NCT03175705

Adoptive Transfer of Specific HCC Antigens CD8+ T Cells for Treating Patients With Relapsed/Advanced HCC

Status unknown Phase 1 Last updated 18 January 2018

What this trial tests

Phase 1 trial testing HCC antigens-specific CD8+ T lymphocytes in Hepatocellular Carcinoma in 18 participants. Status unknown.

Timeline

1 May 2017

Primary endpoint
30 December 2018

30 March 2019

Quick facts

Lead sponsor	Beijing YouAn Hospital
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	1 May 2017
Primary completion	30 December 2018
Estimated completion	30 March 2019
Sites	1 location across China

Drugs / interventions tested

• HCC antigens-specific CD8+ T lymphocytes — full drug profile →
• IL-2 — full drug profile →
• Tegafur (TEGAFUR) — full drug profile →

Conditions studied

• Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →

Sponsor

Beijing YouAn Hospital

Who can join

Adults 18 to 80, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study enrolls patients who have relapsed/advanced hepatocellular carcinoma (HCC, BCLC stage C). The HCC tumor relapsed or metastasized through the body after standard treatment or the patients cannot receive standard treatment under current conditions. This research study uses specific HCC antigens CD8+ T cells, a new experimental treatment.

The purpose of this study is to evaluate the safety and tolerance as well as the potential clinical efficacy of an adoptive transfer of CD8+ T cells, sorted with human leukocyte antigen (HLA)-peptide multimers and specific for Glypican (GPC)-3 /New York Esophageal Squamous-1 (NY-ESO-1) /alpha-fetoprotein (AFP) antigens and cultured in vitro, to patients suffering from relapsed/advanced hepatocellular carcinoma (HCC).

Publications & conference data

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

1. NY-ESO-1 Based Immunotherapy of Cancer: Current Perspectives.
   Thomas R, Al-Khadairi G, Roelands J, Hendrickx W, et al · · 2018 · cited 298× · PMID 29770138 · DOI 10.3389/fimmu.2018.00947
2. Molecular and immune landscape of hepatocellular carcinoma to guide therapeutic decision-making.
   Dhanasekaran R, Suzuki H, Lemaitre L, Kubota N, et al · · 2025 · cited 42× · PMID 37300379 · DOI 10.1097/hep.0000000000000513
3. The promise of adoptive cellular immunotherapies in hepatocellular carcinoma.
   Hendrickson PG, Olson M, Luetkens T, Weston S, et al · · 2020 · cited 34× · PMID 32002284 · DOI 10.1080/2162402x.2019.1673129
4. Immuno-Oncotherapeutic Approaches in Advanced Hepatocellular Carcinoma.
   Park R, Eshrat F, Al-Jumayli M, Saeed A, et al · · 2020 · cited 19× · PMID 32784389 · DOI 10.3390/vaccines8030447
5. New Therapeutics for HCC: Does Tumor Immune Microenvironment Matter?
   Khanam A, Kottilil S. · · 2022 · cited 17× · PMID 36613878 · DOI 10.3390/ijms24010437
6. Engineering T cells for immunotherapy of primary human hepatocellular carcinoma.
   Caraballo Galva LD, Cai L, Shao Y, He Y. · · 2020 · cited 12× · PMID 32089500 · DOI 10.1016/j.jgg.2020.01.002
7. Targeting Glypican-3 for Liver Cancer Therapy: Clinical Applications and Detection Methods.
   Zhang J, Li R, Tan X, Wang C. · · 2025 · cited 9× · PMID 40862283 · DOI 10.14218/jcth.2025.00099
8. Targeting HPV in gynaecological cancers - Current status, ongoing challenges and future directions.
   Crusz SM, El-Shakankery K, Miller RE. · · 2020 · cited 8× · PMID 33296284 · DOI 10.1177/1745506520961709