eligibility_summary
Eligibility: 16–90, histologically confirmed cancer with failed/no standard therapy, life expectancy >3 mo, KPS≥60 or ECOG 0–2, lesion for TIL harvest and ≥1 evaluable lesion, adequate labs/organ function, fit for biopsy, contraception, stop anticancer therapy ≥28 d pre‑harvest, consent and follow‑up. Exclude: high‑dose steroids/autoimmune, poor lung/major cardiac disease, HIV/HBV/HCV/syphilis, active infection, recent therapy, severe AEs/allergy, pregnancy/lactation, prior transplant, other serious risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase I/II, single-arm study in refractory/metastatic gastric and esophageal cancers testing: 1) Autologous tumor-infiltrating lymphocytes (TILs, biologic cell therapy): patient-derived CD8+/CD4+ T cells expanded ex vivo to recognize tumor antigens via native TCRs. 2) Pembrolizumab (Keytruda, monoclonal antibody): PD-1 checkpoint inhibitor that reverses T‑cell exhaustion and sustains antitumor activity. 3) Lymphodepletion with cyclophosphamide (alkylating agent) and fludarabine (purine analog): reduces endogenous lymphocytes, including Tregs/MDSCs, creating “space” and cytokine availability. 4) Aldesleukin/IL‑2 (cytokine): promotes T‑cell proliferation/survival. Targets/pathways: tumor-reactive T cells in the tumor microenvironment, PD‑1/PD‑L1 axis, IL‑2 receptor/JAK‑STAT signaling, depletion of immunosuppressive cells (Tregs). Primary endpoint: ORR.