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

Carcinoma, Hepatocellular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05383066
• Other study ID #: 2021keyan055
• Status: Not yet recruiting
• Start date: May 20, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2022
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 490
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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