ClinicalTrials.gg
Not yet recruitingNCT07937137Updated Nov 13, 2026

Liver Tumor Microenvironment Remodeling Promotes Hepatocellular Carcinoma Progression

An observational study in Liver Cancer (Primary and Metastatic), sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine. Not yet recruiting. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Observational

Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Hepatocellular carcinoma (HCC) is a highly prevalent malignancy worldwide. Although radiofrequency ablation (RFA) is widely used for the treatment of early-stage small HCC, its 5-year recurrence rate reaches up to 70%, significantly higher than that of surgical resection, suggesting that the tumor microenvironment (TME) plays a critical role in the progression of residual tumors. Notably, in the context of non-alcoholic fatty liver disease (NAFLD), HCC patients with concurrent fatty liver have an even higher risk of post-RFA recurrence and metastasis, yet the underlying mechanisms remain unclear. Recent studies have shown that extracellular vesicles (EVs), as important mediators of intercellular communication, are abundantly released in the fatty liver microenvironment. By carrying bioactive molecules such as proteins and nucleic acids, EVs remodel the TME and promote HCC cell proliferation, migration, and immune evasion. However, how fatty liver-derived EVs specifically regulate the malignant progression of residual tumors and reshape the immune and metabolic microenvironment under conditions of local thermal stress and ischemia-hypoxia following RFA remains poorly understood. Based on these findings, this project proposes the scientific hypothesis that abnormally released EVs in the fatty liver microenvironment promote post-RFA tumor progression by remodeling the TME and inducing residual HCC cells to acquire a more aggressive phenotype. Elucidating this mechanism is of great significance for understanding the causes of high post-RFA recurrence in the context of fatty liver, identifying potential biomarkers, and developing novel adjuvant therapeutic strategies.

02

Conditions studied

  • Liver Cancer (Primary and Metastatic)
03

In context

Liver Neoplasms

1,346 studies on the registry are indexed under Liver Neoplasms; 334 are open to participants now.

This study's planned enrollment of 30 is below the median of 200 across 342 observational studies indexed under Liver Neoplasms.

Browse Liver Neoplasms studies →

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine is the lead sponsor of 96 studies on the registry; 82 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Clinical data of patients undergoing radiofrequency ablation of liver cancer in the Fourth Affiliated Hospital of Zhejiang University were collected

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

HCC Patient Inclusion Criteria:

Patients with hepatocellular carcinoma (HCC) who meet the following criteria were included: solitary tumor diameter ≤ 5 cm; for multiple tumors, no more than 3 lesions with each tumor diameter ≤ 3 cm, and no evidence of extrahepatic ; class A or B; absence of ascites or uncorrectable coagulation dysfunction; prothrombin activity > 40% and count > 500,000/L.

Fatty Liver Disease Inclusion Criteria:

Patients were diagnosed with fatty liver disease based on the following criteria: imaging evidence of fatty liver and/or liver demonstrating ≥5% macrovesicular steatosis of hepatocytes; presence of one or more components of metabolic syndrome; and exclusion of other potential causes of fatty liver, including excessive alcohol consumption, malnutrition, and Wilson's disease.

Exclusion criteria

Exclusion Criteria:

HCC Patient Exclusion Criteria:

Patients were excluded if they presented with vascular invasion or extrahepatic , severe coagulation disorders, severe cardiopulmonary insufficiency, or uncontrolled hepatic decompensation.

Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
30 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • treatment after RFA
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What researchers measure

Primary outcomes

  1. progression-free survival

    Time frame: 1 years after RFA traeatment

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2030, 48 months later.

Of 132 non-industry observational studies under Liver Neoplasms, half reached primary completion within 114 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 172. This study's planned 48 months is below that.

Counting every sponsor, half of 160 studies reached it within 59 months; a quarter within 34 and three quarters within 172.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 8, 2026
First posted
Nov 13, 2026
StartEst.
Nov 30, 2026
Primary completionEst.
Nov 30, 2030
CompletionEst.
Nov 30, 2030
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07937137
Lead sponsor
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Responsible party
Sponsor
First posted
Nov 13, 2026
Start date
Nov 30, 2026 (estimated)
Primary completion
Nov 30, 2030 (estimated)
Completion
Nov 30, 2030 (estimated)
Last update
Nov 13, 2026

Study contacts

Zhe Tang
Contact
8xi@zju.edu.cn
18867961022
Qitao Hu
Contact
22118078@zju.edu.cn
13588727974

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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