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Status:

COMPLETED

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

Lead Sponsor:

Taipei Medical University WanFang Hospital

Conditions:

Liver Cancer

Eligibility:

All Genders

20+ years

Phase:

PHASE4

Brief Summary

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 visi...

Detailed Description

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 visi...

Eligibility Criteria

Inclusion

  • Disease characteristics: Patients with primary or metastatic liver cancer judged by histology
  • Age: 20 years old or older
  • Life expectation: at least 3 months
  • Hematology:
  • Platelet count: at least 50,000/mm\^3
  • Prothrombin time (PT) or partial thromboplastin time (PTT): no more than 1.5 times the control group
  • Creatinine: no more than 2.5 mg/dl
  • No pregnancy, no rhythm adjuster or other implantable device
  • There are no uncontrollable responses to this study
  • Other malignant tumors, except for therapeutic non-melanoma skin cancer or cervical cancer 5 years before entering the study inside.
  • The number of liver tumors is less than three, the size is less than three centimeters, or the size of a single tumor is less than five centimeters, and those who want to undergo radiofrequency ablation are treated.
  • The clotting time is normal and the number of platelets needs to be greater than 50,000, total bilirubin is less than 3 mg/dl, controllable ascites, no extrahepatic metastasis and portal vein invasion, and those who want to undergo radiofrequency ablation.
  • The patient refuses or is unable to perform surgery (eg, If the age is too old, for those who want to undergo radiofrequency ablation).
  • Patients and their families must fully understand and agree to perform radiofrequency ablation procedures.

Exclusion

  • There are people with central nervous system metastases.
  • Measure lesions only by previous radiotherapy or topical treatment.
  • Biliary obstruction did not undergo adequate drainage procedures prior to enrollment.
  • White blood cells (WBC) are less than 3,500 / mm3 and absolute neutrophil count (ANC) is less than 1,500 / mm3, platelets less than 100,000 / mm3
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is greater than 5.0 times the upper limit of the normal range (ULN).
  • Serum total bilirubin levels are equal to or greater than 2.0 mg / dl.
  • Serum creatinine greater than 1.5 mg / dl.
  • There are peripheral neuropathies greater than grade 1.
  • Concomitant diseases that may accumulate via chemotherapy. For example, active, noncontrolled infection or other activity, non-control Systemic diseases such as congestive heart failure, angina pectoris, respiratory insufficiency, arrhythmia.
  • Those who are treated concurrently with other research drugs or other anti-cancer therapies.
  • Pregnant or lactating women, or women with fertility potential, unless reliable and appropriate methods of contraception are used.

Key Trial Info

Start Date :

October 16 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 23 2020

Estimated Enrollment :

5 Patients enrolled

Trial Details

Trial ID

NCT04707547

Start Date

October 16 2019

End Date

July 23 2020

Last Update

January 13 2021

Active Locations (1)

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Wanfang Hospital

Taipei, Wenshan District, Taiwan, 116