Anti-angiogenesis Combined With PD-1/PD-L1 Therapy in Patients With Advanced Liver Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Follow-up Registration Management of Anti-angiogenesis Combined With PD-1/PD-L1 Therapy in Patients With Advanced Liver Cancer

Conditions
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Carcinoma, Hepatocellular

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: ≥ 18 years old, male or female; Patients diagnosed with advanced liver cancer, including barcelona stage B, C or Chinese liver cancer guidelines stage IIa, IIb, IIIa, IIIb liver cancer patients; doctors evaluate patients who can benefit from anti-angiogenesis targeted therapy; patients voluntarily join the program and sign informed consent. Exclusion criteria: The above selection criteria are not met

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| those with anti-angiogenesis combined with PD-1/PD-L1 therapy<br>This study includes patients with advanced liver cancer who can benefit from anti-angiogenesis combined PD-1/PD-L1 treatment and observes the relationship between overall survival and their therpay. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival | Progression-free survival (PFS) is defined as the time from random assignment in a clinical trial to disease progression or death from any cause. | 3-4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | 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. | 3-4 weeks | 
| Objective Response Rate | 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. | 3-4 weeks | 
| disease control rate | 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. | 3-4 weeks |