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

Immunotherapy Clinical Trial

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

Status Recruiting

Clinical 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Hepatectomy
• Immunotherapy
• Primary Liver Cancer
• Radiofrequency Ablation

• NCT number: NCT03067493
• Study type: Interventional
• Source: Sun Yat-sen University
• Contact: Ming Kuang, Ph.D.
• Phone: 008687755766
• Email: kuangm@mail.sysu.edu.cn
• Status: Recruiting
• Phase: Phase 2
• Start date: July 25, 2017
• Completion date: March 31, 2023