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RecruitingNCT07459309Updated Jul 8, 2026

Clinical Study on the Safety, Efficacy, and Exploration of Immune Mechanisms of a Combined Multimodal Tumor Therapy System for Hepatic Malignancies

An interventional study of Multimodal Tumor Thermal Ablation in Liver Cancer (Primary and Metastatic) and Liver Ablation, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by Fudan University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Clinical Study on the Safety, Efficacy, and Exploration of Immune Mechanisms of a Combined Multimodal Tumor Therapy System for Hepatic Malignancies

02

Conditions studied

  • Liver Cancer (Primary and Metastatic)
  • Liver Ablation
03

In context

Liver Neoplasms

1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

This study's planned enrollment of 20 is below the median of 47 across 968 interventional studies indexed under Liver Neoplasms.

Browse Liver Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18-80 years, regardless of gender;
  2. Histopathologically confirmed or clinically diagnosed hepatic malignancies, including primary liver cancer and metastatic liver cancer;
  3. Presence of an image-evaluable target lesion for ablation, with the maximum diameter of the target lesion being 3-5 cm;
  4. Patient is intolerant to or refuses surgical resection;
  5. ECOG performance status score ≤ 2, with an expected survival period of greater than 3 months.

Exclusion criteria

Exclusion Criteria:

  1. Liver function classified as Child-Pugh C, unimprovable with hepatoprotective therapy;
  2. Massive or diffuse hepatocellular carcinoma;
  3. Presence of vascular tumor thrombus or invasion of adjacent organs;
  4. History of esophageal (gastric fundus) variceal rupture and bleeding within 1 month prior to treatment;
  5. Uncorrectable coagulation dysfunction and severe hematological abnormalities, with a high risk of severe bleeding;
  6. Refractory massive ascites, cachexia;
  7. Active infection, especially inflammatory conditions of the biliary system;
  8. Severe functional failure of major organs such as liver, kidney, heart, lung, and brain;
  9. Impaired consciousness, or inability to cooperate with treatment;
  10. Previous systemic treatments (e.g., chemotherapy) with an interval of less than 2 weeks and not having recovered from prior treatment: CTCAE 6.0 grade >1 (except for alopecia);
  11. Any other factors deemed by the investigator to make the subject unsuitable for participation or to affect the subject's involvement in the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Treatment Group

    Multimodal Tumor Thermal Ablation

    Device: Multimodal Tumor Thermal Ablation

Interventions

  • DeviceMultimodal Tumor Thermal Ablation

    Multimodal Tumor Thermal Ablation

06

What researchers measure

Primary outcomes

  1. Ablation efficacy rate at 1 month postoperatively

    Ablation efficacy rate at 1 month postoperatively

    Time frame: 1 month after ablation

Secondary outcomes

  1. Changes in the Peripheral Blood Immune Microenvironment Before and After Treatment

    Changes in the Peripheral Blood Immune Microenvironment Before and After Treatment

    Time frame: 1 month after ablation

  2. Adverse events and serious adverse events

    Adverse events and serious adverse events

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai Municipality 200000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07459309
Lead sponsor
Fudan University
Responsible party
Wen-Tao Li (Director of Interventional Therapy Department,Fudan University, Fudan University) — Principal investigator
First posted
Mar 9, 2026
Start date
Apr 13, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jul 8, 2026

Study contacts

wentao li
Contact
liwentao98@126.com
+86 13774225887

Oversight

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

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