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A prospective, multicenter, randomized, controlled, non-inferiority clinical trial for the safety and efficacy of multimode tumor ablation therapy system in the treatment of liver malignant

A prospective, multicenter, randomized, controlled, non-inferiority clinical trial for the safety and efficacy of multimode tumor ablation therapy system in the treatment of liver malignant

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042311
Enrollment
Unknown
Registered
2021-01-17
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-12-06

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

Conditions

liver malignant

Interventions

Trial group:multimode tumor ablation therapy

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years to 80 years of either gender; 2. Histologically confirmed or clinically diagnosed liver malignant tumor, including primary liver cancer and secondary liver cancer; 3. The liver lesion planning to ablation can be evaluated by imaging. No more than 5 lesions and smaller than 4.0 cm each; 4. The patient cannot tolerate or refuses to undergo surgical resection; 5. The physical status score of ECOG <= 2, and life expectancy longer than 3 months.

Exclusion criteria

Exclusion criteria: 1. Liver function classified as Child-Pugh C, or severe jaundice, especially obstructive jaundice; 2. Diffuse liver cancer; or tumor invading the main/secondary branch of portal vein; or combined with hepatic vein tumor thrombus; 3. Estimated ablation region reach to 1/3 of the liver volume caused by large tumor or significant liver atrophy. 4. Multiple systemic metastases, with an expected survival period of 1 level). 12. Any remaining factor considered not suitable for radiofrequency ablation according to the discussion of investigators.

Design outcomes

Primary

MeasureTime frame
The primary efficacy rate;

Secondary

MeasureTime frame
The rate of complications;The accuracy of ablation;The stability of system;

Countries

China

Contacts

Public ContactWang Guangzhi
guangzhiwang2000@163.com+86 13774225887

Outcome results

None listed

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