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

Peking University First Hospital490 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

490

Conditions

Carcinoma, Hepatocellular

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 3-4 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 3-4 weeks

Data from ClinicalTrials.gov

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