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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
| Ruijin Hospital | OTHER |
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Multimodal thermal therapy (MTT), as an initiative integration of cryotherapy and radiofrequency heating, has been applied to treat various solid tumors. The feasibility and safety for MTT in the treatment of malignant liver tumors is well-established. This prospective, multi-center, randomized controlled clinical study aimed to explore the ablation-induced immune activating response of MTT in the treatment of malignant liver tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal Tumor Thermal Therapy | Experimental | These patients will receive multimodal thermal therapy using multimodal tumor thermal therapy system. |
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| Single Thermal Ablation | Experimental | These patients will receive local ablation using the microwave ablation system or radiofrequency ablation system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal Tumor Thermal Therapy System | Device | All subjects were treated with a multi-modal thermal therapy system (Shanghai MAaGI Medical Technology Co., Ltd.) following a temperature-controlled tumor ablation protocol. Complete ablation of intrahepatic lesions was achieved, resulting in no evidence of disease (NED) within the liver. For lesions that could not be fully ablated in a single session, two treatment sessions were performed to attain intrahepatic NED status. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS was defined as the time from the first ablation until local tumor progression, any identification of a new (nontarget) lesion/tumor during follow-up, or death due to any cause (whichever occurs first). | At 12 months after the ablation procedure on Day 0 |
| Assessment of immune activating response | The landscape of the peripheral immune response induced by local ablation in patients with malignant liver tumors. | In 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate（ORR） | Refers to the proportion of patients whose tumors shrink to a certain extent and maintain that response for a specified period, including cases of Complete Response (CR) and Partial Response (PR). Tumor objective response is assessed using mRECIST criteria. At baseline, subjects must have measurable tumor lesions. According to the efficacy evaluation criteria, the outcomes are classified as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD). |
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Inclusion Criteria:
(1) Blood Routine: WBC≥3.0×109/L，ANC≥1.5×109/L，PLT≥50×109/L，HGB≥90 g/L. (2) Liver Function: AST ≤5.0×ULN, ALT ≤5.0×ULN, TBIL ≤2.0×ULN. (3) Renal Function: Cr ≤1.5×ULN or CrCl ≥60 mL/min. (4) Coagulation Function: INR ≤1.5; APTT ≤1.5×ULN. (5) HBV-DNA: HBV-DNA ≤2×10³ IU/mL (*Patients with HBV-DNA >2×10³ IU/mL may be enrolled but must receive antiviral therapy.*)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lichao Xu, M.D | Contact | : +86-021-64175590 | lichaoxu163@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lichao Xu, M.D | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
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| Radiofrequency Ablation System or Microwave Ablation System | Device | All subjects were treated with a radiofrequency ablation system or microwave ablation System. Complete ablation of intrahepatic lesions was achieved, resulting in no evidence of disease (NED) within the liver. For lesions that could not be fully ablated in a single session, two treatment sessions were performed to attain intrahepatic NED status. |
|
| At 6 months after the ablation procedure on Day 0 |
| Local Control Rate（LCR） | LCR is defined as the proportion of patients demonstrating absence of disease progression at the ablated target site according to mRECIST criteria, as evaluated by diagnostic imaging, without evidence of progressive disease (PD) within the prescribed follow-up period. | At 6 months after the ablation procedure on Day 0 |
| Overall Survival (OS) | OS refers to the time from the date of enrollment to the date of death due to any cause. | At 36 months after the ablation procedure on Day 0 |
| Percentage of Participants With Adverse Events (AEs) Within 3 Months Post Ablation | Percentage of participants with AEs within 3 months post ablation were reported. An AE was an untoward medical occurrence (sign, symptom or disease) in a participant, and which did not necessarily have a causal relationship with the study medical device. | From time of first ablation (Day 0) up to 3 months post ablation |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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