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

Phase 4

Completed

• Conditions: Liver Cancer
• Interventions: Biological: immunotherapy with Nivolumab; Procedure: Radiofrequency Ablation

• Registration Number: NCT04707547
• Lead Sponsor: Taipei Medical University WanFang Hospital

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 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.

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 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.

Study Timeline

• Study Start: 2019-10-16
• Primary Completion: 2020-07-23
• Study Completion: 2020-07-23
• Status Verified: 2020-12
• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2021-01-12
• Last Update Submitted: 2021-01-12
• Study First Posted: 2021-01-13
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiofrequency Ablation combine with Nivolumab	immunotherapy with Nivolumab	Malignant Liver Tumors With Radiofrequency Ablation (RFA) Therapy, and improving immune systems by Nivolumab
Radiofrequency Ablation	Radiofrequency Ablation	Malignant Liver Tumors With Radiofrequency Ablation (RFA) Therapy

Primary Outcome Measures

Name	Time	Method
Analysis of the number of CD8+ T	6 weeks	Analysis of the number of CD8+ T Using PBMC to analyze the number of CD8+ T that is NK, NKT, DC, and Monocyte. Four-time blood draws - 15 ml/each. Week 0- the data of CD8+T before RFA. Week 1- the data of CD8+T after RFA. Week 3- the data of CD8+T after participators received the vaccine which is Nivolumab 200mg in Week 2.; Week 6- the data of CD8+T; Compare with Week 0 and Week 1 data for analysis the difference of the ability of the immune system.; Compare with Week 1 and Week 3 data, if week 3 data is higher than week 1, it means that immunotherapy with Nivolumab has effects to strengthen the immune system.; Compare with Week 3 and Week 6 for analysis the effects of immunotherapy with Nivolumab have continued or not.; Moreover, analyzed the difference in the immune system between participators who received the vaccine and no received vaccine from week 3 to week 6.

Trial Locations

Locations (1)

Wanfang Hospital; 🇨🇳 Taipei, Wenshan District, Taiwan