Carcinoma, Hepatocellular
Conditions
Brief summary
To observe and explore the effect of anti-angiogenesis combined with PD-1/PD-L1 therapy in the real world on the survival prognosis of patients with advanced liver cancer, and to summarize the treatment experience of a wide range of people.
Detailed description
This project is a non-interventional, prospective, multicenter, case follow-up registry management, aiming to observe and explore the effect of anti-angiogenesis combined with PD-1/PD-L1 therapy in the real world on the survival prognosis of patients with advanced liver cancer, and to summarize the treatment experience of a wide range of people. Therefore, the data collected and reported in this project will reflect the actual efficacy and safety of anti-angiogenesis combined with PD-1/PD-L1 therapy in patients with advanced liver cancer. 490 patients are planned for follow-up, and enrollment is expected for this program to last for 2 years, starting in December 2021 and ending with the last patient enrollment in December 2023. The treatment period was 24 months, and the patient follow-up was 24 months after the last patient was enrolled.
Interventions
None listed
Sponsors
Peking University First Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age: ≥ 18 years old, male or female; 2. Patients diagnosed with advanced liver cancer, including barcelona stage B, C or Chinese liver cancer guidelines stage IIa, IIb, IIIa, IIIb liver cancer patients; 3. doctors evaluate patients who can benefit from anti-angiogenesis targeted therapy; 4. patients voluntarily join the program and sign informed consent.
Exclusion criteria
The above selection criteria are not met
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival | 3-4 weeks | Progression-free survival (PFS) is defined as the time from random assignment in a clinical trial to disease progression or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3-4 weeks | Overall survival was defined as the duration from the date of diagnosis to death or last follow-up, with no restriction on the cause of death. |
| Objective Response Rate | 3-4 weeks | Complete response (CR) + partial response (PR) refers to the use of THE RECIST version 1.1 standard to assess the objective efficacy of tumors, including cases of CR and PR. |
| disease control rate | 3-4 weeks | Complete response (CR) + partial response (PR) + stable (SD), which refers to the percentage of patients with cr, PR, and SD (≥4 weeks) among patients with measurable efficacy. |
Outcome results
None listed