Hepatocellular CarcinomaPhase 2NCT06029829
The Clinical Significance of Peripheral Blood T Lymphocyte PD-1 Expression and T Cell Subset Distribution.
A Phase 2 study testing Sintilimab in people with Hepatocellular Carcinoma, run by Xin-Hua Xu at 1 site in China.
Trial summary
Providing more theoretical basis for the prediction of the efficacy of advanced HCC and helping select better advantaged population of HCC immunotherapy to maximize the benefits of patients By exploring the relationship between the changes of PD-1 expression in peripheral blood T lymphocytes and the clinical efficacy… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Sintilimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2023to 30 Jun 2024
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to participate in the clinical study, fully understand and be informed about the study, and sign the informed consent form;
- Age between 18 and 75 years, male or female;
- Strictly meet the clinical diagnostic criteria for hepatocellular carcinoma (HCC), confirmed by histology or cytology, with at least one lesion meeting the RECIST 1.1 criteria on CT or MRI examination;
- No prior targeted therapy, immunotherapy, or systemic chemotherapy for liver cancer before admission;
- Child-Pugh A liver function; Barcelona Clinic Liver Cancer (BCLC) stage B or C;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Normal function of major organs;
- Expected survival time of at least 12 weeks or more.
Who cannot join
- Patients who have not previously received treatment with Sintilimab or any other PD-L1 or PD-1 antagonist;
- Patients with any active autoimmune disease or a history of autoimmune disease, or a history of immunodeficiency;
- Patients requiring the use of immunosuppressive drugs;
- Known history of allergy to the formulation of Sintilimab or any other component of the antibody formulation;
- Patients with other malignant tumors.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University
Yichang, Hubei, 443003
Xinhua Xu, +8613986747496 ext. +8613986747496, 2732774352@qq.com
About this study
Official title: The Clinical Value of Peripheral Blood T Lymphocyte PD-1 Expression and T Cell Subset Distribution in the Immunotherapy of Advanced Primary HCC Patients.
Providing more theoretical basis for the prediction of the efficacy of advanced HCC and helping select better advantaged population of HCC immunotherapy to maximize the benefits of patients By exploring the relationship between the changes of PD-1 expression in peripheral blood T lymphocytes and the clinical efficacy before and after the use of PD-1 / PD-L1 inhibitors.
Read the detailed description
Exploring the expression of peripheral blood T lymphocyte PD-1 from an immunological perspective as a potential reference marker for selecting immunotherapy in advanced HCC patients, and elucidating the relationship between the level of peripheral blood T lymphocyte PD-1 expression and survival outcomes after receiving immunotherapy. Additionally, investigating whether there is consistency between the expression levels of PD-1 and PD-L1 and their impact on patients. Furthermore, exploring the correlation between the distribution of T cell subsets and the efficacy of immunotherapy to provide new theoretical evidence for the selection of target populations for immunotherapy and new clinical screening indicators for patient prognosis assessment.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Sintilimab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Any first-line treatment that includes immunotherapy、 Chemotherapy and Anti-angiogenesis Therapy
| Study group | Role | What they receive |
|---|---|---|
| Immunomonotherapy plus Chemotherapy plus Anti-angiogenesis Therapy | Experimental | Any first-line treatment that includes immunotherapy、 Chemotherapy and Anti-angiogenesis Therapy Receives: Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Progression Free Survival (PFS) Regimen using RECIST 1.1.
PFS was defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start12 Jan 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xin-Hua Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xin-Hua Xu, China Three Gorges University, Yichang, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029829
- Sponsor's protocol ID
- CTGU008
- Status last verified
- Sep 2023
- First submitted
- 26 Aug 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Value of Peripheral Blood T Lymphocyte PD-1 Expression and T Cell Subset Distribution in the Immunotherapy of Advanced Primary HCC Patients.
- ClinicalTrials.gov ID
- NCT06029829
- Acronym / sponsor ID
- CTGU008
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xin-Hua XuUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 8 Sep 2023 (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.
Providing more theoretical basis for the prediction of the efficacy of advanced HCC and helping select better advantaged population of HCC immunotherapy to maximize the benefits of patients By exploring the relationship between the changes of PD-1 expression in peripheral blood T lymphocytes and the clinical efficacy before and after the use of PD-1 / PD-L1 inhibitors.
Detailed description
Exploring the expression of peripheral blood T lymphocyte PD-1 from an immunological perspective as a potential reference marker for selecting immunotherapy in advanced HCC patients, and elucidating the relationship between the level of peripheral blood T lymphocyte PD-1 expression and survival outcomes after receiving immunotherapy. Additionally, investigating whether there is consistency between the expression levels of PD-1 and PD-L1 and their impact on patients. Furthermore, exploring the correlation between the distribution of T cell subsets and the efficacy of immunotherapy to provide new theoretical evidence for the selection of target populations for immunotherapy and new clinical screening indicators for patient prognosis assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunomonotherapy plus Chemotherapy plus Anti-angiogenesis Therapy | Experimental | Drug: SintilimabAny first-line treatment that includes immunotherapy、 Chemotherapy and Anti-angiogenesis Therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing to participate in the clinical study, fully understand and be informed about the study, and sign the informed consent form;
- Age between 18 and 75 years, male or female;
- Strictly meet the clinical diagnostic criteria for hepatocellular carcinoma (HCC), confirmed by histology or cytology, with at least one lesion meeting the RECIST 1.1 criteria on CT or MRI examination;
- No prior targeted therapy, immunotherapy, or systemic chemotherapy for liver cancer before admission;
- Child-Pugh A liver function; Barcelona Clinic Liver Cancer (BCLC) stage B or C;
Key exclusion criteria (5 listed)
- Patients who have not previously received treatment with Sintilimab or any other PD-L1 or PD-1 antagonist;
- Patients with any active autoimmune disease or a history of autoimmune disease, or a history of immunodeficiency;
- Patients requiring the use of immunosuppressive drugs;
- Known history of allergy to the formulation of Sintilimab or any other component of the antibody formulation;
- Patients with other malignant tumors.
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 |
|---|---|---|
| SintilimabAny first-line treatment that includes immunotherapy、 Chemotherapy and Anti-angiogenesis Therapy | Drug | Immunomonotherapy plus Chemotherapy plus Anti-angiogenesis Therapy |
Primary outcome
Compare Progression Free Survival (PFS) Regimen using RECIST 1.1.
Time frame: 24 months
PFS was defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab in people with Hepatocellular Carcinoma, run by Xin-Hua Xu 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 8 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: status not confirmed, as of the sponsor's last update on 8 Sep 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xinhua Xu, Master (13986747496 ext. 86, 2732774352@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare Progression Free Survival (PFS) Regimen using RECIST 1.1. (time frame: 24 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 8 Sep 2023.