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AzTrials

Liver CancerPhase 4RFANCT04707547

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

A Phase 4 study testing immunotherapy with Nivolumab and Radiofrequency Ablation in people with Liver Cancer, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Liver Cancer
What is being tested?
immunotherapy with Nivolumab and Radiofrequency Ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5 participants
Where
1 siteTaiwan
Study dates
16 Oct 2019to 23 Jul 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Wanfang Hospital

    Taipei, Wenshan District, 116

Other trials in Taiwan

About this study

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.

Read the 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.

Conditions
Liver Cancer
Being tested
immunotherapy with Nivolumab, Radiofrequency Ablation
Keywords
immune cells
Medical subject headings
Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • immunotherapy with NivolumabBiological

    After subjects had received radiofrequency ablation for two weeks, they were performed by immunotherapy with Nivolumab 200mg.

  • Radiofrequency AblationProcedure or surgery

    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 groups in NCT04707547
Study groupRoleWhat they receive
Radiofrequency AblationExperimentalMalignant Liver Tumors With Radiofrequency Ablation (RFA) Therapy
Receives: Procedure: Radiofrequency Ablation
Radiofrequency Ablation combine with NivolumabPlacebo comparatorMalignant Liver Tumors With Radiofrequency Ablation (RFA) Therapy, and improving immune systems by Nivolumab
Receives: Biological: immunotherapy with Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2021
  2. Study start16 Oct 2019
  3. Primary completion23 Jul 2020
  4. Study completion23 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04707547
Sponsor's protocol ID
N201812053
Acronym
RFA
Status last verified
Dec 2020
First submitted
16 Dec 2020
Last updated
13 Jan 2021
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19251937

  • 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.

    PubMed 23825037

  • 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.

    PubMed 18202772

  • 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.

    PubMed 28397821

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing immunotherapy with Nivolumab and Radiofrequency Ablation in people with Liver Cancer, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Analysis of the number of CD8+ T (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04707547, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.

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