Clinical trial · Interventional
Adoptive Transfer of Specific HCC Antigens CD8+ T Cells for Treating Patients With Relapsed/Advanced HCC
A Study of Specific HCC Antigens CD8+ T Cells Therapy for Treating Patients With Relapsed/Advanced Hepatocellular Carcinoma (HCC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HCC antigens-specific CD8+ T lymphocytes | Biological | — | UNRESOLVED |
| IL-2 | Drug | — | UNRESOLVED |
| Tegafur | Drug | Tegafur | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous T cell therapy+Tegafur+Interleukin-2 (IL-2)
- description
- Autologous in vitro expanded HCC antigens-specific CD8+ T lymphocytes in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with relapsed/advanced HCC.
- interventionNames
- Biological: HCC antigens-specific CD8+ T lymphocytes
- Drug: IL-2
- Drug: Tegafur
Primary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events [Safety]
- timeFrame
- 4 weeks
- description
- Defined as signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-80 years * Patients with relapsed/advanced HCC (BCLC, stage C) proved by histopathology or proved by CT or MRI imaging system, proven GPC3/NY-ESO-1/AFP(+), relapsed after previous therapy and no effective therapies known at this time. * Life expectancy of ≥ 12 weeks. * WBC\>3.5×10\^9/L, LYMPH\> 0.8×10\^9/L, Hb\>85g/L, PLT\>50×10\^9/L, Cre\<1.5×the upper limit of normal value. * Able to understand and sign the informed consent. Exclusion Criteria: * Any uncontrolled systematic disease: hypertension, heart disease, and et al.; * Portal vein tumor thrombus, central nervous system tumor metastasis, or combined with other tumors; * Receiving radiochemotherapy, local therapy, or targeting drugs within 4 weeks prior to this treatment; * Unstable immune systematic diseases or Infectious diseases; * Combined with AIDS or syphilis; * Patients with history of stem cell or organ transplantation; * Patients with allergic history to related drugs and immunotherapy; * Patients with complications associated with liver diseases: moderate or severe pleural effusion, pericardial effusion, ascites, or gastrointestinal hemorrhage; * Pregnant or lactating subjects; * Unsuitable subjects considered by clinicians.
References
Publications (0)
Data not yet available