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

Primary Purpose

Liver Cancer

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
immunotherapy with Nivolumab
Radiofrequency Ablation
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring immune cells

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Wanfang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Radiofrequency Ablation

Radiofrequency Ablation combine with Nivolumab

Arm Description

Malignant Liver Tumors With Radiofrequency Ablation (RFA) Therapy

Malignant Liver Tumors With Radiofrequency Ablation (RFA) Therapy, and improving immune systems by Nivolumab

Outcomes

Primary Outcome Measures

Analysis of the number of CD8+ T
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.

Secondary Outcome Measures

Full Information

First Posted
December 16, 2020
Last Updated
January 12, 2021
Sponsor
Taipei Medical University WanFang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04707547
Brief Title
Immune Profile and Prognosis of Malignant Liver Tumors With Radiofrequency Ablation (RFA) Therapy
Acronym
RFA
Official Title
Immune Profile and Prognosis of Malignant Liver Tumors With Radiofrequency Ablation (RFA) Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 16, 2019 (Actual)
Primary Completion Date
July 23, 2020 (Actual)
Study Completion Date
July 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University WanFang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
immune cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiofrequency Ablation
Arm Type
Experimental
Arm Description
Malignant Liver Tumors With Radiofrequency Ablation (RFA) Therapy
Arm Title
Radiofrequency Ablation combine with Nivolumab
Arm Type
Placebo Comparator
Arm Description
Malignant Liver Tumors With Radiofrequency Ablation (RFA) Therapy, and improving immune systems by Nivolumab
Intervention Type
Biological
Intervention Name(s)
immunotherapy with Nivolumab
Intervention Description
After subjects had received radiofrequency ablation for two weeks, they were performed by immunotherapy with Nivolumab 200mg.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency Ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Analysis of the number of CD8+ T
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Shun Wu, PHD
Organizational Affiliation
Taipei Municipal Wanfang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Wanfang Hospital
City
Taipei
State/Province
Wenshan District
ZIP/Postal Code
116
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19251937
Citation
Dromi SA, Walsh MP, Herby S, Traughber B, Xie J, Sharma KV, Sekhar KP, Luk A, Liewehr DJ, Dreher MR, Fry TJ, Wood BJ. Radiofrequency ablation induces antigen-presenting cell infiltration and amplification of weak tumor-induced immunity. Radiology. 2009 Apr;251(1):58-66. doi: 10.1148/radiol.2511072175. Epub 2009 Feb 27.
Results Reference
background
PubMed Identifier
23825037
Citation
Cui J, Wang N, Zhao H, Jin H, Wang G, Niu C, Terunuma H, He H, Li W. Combination of radiofrequency ablation and sequential cellular immunotherapy improves progression-free survival for patients with hepatocellular carcinoma. Int J Cancer. 2014 Jan 15;134(2):342-51. doi: 10.1002/ijc.28372. Epub 2013 Aug 5.
Results Reference
background
PubMed Identifier
18202772
Citation
Napoletano C, Taurino F, Biffoni M, De Majo A, Coscarella G, Bellati F, Rahimi H, Pauselli S, Pellicciotta I, Burchell JM, Gaspari LA, Ercoli L, Rossi P, Rughetti A. RFA strongly modulates the immune system and anti-tumor immune responses in metastatic liver patients. Int J Oncol. 2008 Feb;32(2):481-90.
Results Reference
background
PubMed Identifier
28397821
Citation
Huang AC, Postow MA, Orlowski RJ, Mick R, Bengsch B, Manne S, Xu W, Harmon S, Giles JR, Wenz B, Adamow M, Kuk D, Panageas KS, Carrera C, Wong P, Quagliarello F, Wubbenhorst B, D'Andrea K, Pauken KE, Herati RS, Staupe RP, Schenkel JM, McGettigan S, Kothari S, George SM, Vonderheide RH, Amaravadi RK, Karakousis GC, Schuchter LM, Xu X, Nathanson KL, Wolchok JD, Gangadhar TC, Wherry EJ. T-cell invigoration to tumour burden ratio associated with anti-PD-1 response. Nature. 2017 May 4;545(7652):60-65. doi: 10.1038/nature22079. Epub 2017 Apr 10.
Results Reference
background

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

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