NCT03067493

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Primary Liver Cancer
• Radiofrequency Ablation
• Immunotherapy
• Hepatectomy

Interventions

Type	Name	Description
BIOLOGICAL	Neo-MASCT	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.

Timeline

• Start date: 2017-07-25
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2017-03-01
• Last updated: 2022-01-26

Locations

1 site across 1 country: China