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A Prospective, Multi-center, Randomized Controlled Clinical Trial to Evaluate the Safety, Efficacy and Immune Response of Multimodal Thermal Therapy in the Treatment of Malignant Liver Tumors

A Prospective, Multi-center, Randomized Controlled Clinical Trial to Evaluate the Safety, Efficacy and Immune Response of Multimodal Thermal Therapy in the Treatment of Malignant Liver Tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107845
Enrollment
Unknown
Registered
2025-08-20
Start date
2025-08-25
Completion date
Unknown
Last updated
2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical diagnosis or pathologic of hepatocellular carcinoma (HCC) or metastatic liver cancers

Interventions

Trial group:Multimodal Thermal Therapy
Control group:Radiofrequency ablation or microwave ablation therapy

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age of 18-75 years. 2. Clinical diagnosis or pathologic of hepatocellular carcinoma (HCC) or metastatic liver cancers. 3. Intrahepatic lesions with a diameter of =3.0×10^9/L,ANC>=1.5×10^9/L,PLT>=50×10^9/L,HGB>=90 g/L; (2) Liver Function: AST =60 mL/min (4) Coagulation Function: INR 2×10³ IU/mL may be enrolled but must receive antiviral therapy.*)

Exclusion criteria

Exclusion criteria: 1. Diffuse hepatocellular carcinoma (HCC), or with tumor thrombus in the main portal vein to secondary branches or hepatic veins. 2. Severe liver atrophy or excessively large tumor volume requiring ablation of =1/3 of the liver volume. 3. Uncorrectable coagulation dysfunction or severe hematologic abnormalities with a high risk of bleeding. 4. Active bacterial infection or fungal infection. 5. Previous or coexisting malignancies. 6. History of solid organ transplant or hepatic encephalopathy. 7. Current enrollment in another clinical trial or prior exposure to experimental therapies 8. Pregnant or breastfeeding, or preparing to pregnant. 9. Not suitable to participate in clinical trials judged by investigator.

Design outcomes

Primary

MeasureTime frame
Assessment of immune activating response;Progression Free Survival (PFS);Percentage of Participants With Adverse Events (AEs);

Secondary

MeasureTime frame
Objective Response Rate(ORR);Local Control Rate(LCR);

Countries

China

Contacts

Public ContactLichao Xu

Fudan University Shanghai Cancer Center

lichaoxu163@163.com+86 21 6417 5590

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026