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

  • STATUS
    Recruiting
  • End date
    Mar 31, 2023
  • participants needed
    98
  • sponsor
    Sun Yat-sen University
Updated on 23 March 2022
platelet count
renal function
total bilirubin
prothrombin
metastasis
neutrophil count
neo-masct

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.

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.

Details
Condition Primary Liver Cancer, Radiofrequency Ablation, Immunotherapy, Hepatectomy
Treatment Neo-MASCT
Clinical Study IdentifierNCT03067493
SponsorSun Yat-sen University
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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