NCT03067493: RAMEC

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

Status unknown Phase 2 Last updated 26 January 2022

What this trial tests

Phase 2 trial testing Neo-MASCT in Primary Liver Cancer in 98 participants. Status unknown.

Timeline

25 July 2017

Primary endpoint
31 March 2023

31 March 2023

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	98
Start date	25 July 2017
Primary completion	31 March 2023
Estimated completion	31 March 2023
Sites	1 location across China

Drugs / interventions tested

• Neo-MASCT — full drug profile →

Conditions studied

• Primary Liver Cancer — all drugs for Primary Liver Cancer →
• Radiofrequency Ablation — all drugs for Radiofrequency Ablation →
• Immunotherapy — all drugs for Immunotherapy →
• Hepatectomy — all drugs for Hepatectomy →

Sponsor

Sun Yat-sen University

Who can join

18 and older, any sex, with Primary Liver Cancer or Radiofrequency Ablation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hepatocellular Carcinoma Immune Landscape and the Potential of Immunotherapies.
   Giraud J, Chalopin D, Blanc JF, Saleh M. · · 2021 · cited 172× · PMID 33815418 · DOI 10.3389/fimmu.2021.655697
2. Immunosuppressive tumor microenvironment and immunotherapy of hepatocellular carcinoma: current status and prospectives.
   Shen KY, Zhu Y, Xie SZ, Qin LX. · · 2024 · cited 140× · PMID 38679698 · DOI 10.1186/s13045-024-01549-2
3. Combination Neoantigen-Based Dendritic Cell Vaccination and Adoptive T-Cell Transfer Induces Antitumor Responses Against Recurrence of Hepatocellular Carcinoma.
   Peng S, Chen S, Hu W, Mei J, et al · · 2022 · cited 56× · PMID 35476700 · DOI 10.1158/2326-6066.cir-21-0931
4. Trial Watch: Adoptively transferred cells for anticancer immunotherapy.
   Fournier C, Martin F, Zitvogel L, Kroemer G, et al · · 2017 · cited 55× · PMID 29147628 · DOI 10.1080/2162402x.2017.1363139
5. Dendritic-Cell-Vaccine-Based Immunotherapy for Hepatocellular Carcinoma: Clinical Trials and Recent Preclinical Studies.
   Jeng LB, Liao LY, Shih FY, Teng CF. · · 2022 · cited 31× · PMID 36139542 · DOI 10.3390/cancers14184380
6. Dendritic cell subsets and implications for cancer immunotherapy.
   Chen MY, Zhang F, Goedegebuure SP, Gillanders WE. · · 2024 · cited 24× · PMID 38903502 · DOI 10.3389/fimmu.2024.1393451
7. Research Progress on Dendritic Cells in Hepatocellular Carcinoma Immune Microenvironments.
   Li W, Chen G, Peng H, Zhang Q, et al · · 2024 · cited 17× · PMID 39334927 · DOI 10.3390/biom14091161
8. Clinical application status and prospect of the combined anti-tumor strategy of ablation and immunotherapy.
   Yin L, Li XY, Zhu LL, Chen GL, et al · · 2022 · cited 15× · PMID 36131929 · DOI 10.3389/fimmu.2022.965120