Combined multimodal tumor therapy system for liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study tests a multimodal tumor therapy system that uses thermal ablation to target liver tumors and explores potential immune mechanisms. Eligible participants are adults 18-80 with hepatic malignancies and a measurable lesion suitable for ablation who are not candidates for surgical resection and have a reasonable performance status. The study will assess safety and efficacy, with attention to how the treatment interacts with the immune system. Key criteria exclude those with advanced liver dysfunction, extensive disease, vascular invasion, recent variceal bleeding, or uncorrectable coagulation issues. The trial is led by Fudan University at the Shanghai Cancer Center, with no listed collaborators.

Why it matters

Who can join: the full rules

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:

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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: wentao li
• Email: liwentao98@126.com
• Phone: +86 13774225887

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.