genetic variations will be collected to analyze correlations with treatment outcomes. The study plans to conduct interim analyses as enrollment progresses over a period of five years.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced liver or biliary tumors who are not candidates for radical surgery.
Not a fit: Patients with early-stage tumors or those who can undergo radical surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and quality of life for patients with advanced hepatobiliary tumors.
How similar studies have performed: Other studies have shown promise with targeted therapies and immunotherapies in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing
- Chinese Academy of Medical Sciences & Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Xiaobo Yang
- Email: zhaoht@pumch.cn
- Phone: 010-69156043
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.