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

Not yet recruiting

• Conditions: Carcinoma, Hepatocellular

• Registration Number: NCT05383066
• Lead Sponsor: Peking University First Hospital

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.

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-16
• Study First Submitted QC: 2022-05-16
• Last Update Submitted: 2022-05-16
• Study First Posted: 2022-05-19
• Last Update Posted: 2022-05-19
• Study Start: 2022-05-20
• Primary Completion: 2023-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 490

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.