HCC - Hepatocellular CarcinomaNCT07117279
A Prospective Observational Cohort Study on Dynamic CD8+ T-cell Profiling and Multi-omics Biomarkers for Predicting Conversion Therapy Response in Unresectable Hepatocellular Carcinoma
An observational study of HCC - Hepatocellular Carcinoma, run by Tongji Hospital.
Trial summary
This study aims to identify early predictors for successful liver cancer treatment conversion. We will track changes in immune cells (CD8+ T-cells) in the blood during chemotherapy infusion (HAIC/TACE) combined with targeted-immunotherapy for 120 patients with unresectable liver cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC - Hepatocellular Carcinoma
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 31 Aug 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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
Study population: Adults with unresectable liver cancer (HCC) who are scheduled to receive HAIC/TACE plus immunotherapy at major hospitals in Shanghai. All participants must have preserved liver function (Child-Pugh A) and at least one measurable tumor. Key requirements include willingness to undergo tumor biopsy before treatment and provide repeated blood samples during therapy. Expected recruitment sources: 1) Liver cancer specialty clinics (majority), 2) Interventional radiology units.
Who may be able to join
- Adults (18-75 years) with histologically confirmed HCC
- At least one measurable lesion ≥10 mm
- Planned HAIC/TACE + immunotherapy regimen
- Child-Pugh class A liver function
- ECOG 0-1
- Signed informed consent
Who cannot join
- Prior systemic HCC therapy within 6 months
- Main portal vein tumor thrombosis (VP4)
- Active autoimmune disease requiring immunosuppression
- HIV/HBV/HCV with uncontrolled viral replication
- Pregnancy or refusal of contraception
About this study
This study aims to identify early predictors for successful liver cancer treatment conversion. We will track changes in immune cells (CD8+ T-cells) in the blood during chemotherapy infusion (HAIC/TACE) combined with targeted-immunotherapy for 120 patients with unresectable liver cancer. By analyzing blood and tissue samples at multiple timepoints using advanced cell profiling and multi-omics sequencing, we seek to:
Determine if early immune cell changes predict tumor shrinkage; Identify tissue biomarkers linked to longer recurrence-free survival; Build a personalized prediction model for treatment outcomes.
- Conditions
- HCC - Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Proportion of patients achieving tumor shrinkage (≥30% diameter reduction) or complete disappearance on CT/MRI scans, evaluated by RECIST v1.1 criteria. Complete response = 0 visible tumor; Partial response = ≥30% reduction in total tumor size.
Measured: From treatment initiation to 12 weeks after first therapy cycle.
Secondary outcomes (2)
Recurrence-Free Survival (RFS)
Time from successful tumor removal surgery to either: (a) new tumor growth on scans, or (b) death from any cause. Verified by quarterly CT/MRI + AFP testing.
Measured: From surgery date to first recurrence or death (assessed monthly for 24 months).
Severe Treatment-Related Side Effects
Number of patients experiencing grade ≥3 adverse events (e.g., liver damage, low blood counts) confirmed by lab tests and physician evaluation, using CTCAE v5.0 grading.
Measured: From first treatment dose to 30 days after final dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Bi Xiang, MD, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117279
- Sponsor's protocol ID
- TJ-IRB202506074
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study on Dynamic CD8+ T-cell Profiling and Multi-omics Biomarkers for Predicting Conversion Therapy Response in Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07117279
- Acronym / sponsor ID
- TJ-IRB202506074
- Conditions
- HCC - Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 12 Aug 2025 (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.
This study aims to identify early predictors for successful liver cancer treatment conversion. We will track changes in immune cells (CD8+ T-cells) in the blood during chemotherapy infusion (HAIC/TACE) combined with targeted-immunotherapy for 120 patients with unresectable liver cancer. By analyzing blood and tissue samples at multiple timepoints using advanced cell profiling and multi-omics sequencing, we seek to:
Determine if early immune cell changes predict tumor shrinkage; Identify tissue biomarkers linked to longer recurrence-free survival; Build a personalized prediction model for treatment outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with unresectable liver cancer (HCC) who are scheduled to receive HAIC/TACE plus immunotherapy at major hospitals in Shanghai. All participants must have preserved liver function (Child-Pugh A) and at least one measurable tumor. Key requirements include willingness to undergo tumor biopsy before treatment and provide repeated blood samples during therapy. Expected recruitment sources: 1) Liver cancer specialty clinics (majority), 2) Interventional radiology units.
Key inclusion criteria (6 listed)
- Adults (18-75 years) with histologically confirmed HCC
- At least one measurable lesion ≥10 mm
- Planned HAIC/TACE + immunotherapy regimen
- Child-Pugh class A liver function
- ECOG 0-1
Key exclusion criteria (5 listed)
- Prior systemic HCC therapy within 6 months
- Main portal vein tumor thrombosis (VP4)
- Active autoimmune disease requiring immunosuppression
- HIV/HBV/HCV with uncontrolled viral replication
- Pregnancy or refusal of contraception
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
Objective Response Rate (ORR)
Time frame: From treatment initiation to 12 weeks after first therapy cycle.
Proportion of patients achieving tumor shrinkage (≥30% diameter reduction) or complete disappearance on CT/MRI scans, evaluated by RECIST v1.1 criteria. Complete response = 0 visible tumor; Partial response = ≥30% reduction in total tumor size.
2 secondary outcomes
Recurrence-Free Survival (RFS)
Time frame: From surgery date to first recurrence or death (assessed monthly for 24 months).
Severe Treatment-Related Side Effects
Time frame: From first treatment dose to 30 days after final dose.
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 12 Aug 2025.
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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.
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 HCC - Hepatocellular Carcinoma, run by Tongji 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 6 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: opening soon, as of the sponsor's last update on 12 Aug 2025. 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?
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?
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?
Objective Response Rate (ORR) (time frame: From treatment initiation to 12 weeks after first therapy cycle.). 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 12 Aug 2025.