Symptoms and General Pathology

All Conditions

Behaviors and Mental Disorders

Disease Progression

Quality of Life

Antineoplastic Agents

All Drugs and Chemicals

Apatinib

Lenvatinib

Angiogenesis Inhibitors

Immunomodulating Agents

Sorafenib

Immunologic Factors

2000 patients with advanced hepatobiliary tumors will be enrolled and the enroll patients should be treat with any type of the following three treatment program:

1. Monotherapy or combination therapy with the targeted drug related to genetic variation of the subject;
2. Treatment with pan-target anti-angiogenic drugs, such as sorafenib, regorafenib, lenvatinib, apatinib, etc;
3. Immunotherapy or immunotherapy combined with targeted therapy or (and) chemotherapy.

Therapeutic regimens are based on the clinicopathological features, genomic alterations, advices from multidisciplinary tumor board and willings from patients.

Precision oncology including targeted therapy and immunotherapy

Xiaobo Yang

Haitao Zhao

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.

This trial is a multicenter, non-random, open and observational real-world study. It is estimated that 2000 patients with advanced hepatobiliary tumors will be enrolled in about 20 research centers. And it is planned to complete the enrollment within 2 years and it is expected that all enrolled subjects will reach the observation end point in 5 years.

After primary screening of all the patients, the investigators will further collect next-generation sequence(NGS) data and immunohistochemical data from the subjects, and enroll patients with any type of the following three treatment program: 1. Monotherapy or combination therapy with the targeted drug related to genetic variation of the subject; 2. Treatment with pan-target anti-angiogenic drugs, such as sorafenib, regorafenib, lenvatinib, apatinib, etc; 3. Immunotherapy or immunotherapy combined with targeted therapy.

The investigators will collect subjects' data from assessment centers each month and the efficacy, quality of life, and safety of treatment will be evaluated.

This trial plans to conduct an interim analysis and final analysis after collecting 500 cases, 1000 cases, and 2000 subjects, 3000 subjects,and explore the clinical application value of targeted therapy and immunotherapy in advanced hepatobiliary tumors in real world.

Real-world Study for Patients With Advanced Hepatobiliary Tumors

Real-world Study for Targeted Therapy and Immunotherapy in Patients With Advanced Hepatobiliary Tumors: a Multi-centers, Open-assess Observational Study.

Time from the date of initial treatment to death for any cause.

A duration from the date of initial treatment with apatinib to disease progression (as defined by RECIST) or death.

Percentage of subjects with complete response and partial response.

Percentage of subjects with complete remission, partial remission, or stable disease during treatment or within 30 days of termination of test drug.

Percentage of subjects who develop any adverse events (CTCAE 4.0).

The life quality of every subject will be assessed every 3 months according to the 45-item FACT-Hep questionnaire, which assesses generic HRQL concerns and disease-specific issues.

Spots Global Cancer Trial Database for precision oncology including targeted therapy and immunotherapy