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Primary Liver CancerPhase 2RAMECNCT03067493

RFA or Surgical Resection Combined With Neo-MASCT for Primary HCC: a Phase II Trial

A Phase 2 study testing Neo-MASCT in people with Primary Liver Cancer and Radiofrequency Ablation, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RAMEC is a phase II, multi-center, randomized trial with a safety test. There will be a safety test to establish the safety and tolerability of Neo-MASCT treatment and assess the immune response to the treatment.The randomized trial will assess DFS and immune response. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Neo-MASCT
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
1 siteChina
Study dates
25 Jul 2017to 31 Mar 2023
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged ≥ 18 years;
  • Primary HCC received RFA/Hepatectomy as the initial treatment; a solitary tumour 2.0-5.0m in diameter; or 2-3 tumours with the largest ≤5.0cm; all without vascular invasion, lymphatic metastasis or distant metastasis (see Appendix 1 for diagnosis criteria).
  • ECOG 0/1 (Appendix 3);
  • Child-Pugh score 5-7 (Appendix 4);
  • A life expectancy of 6 months or more；
  • Adequate haematological, liver and renal function Neutrophil count ≥1.5 x 109/L; platelet count> 60 x 109/L; Haemoglobin concentration≥9.0 g/dL; Serum albumin≥ 3.0 g/dL; A total bilirubin of less than 1.5 times upper limit of normal; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 3 times upper limit of normal; Prothrombin time ≤3s above the control Serum creatinine concentration of 1.5 times the upper limit of the normal range or less; CCR ≥60ml/min
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  • Written informed consent
  • Imaging (enhanced CT or MRI) confirmed completely tumor necrosis or tumor removed 4 weeks after RFA/Hepatectomy；
  • Obtaining adequate samples of the matched tumor and adjacent nontumor normal liver tissues;
  • Sensitive mutations can be detected by gene sequencing in tumour tissue;
  • Prediction of neoantigen peptides ≥10;
  • Synthesized neo antigen peptides ≥5.

Who cannot join

  • Pregnant women, lactating women or women planning to be pregnant in 2 years;
  • Intrahepatic metastasis, tumour thrombosis in main trunk or main branches of portal vein, tumour thrombosis in hepatic vein;
  • Systematic use of potent immunosuppressive agents within 6 months or long-term use of them such as corticosteroids, cyclosporine A, et al;
  • Concomitant HIV or HCV infection;
  • Concomitant immunodeficiency diseases or autoimmune diseases (eg. rheumatoid arthritis, Buerger's disease, multiple sclerosis and type I diabetes);
  • Concomitant malignancy or previous malignancy within 5 years before enrolment, excluding skin cancer, local prostate cancer or cervical carcinoma in situ;
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  • Organ transplant recipients;
  • Patients with active auto-immune disorder, e.g. autoimmune hepatitis, systemic lupus erythematous etc.;
  • Severe dysfunction of the heart, kidney, or other organs;
  • Severe psychological dysfunction;
  • Sensitive to cytokines, any reagent or associated component in MASCT;
  • Ever participated in any clinical trial of other drugs within 3 months before enrolment;
  • Other patients that investigators think unsuitable to be enrolled.

Trial locations and contacts

1 site in 1 country.

Ming Kuang, Ph.D. contact

008687755766 ext. 8576

kuangm@mail.sysu.edu.cn

China1 site, 1 recruiting

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080

    Ming Kuang, Ph.D., 008687755766 ext. 8576, kuangm@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Radiofrequency Ablation or Surgical Resection Combined With Neo-MASCT for Primary Hepatocellular Carcinoma: a Randomised, Multicentre Phase II Trial

RAMEC is a phase II, multi-center, randomized trial with a safety test. There will be a safety test to establish the safety and tolerability of Neo-MASCT treatment and assess the immune response to the treatment.The randomized trial will assess DFS and immune response.

Read the detailed description

The safety test will recruit 10 patients. Following registration they will receive 3 cycles of Neo-MASCT treatment. Patients will be seen at week 1, week 2 and week 4 of every cycle.

Following the safety test, 98 patients will be randomized to the trial across 3 recruiting centers. All patients on the treatment arm will complete up to 18 cycles of Neo-MASCT treatment. Patients on the control arm will be actively monitored after randomization. Blood samples for immune response test will be taken at baseline, cycle 1day 1 and then 3 monthly on day 1 of the subsequent cycles. The planned treatment duration will be until relapse of disease, unacceptable toxicity or withdrawal of consent. The end of the trial will be 24 months after the recruitment of the last patient.

Being tested
Neo-MASCT
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • Neo-MASCTBiological

    Patients assigned to Neo-MASCT treatment will receive 18 cycles of neo-MASCT (6 courses), with one cycle every month for the first year and one cycle every 2 months for the second year. Each cycle includes one DCs subcutaneous injection and one CTLs infusion.

Study groups in NCT03067493
Study groupRoleWhat they receive
Neo-MASCT groupExperimentalPatients in the treatment group will receive a total of 6 courses of Neo-MASCT treatment. The whole period of Neo-MASCT treatment for each patient will be up to 24 months.Three stratification factors are considered, i.e.tumor size (2.1-3.0cm, 3.1-5.0cm), tumor number (1, >1) and type of surgery (RFA，hepatectomy).
Receives: Biological: Neo-MASCT
Control groupNo interventionPatients in the control group will be actively monitored during the trial period. Patients will receive assessment every 3 months in the first 3 years.

What is being measured

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

  1. Disease free survival

    Defined in whole days as the time from randomisation until disease recurrence or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and relapse free. Patients not having an event will be censored at the date last seen alive and relapse free.

    Measured: 2-year

  2. Immune response rate

    The demonstration of immune response is potentially related to prognosis and will be quantified in both groups because ablative therapy alone has been shown to induce anti-tumour immune responses.

    Measured: 2-year

Secondary outcomes (3)

  1. Overall survival

    Defined in whole days as the time from randomisation until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.

    Measured: 2-year

  2. Recurrence rate

    The rate of HCC recurrence in the total number of patients.

    Measured: 2-year

  3. Safety events

    Safety events will be measured in terms of the occurrence, severity, type and causality of Adverse Events (AEs) during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 4).

    Measured: 2-year

Timeline

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

  1. First posted1 Mar 2017
  2. Study start25 Jul 2017
  3. Primary completion31 Mar 2023 (estimated)
  4. Study completion31 Mar 2023 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
98 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03067493
Sponsor's protocol ID
HCC008
Acronym
RAMEC
Status last verified
Jan 2022
First submitted
26 Feb 2017
Last updated
26 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Peng ZW, Zhang YJ, Chen MS, Xu L, Liang HH, Lin XJ, Guo RP, Zhang YQ, Lau WY. Radiofrequency ablation with or without transcatheter arterial chemoembolization in the treatment of hepatocellular carcinoma: a prospective randomized trial. J Clin Oncol. 2013 Feb 1;31(4):426-32. doi: 10.1200/JCO.2012.42.9936. Epub 2012 Dec 26.

    PubMed 23269991

  • Ali MY, Grimm CF, Ritter M, Mohr L, Allgaier HP, Weth R, Bocher WO, Endrulat K, Blum HE, Geissler M. Activation of dendritic cells by local ablation of hepatocellular carcinoma. J Hepatol. 2005 Nov;43(5):817-22. doi: 10.1016/j.jhep.2005.04.016. Epub 2005 Jun 20.

    PubMed 16087270

  • Shi L, Chen L, Wu C, Zhu Y, Xu B, Zheng X, Sun M, Wen W, Dai X, Yang M, Lv Q, Lu B, Jiang J. PD-1 Blockade Boosts Radiofrequency Ablation-Elicited Adaptive Immune Responses against Tumor. Clin Cancer Res. 2016 Mar 1;22(5):1173-1184. doi: 10.1158/1078-0432.CCR-15-1352.

    PubMed 26933175

  • Wissniowski TT, Hansler J, Neureiter D, Frieser M, Schaber S, Esslinger B, Voll R, Strobel D, Hahn EG, Schuppan D. Activation of tumor-specific T lymphocytes by radio-frequency ablation of the VX2 hepatoma in rabbits. Cancer Res. 2003 Oct 1;63(19):6496-500.

    PubMed 14559842

  • Forner A, Llovet JM, Bruix J. Hepatocellular carcinoma. Lancet. 2012 Mar 31;379(9822):1245-55. doi: 10.1016/S0140-6736(11)61347-0. Epub 2012 Feb 20.

    PubMed 22353262

  • Peng S, Chen S, Hu W, Mei J, Zeng X, Su T, Wang W, Chen Z, Xiao H, Zhou Q, Li B, Xie Y, Hu H, He M, Han Y, Tang L, Ma Y, Li X, Zhou X, Dai Z, Liu Z, Tan J, Xu L, Li S, Shen S, Li D, Lai J, Peng B, Peng Z, Kuang M. Combination Neoantigen-Based Dendritic Cell Vaccination and Adoptive T-Cell Transfer Induces Antitumor Responses Against Recurrence of Hepatocellular Carcinoma. Cancer Immunol Res. 2022 Jun 3;10(6):728-744. doi: 10.1158/2326-6066.CIR-21-0931.

    PubMed 35476700

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neo-MASCT in people with Primary Liver Cancer and Radiofrequency Ablation, run by Sun Yat-sen University at 1 site in China.

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 12 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 26 Jan 2022. 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 China. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Ming Kuang, Ph.D. (008687755766 ext. 8576, kuangm@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease free survival (time frame: 2-year). The study lists 2 primary outcomes in all. 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 NCT03067493, which also lists 6 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 26 Jan 2022.

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