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

Taipei Medical University

Status and phase

Completed

Phase 4

Conditions

Liver Cancer

Treatments

Biological: immunotherapy with Nivolumab

Procedure: Radiofrequency Ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT04707547

N201812053

Details and patient eligibility

About

Full 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 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. Therefore, this study will include primary liver cancer, as well as secondary metastatic malignant liver cancer, such as colorectal cancer, lung cancer, breast cancer, and other cancers with a high incidence in Chinese patients, and detection of immune cells by surgery, and through various biomarkers to explore its mechanism and efficacy.

Enrollment

5 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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:
1. Platelet count: at least 50,000/mm^3
2. Prothrombin time (PT) or partial thromboplastin time (PTT): no more than 1.5 times the control group
3. 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 criteria

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.