A Real-World Observational Study of Intratumoral H101 Oncolytic Adenovirus Combined With Immune Checkpoint Inhibitors for Advanced Metastatic Breast Cancer
This prospective, single-center, open-label, real-world observational study plans to enroll 10-15 patients with advanced (Stage IV) breast cancer who have failed multiple prior therapies \[aged 18-75, Eastern Cooperative Oncology Group Performance Status Clinical Classification(ECOG) 0-2, with measurable and injectable lesions\]. It aims to preliminarily evaluate the antitumor activity, safety, and immune-microenvironment modulation of intratumoral H101(Recombinant Human Adenovirus Type 5 Injection) oncolytic virus combined with immune checkpoint inhibitors (ICIs) in real-world practice. The regimen is determined by physicians based on clinical status and multidisciplinary input, but follows a standardized framework: 2- to 3-week cycles; H101 injected on day 1 (dose stratified by lesion size), with ICI infusion started 7±2 days later, for 4 planned cycles. Paired tumor biopsies (when feasible) and peripheral blood are collected at baseline and after 4 cycles for single-cell RNA sequencing and immune profiling, focusing on changes in T lymphocyte (T), Natural Killer cell (NK), dendritic, and macrophage subsets and correlating with clinical outcomes. Primary endpoints include adverse events (Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0(CTCAE v5.0)), objective response and local control rates (Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST 1.1)), 4-cycle completion, and toxicity-related discontinuation. Secondary endpoints include disease control rate, progression-free survival (Kaplan-Meier), and dynamic immune changes. First radiological assessment occurs at 6-8 weeks post-treatment, then every 3 months until progression, loss to follow-up, or 1 year. If re-biopsy is unsafe, only peripheral blood may be collected without protocol violation. Comprehensive follow-up, data confidentiality, and missing-data handling are in place to ensure scientific validity and participant protection.
Age 18 to 75 years, both genders; [+10]
Known allergy to H101 formulation, PD-1 inhibitors, or any of their excipients ; [+11]