Carcinoma, HepatocellularNCT05383066
Anti-angiogenesis Combined With PD-1/PD-L1 Therapy in Patients With Advanced Liver Cancer
An observational study of Carcinoma, Hepatocellular, run by Peking University First Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- How many people
- 490 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2022to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This project is a non-interventional, prospective, multicenter, case follow-up registration management, aiming to observe and explore the impact of real-world anti-angiogenesis targeted therapy on the survival prognosis of patients with advanced liver cancer, and 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 targeted therapy in patients with advanced liver cancer.
Who may be able to join
- 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.
Who cannot join
- The above selection criteria are not met
About this study
Official title: Follow-up Registration Management of Anti-angiogenesis Combined With PD-1/PD-L1 Therapy in Patients With Advanced Liver Cancer
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.
Read the 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.
- Conditions
- Carcinoma, Hepatocellular
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-4 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 3-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start20 May 2022 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383066
- Sponsor's protocol ID
- 2021keyan055
- Status last verified
- May 2022
- First submitted
- 16 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Registration Management of Anti-angiogenesis Combined With PD-1/PD-L1 Therapy in Patients With Advanced Liver Cancer
- ClinicalTrials.gov ID
- NCT05383066
- Acronym / sponsor ID
- 2021keyan055
- Conditions
- Carcinoma, Hepatocellular
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 20 May 2022 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This project is a non-interventional, prospective, multicenter, case follow-up registration management, aiming to observe and explore the impact of real-world anti-angiogenesis targeted therapy on the survival prognosis of patients with advanced liver cancer, and 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 targeted therapy in patients with advanced liver cancer.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- The above selection criteria are not met
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-Free Survival
Time frame: 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.
3 secondary outcomes
Overall survival
Time frame: 3-4 weeks
Objective Response Rate
Time frame: 3-4 weeks
disease control rate
Time frame: 3-4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Hepatocellular, run by Peking University First Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: 3-4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.