Carcinoma, HepatocellularNCT06205732
A Retrospective Study on the Treatment of Intermediate and Advanced Liver Cancer.
An observational study of Carcinoma, Hepatocellular, run by Qianfoshan Hospital at 1 site in China.
Trial summary
To evaluate the effectiveness of TACE combined with immunotherapy and targeted therapy versus TACE alone in patients with intermediate and advanced liver cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Immunotherapy, targeted therapy.
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 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
- Adult, Older adult
Study population: Patients with intermediate and advanced liver cancer who received TACE combined with immunotherapy and targeted therapy.
Who may be able to join
- ≥18 years old, both men and women
- primary liver cancer confirmed by liver biopsy or history of hepatitis B, AFP, and typical imaging findings
- patients with liver function Child-Pugh A or B (≤8 points)
- BCLC stage B and stage C
- expected survival time ≥8 weeks
- patients with generally good performance status (ECOG PS score 0 or 1)
Who cannot join
- The patient's key data is missing
- liver metastatic cancer confirmed by histology or cytology
- patients who interrupt treatment due to intolerance of adverse drug reactions
- combined with primary malignant tumors of other organs within 5 years; combined with other serious diseases, such as severe heart disease, renal insufficiency, severe infection, bleeding, etc.
- combined with systemic infection, autoimmune disease, or other types of tumors; previous allogeneic bone marrow transplantation or solid organ transplantation
- study participants known to have mental illness
- situations such as drug use or substance abuse
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Qianfoshan Hospital
Jinan, Shandong, 250000
Jing Liang, Dr, +8618663761275, liangjing0531@163.com
About this study
Official title: Retrospective Study and Construction of a Prediction Model for Patients With Intermediate and Advanced Liver Cancer Treated With TACE Combined With Immunotherapy and Targeted Therapy
To evaluate the effectiveness of TACE combined with immunotherapy and targeted therapy versus TACE alone in patients with intermediate and advanced liver cancer.
Read the detailed description
To evaluate the efficacy and safety of TACE combined with immunotherapy and targeted therapy in patients with intermediate and advanced liver cancer. Explore the factors affecting the prognosis of liver cancer treated with TACE combined with immunotherapy and targeted therapy and establish a specific individualized prognostic score and risk stratification model.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Immunotherapy, targeted therapy.
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunotherapy, targeted therapy.Other
Immunotherapy (sintilimab, camrelizumab, tislelizumab, atezolizumab, durvalumab, cardenilumab, and pembrolizumab); targeted therapy (apatinib, lenvatinib, sorafenib, and regorafenib).
| Study group | Role | What they receive |
|---|---|---|
| TACE+PD-(L)1+TKI | Application of TACE, TKI, and immunotherapy in patients with intermediate and advanced liver cancer. Receives: Other: Immunotherapy, targeted therapy. | |
| TACE alone | Application of TACE in patients with intermediate and advanced liver cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free-Survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start1 Jan 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 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 Qianfoshan 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Liang, Dr, Study director, the Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205732
- Sponsor's protocol ID
- YXLL-KY-2023(145)
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 16 Jan 2024
- 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 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study and Construction of a Prediction Model for Patients With Intermediate and Advanced Liver Cancer Treated With TACE Combined With Immunotherapy and Targeted Therapy
- ClinicalTrials.gov ID
- NCT06205732
- Acronym / sponsor ID
- YXLL-KY-2023(145)
- Conditions
- Carcinoma, Hepatocellular
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 Jan 2024 (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 evaluate the effectiveness of TACE combined with immunotherapy and targeted therapy versus TACE alone in patients with intermediate and advanced liver cancer.
Detailed description
To evaluate the efficacy and safety of TACE combined with immunotherapy and targeted therapy in patients with intermediate and advanced liver cancer. Explore the factors affecting the prognosis of liver cancer treated with TACE combined with immunotherapy and targeted therapy and establish a specific individualized prognostic score and risk stratification model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE+PD-(L)1+TKI | – | Other: Immunotherapy, targeted therapy.Application of TACE, TKI, and immunotherapy in patients with intermediate and advanced liver cancer. |
| TACE alone | – | –Application of TACE in patients with intermediate and advanced liver cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with intermediate and advanced liver cancer who received TACE combined with immunotherapy and targeted therapy.
Key inclusion criteria (6 listed)
- ≥18 years old, both men and women
- primary liver cancer confirmed by liver biopsy or history of hepatitis B, AFP, and typical imaging findings
- patients with liver function Child-Pugh A or B (≤8 points)
- BCLC stage B and stage C
- expected survival time ≥8 weeks
Key exclusion criteria (7 listed)
- The patient's key data is missing
- liver metastatic cancer confirmed by histology or cytology
- patients who interrupt treatment due to intolerance of adverse drug reactions
- combined with primary malignant tumors of other organs within 5 years; combined with other serious diseases, such as severe heart disease, renal insufficiency, severe infection, bleeding, etc.
- combined with systemic infection, autoimmune disease, or other types of tumors; previous allogeneic bone marrow transplantation or solid organ transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunotherapy, targeted therapy.Immunotherapy (sintilimab, camrelizumab, tislelizumab, atezolizumab, durvalumab, cardenilumab, and pembrolizumab); targeted therapy (apatinib, lenvatinib, sorafenib, and regorafenib). | Other | TACE+PD-(L)1+TKI |
Primary outcome
Progression-Free-Survival
Time frame: 12 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
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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.
Jing Liang, Dr study director
the Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Hepatocellular, run by Qianfoshan Hospital at 1 site in China.
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 6 inclusion and 7 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 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Jing Liang, Dr (0086-18663761275, liangjing0531@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free-Survival (time frame: 12 months). 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 16 Jan 2024.