Hepatocellular CarcinomaNCT06542796
Study on the Classification of Comprehensive Treatment Effect of Hepatocellular Carcinoma
A study testing Immunotherapy combined with targeted therapy and Standard treatment plan in people with Hepatocellular Carcinoma and Immunotherapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Through a retrospective study of patients who underwent comprehensive treatment for hepatocellular carcinoma at the Second Affiliated Hospital of Zhejiang University, we explored the risk factors related to the sensitivity of comprehensive treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Immunotherapy
- What is being tested?
- Immunotherapy combined with targeted therapy and Standard treatment plan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with advanced hepatocellular carcinoma
Who cannot join
- Have comorbidities of severe diabetes, heart failure, liver and/or kidney failure
- Have a history of schizophrenia
- Have a history of other malignant tumors or metastatic liver tumors discovered after surgery
- Received anti-tumor drugs for other diseases
- Special groups such as pregnant and lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
2ndAffiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Human Subject Research Ethics Committee, +86 0571 87783759, keyanlunli_zheer@163.com
About this study
Through a retrospective study of patients who underwent comprehensive treatment for hepatocellular carcinoma at the Second Affiliated Hospital of Zhejiang University, we explored the risk factors related to the sensitivity of comprehensive treatment. We used the PD-L1 expression level of patients before comprehensive treatment，characteristic morphology of tertiary lymphoid structures, as well as other parameters, are used to construct a liver cancer comprehensive treatment efficacy evaluation model. Using this liver cancer comprehensive treatment efficacy evaluation model, we conducted a randomized controlled trial on whether to receive comprehensive treatment for liver cancer patients to verify the accuracy and practical value of the model.
Read the detailed description
As of 2020, hepatocellular carcinoma (HCC) is the sixth leading cause of cancer-related deaths, making it one of the world's major public health issues. The incidence of HCC is increasing year by year, from 14 million cases worldwide in 2012 to an estimated 22 million cases by 2030. Most HCC patients are not diagnosed until late stages, thus missing the optimal treatment window. In recent years, comprehensive therapy with immune targeting as the core has made breakthrough progress in the treatment of advanced liver cancer, bringing good news to patients with advanced liver cancer. Clinical trials have shown that immunotherapy combined with targeted therapy is effective in the treatment of unresectable hepatocellular carcinoma. Patients have significant clinical value. However, the therapeutic effect of immune targeting varies depending on the complex tumor microenvironment of HCC. Therefore, there is an urgent need to establish an efficacy evaluation model for comprehensive treatment to accurately classify and stratify patients and select the best treatment plan.
Intratumoral T cell and B cell infiltration has been extensively studied and is associated with good prognosis in most tumors. In recent years, tertiary lymphoid structures (TLS) have gradually gained in-depth understanding. Tertiary lymphoid structures are lymphatic aggregates formed at sites of inflammation in autoimmune diseases, infections, and cancers. They can provide local antigen presentation sites and generate effector T cells and central memory T cells, thereby providing humoral and cellular anti-tumor specificity. Sexual immune response provides an important microenvironment. Further studies have shown that the presence of intratumoral TLS is associated with reduced risk of recurrence and improved survival in most solid tumors, and mature TLS was found to be a key site of tumor-specific immune responses in pancreatic ductal adenocarcinoma, which is consistent with immunotherapy. related to efficacy. In addition, more and more studies have found that clinical characteristics such as vascular endothelial growth factor (VEGF) levels are related to the effect of comprehensive treatment of liver cancer. Studies have shown that plasma VEGF levels are significantly related to the survival rate of patients with hepatocellular carcinoma, and VEGF levels are important for their prognosis. Stratification has excellent clinical value.
Therefore, this study focused on the characteristic parameters of liver cancer tumor microenvironment such as TLS, PD-L1 expression level, and VEGF level to construct a liver cancer comprehensive treatment efficacy evaluation model to guide the selection of treatment options.
The predictive accuracy of the constructed model was determined by measuring the specificity, sensitivity, and area under the receiver operating characteristic (ROC) curve in the validation sample. Discrimination refers to the ability of a predictive model to accurately identify patients at low and high risk for the event under investigation, usually expressed as the area under the ROC curve. A predictive model with an ROC of 0.75 is considered to have good discrimination, whereas an area of 0.5 is considered equivalent to a coin toss.
- Conditions
- Hepatocellular Carcinoma, Immunotherapy
- Being tested
- Immunotherapy combined with targeted therapy, Standard treatment plan
- Keywords
- Tertiary Lymphoid Structures, Vascular Endothelial Growth Factor A, Immunotherapy
- Medical subject headings
- Carcinoma, Hepatocellular, Tertiary Lymphoid Structures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunotherapy combined with targeted therapyProcedure or surgery
Immunotherapy combined with targeted therapy
Standard treatment planOther
Standard treatment plan
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive treatment group | Experimental | Immunotherapy combined with targeted therapy Receives: Procedure: Immunotherapy combined with targeted therapy |
| non-comprehensive treatment group | Active comparator | Standard treatment plan Receives: Other: Standard treatment plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy of patient treatment
The treatment effects were assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) proposed by the American Cancer Institute. The treatment effects were divided into complete remission (CR), partial remission (PR), stable disease (SD), progressive disease (PD), objective response rate (ORR) = CR + PR, and disease control rate (DCR) = CR + PR + SD. All the data in this study were analyzed and processed with statistical software SPSS 24.0. The measurement data were expressed in mean ± SD (±s). When the measurement data conform to the normal distribution and the variance was homogeneous, a t-test was adopted. The counting data were described by N and %. The disordered classification data were compared by the χ2 test or Fisher's exact probability method. All tests were two-sided, and the difference was statistically significant when P < 0.05.
Measured: Long-term follow-up of patients after treatment through the study completion, an average of 1 year
The predictive accuracy of the constructed model
The predictive accuracy of the constructed model was determined by measuring the specificity, sensitivity, and area under the receiver operating characteristic (ROC) curve in the validation sample. Discrimination refers to the ability of a predictive model to accurately identify patients at low and high risk for the event under investigation, usually expressed as the area under the ROC curve. A predictive model with an ROC of 0·75 is considered to have good discrimination, whereas an area of 0·5 is considered equivalent to a coin toss.All the data in this study were analyzed and processed with statistical software SPSS 24.0. All tests were two-sided, and the difference was statistically significant when P < 0.05.
Measured: Long-term follow-up of patients after treatment through the study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Sep 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542796
- Sponsor's protocol ID
- 2024-0318
- Status last verified
- Mar 2024
- First submitted
- 4 Jun 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Classification of Comprehensive Treatment Effect of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06542796
- Acronym / sponsor ID
- 2024-0318
- Conditions
- Hepatocellular Carcinoma, Immunotherapy
- Keywords
- Tertiary Lymphoid Structures, Vascular Endothelial Growth Factor A, Immunotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 7 Aug 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.
Through a retrospective study of patients who underwent comprehensive treatment for hepatocellular carcinoma at the Second Affiliated Hospital of Zhejiang University, we explored the risk factors related to the sensitivity of comprehensive treatment. We used the PD-L1 expression level of patients before comprehensive treatment，characteristic morphology of tertiary lymphoid structures, as well as other parameters, are used to construct a liver cancer comprehensive treatment efficacy evaluation model. Using this liver cancer comprehensive treatment efficacy evaluation model, we conducted a randomized controlled trial on whether to receive comprehensive treatment for liver cancer patients to verify the accuracy and practical value of the model.
Detailed description
As of 2020, hepatocellular carcinoma (HCC) is the sixth leading cause of cancer-related deaths, making it one of the world's major public health issues. The incidence of HCC is increasing year by year, from 14 million cases worldwide in 2012 to an estimated 22 million cases by 2030. Most HCC patients are not diagnosed until late stages, thus missing the optimal treatment window. In recent years, comprehensive therapy with immune targeting as the core has made breakthrough progress in the treatment of advanced liver cancer, bringing good news to patients with advanced liver cancer. Clinical trials have shown that immunotherapy combined with targeted therapy is effective in the treatment of unresectable hepatocellular carcinoma. Patients have significant clinical value. However, the therapeutic effect of immune targeting varies depending on the complex tumor microenvironment of HCC. Therefore, there is an urgent need to establish an efficacy evaluation model for comprehensive treatment to accurately classify and stratify patients and select the best treatment plan.
Intratumoral T cell and B cell infiltration has been extensively studied and is associated with good prognosis in most tumors. In recent years, tertiary lymphoid structures (TLS) have gradually gained in-depth understanding. Tertiary lymphoid structures are lymphatic aggregates formed at sites of inflammation in autoimmune diseases, infections, and cancers. They can provide local antigen presentation sites and generate effector T cells and central memory T cells, thereby providing humoral and cellular anti-tumor specificity. Sexual immune response provides an important microenvironment. Further studies have shown that the presence of intratumoral TLS is associated with reduced risk of recurrence and improved survival in most solid tumors, and mature TLS was found to be a key site of tumor-specific immune responses in pancreatic ductal adenocarcinoma, which is consistent with immunotherapy. related to efficacy. In addition, more and more studies have found that clinical characteristics such as vascular endothelial growth factor (VEGF) levels are related to the effect of comprehensive treatment of liver cancer. Studies have shown that plasma VEGF levels are significantly related to the survival rate of patients with hepatocellular carcinoma, and VEGF levels are important for their prognosis. Stratification has excellent clinical value.
Therefore, this study focused on the characteristic parameters of liver cancer tumor microenvironment such as TLS, PD-L1 expression level, and VEGF level to construct a liver cancer comprehensive treatment efficacy evaluation model to guide the selection of treatment options.
The predictive accuracy of the constructed model was determined by measuring the specificity, sensitivity, and area under the receiver operating characteristic (ROC) curve in the validation sample. Discrimination refers to the ability of a predictive model to accurately identify patients at low and high risk for the event under investigation, usually expressed as the area under the ROC curve. A predictive model with an ROC of 0.75 is considered to have good discrimination, whereas an area of 0.5 is considered equivalent to a coin toss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive treatment group | Experimental | Procedure: Immunotherapy combined with targeted therapyImmunotherapy combined with targeted therapy |
| non-comprehensive treatment group | Active comparator | Other: Standard treatment planStandard treatment plan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with advanced hepatocellular carcinoma
Key exclusion criteria (5 listed)
- Have comorbidities of severe diabetes, heart failure, liver and/or kidney failure
- Have a history of schizophrenia
- Have a history of other malignant tumors or metastatic liver tumors discovered after surgery
- Received anti-tumor drugs for other diseases
- Special groups such as pregnant and lactating women.
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 combined with targeted therapyImmunotherapy combined with targeted therapy | Procedure or surgery | Comprehensive treatment group |
| Standard treatment planStandard treatment plan | Other | non-comprehensive treatment group |
Primary outcome
Evaluation of the efficacy of patient treatment
Time frame: Long-term follow-up of patients after treatment through the study completion, an average of 1 year
The treatment effects were assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) proposed by the American Cancer Institute. The treatment effects were divided into complete remission (CR), partial remission (PR), stable disease (SD), progressive disease (PD), objective response rate (ORR) = CR + PR, and disease control rate (DCR) = CR + PR + SD. All the data in this study were analyzed and processed with statistical software SPSS 24.0. The measurement data were expressed in mean ± SD (±s). When the measurement data conform to the normal distribution and the variance was homogeneous, a t-test was adopted. The counting data were described by N and %. The disordered classification data were compared by the χ2 test or Fisher's exact probability method. All tests were two-sided, and the difference was statistically significant when P < 0.05.
The predictive accuracy of the constructed model
Time frame: Long-term follow-up of patients after treatment through the study completion, an average of 1 year
The predictive accuracy of the constructed model was determined by measuring the specificity, sensitivity, and area under the receiver operating characteristic (ROC) curve in the validation sample. Discrimination refers to the ability of a predictive model to accurately identify patients at low and high risk for the event under investigation, usually expressed as the area under the ROC curve. A predictive model with an ROC of 0·75 is considered to have good discrimination, whereas an area of 0·5 is considered equivalent to a coin toss.All the data in this study were analyzed and processed with statistical software SPSS 24.0. All tests were two-sided, and the difference was statistically significant when P < 0.05.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No
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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.
2ndAffiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunotherapy combined with targeted therapy and Standard treatment plan in people with Hepatocellular Carcinoma and Immunotherapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 10 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the efficacy of patient treatment (time frame: Long-term follow-up of patients after treatment through the study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 10 Feb 2025.