eligibility_summary
Adults 18–75 with pathology-confirmed advanced/metastatic liver cancer (HCC/CCA BCLC C or B not for local therapy, or unresectable liver mets) after guideline failure (≥1L locally advanced, ≥2L metastatic). Need lesion ≥8 cm³ for TIL, measurable disease, ECOG 0–1, Child‑Pugh ≤7, adequate organs. Excludes pregnancy, severe allergies, transplant, ascites/≥50% liver tumor, uncontrolled brain mets, active HBV/HCV/HIV/TB, serious comorbidities, or recent immunosuppression/therapy/surgery/live vaccine, other cancer.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
NCT06173726 tests BST02, an autologous tumor-infiltrating lymphocyte (TIL) therapy (biologic/cellular immunotherapy) for advanced/metastatic liver cancers (HCC, cholangiocarcinoma, metastatic liver lesions). TILs are expanded from resected tumor and reinfused to kill tumor cells via TCR-mediated recognition of tumor antigens. Supportive interventions: low-dose cyclophosphamide (alkylating chemotherapy) for lymphodepletion to enhance TIL engraftment and reduce regulatory T cells, IL-2 (cytokine) with dose-escalation/expansion to promote T-cell proliferation and survival. Targets/pathways: cytotoxic CD8+ T cells within TILs, tumor microenvironment, IL-2/IL-2R–STAT5 signaling, and reduction of Tregs to boost antitumor immunity.