Anti-angiogenesis Combined With PD-1/PD-L1 Therapy in Patients With Advanced Liver Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| those with anti-angiogenesis combined with PD-1/PD-L1 therapy 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. |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age: ≥ 18 years old, male or female;
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Patients diagnosed with advanced liver cancer, including barcelona stage B, C or Chinese liver cancer guidelines stage IIa, IIb, IIIa, IIIb liver cancer patients;
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doctors evaluate patients who can benefit from anti-angiogenesis targeted therapy;
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patients voluntarily join the program and sign informed consent.
Exclusion criteria:
The above selection criteria are not met
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Peking University First Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021keyan055