Immune Profile and Prognosis of Malignant Liver Tumors With Radiofrequency Ablation (RFA) Therapy

Sponsor
Taipei Medical University WanFang Hospital
Study ID
NCT04707547
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • immunotherapy with Nivolumab — BIOLOGICAL
    After subjects had received radiofrequency ablation for two weeks, they were performed by immunotherapy with Nivolumab 200mg.
  • Radiofrequency Ablation — PROCEDURE
    The most commonly used local ablation is radiofrequency ablation. In this operation, a radio frequency probe is used to insert the liver cancer under ultrasound or computer tomography guidance, and then the radio frequency waves generated by the current oscillations locally heat the high temperature, causing the liver cancer cells to die.

Study Details

Clearing potential intrahepatic metastasis to prevent early recurrence after liver cancer treatment, there are no effective interventions so far. For secondary metastatic cancer, only the lesions visible under ultrasound can be used, one by one for local ablation and chemotherapy, but people may develop new tumor lesions. Therefore, the treatment of potential tumors and recurrent tumors after ablation is a very important clinical issue.

Key Dates

Start date
Oct 16, 2019
Status verified
Dec 2020
Primary completion
Jul 23, 2020
Completion
Jul 23, 2020

Study Design

Enrollment
5 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Radiofrequency Ablation
    Malignant Liver Tumors With Radiofrequency Ablation (RFA) Therapy
  • Placebo Comparator: Radiofrequency Ablation combine with Nivolumab
    Malignant Liver Tumors With Radiofrequency Ablation (RFA) Therapy, and improving immune systems by Nivolumab

Primary Outcome Measure

Analysis of the number of CD8+ T [ Time Frame: 6 weeks ]

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