eligibility_summary
Eligible: Adults 18–70 with unresectable recurrent/metastatic cervical cancer after ≥1 prior systemic therapy, ECOG 0–1, life expectancy ≥12 weeks, adequate organ/marrow function, documented progression before resection, measurable disease by RECIST 1.1 (besides resected lesion), able to consent. Exclude: uncontrolled tumor pain (palliative RT if needed), significant psych/substance abuse, pregnancy/lactation or plans ≤1 year, recent/parallel trials, or other investigator concerns.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase 2 randomized study in recurrent/metastatic cervical cancer comparing: 1) GT101 injection: autologous tumor-infiltrating lymphocytes (TILs), a cellular immunotherapy. Mechanism: patient’s tumor-resident T cells are expanded ex vivo and reinfused to boost tumor-specific immunity, TCR-mediated recognition of tumor/HPV-associated antigens drives cytotoxic killing (perforin/granzyme) and cytokine release (e.g., IFN-γ), aiming to overcome immunosuppression in the tumor microenvironment. 2) Gemcitabine: small-molecule antimetabolite (deoxycytidine analog) chemotherapy, inhibits ribonucleotide reductase and incorporates into DNA, halting DNA synthesis and inducing apoptosis. Targets/pathways: GT101—CD8+/CD4+ T cells, TCR signaling, immune effector pathways in TME, Gemcitabine—proliferating tumor cells, DNA replication (S-phase).