Phase 2 Study of Patient-Derived Tumor Tissue Fragment Models for Drug Sensitivity Testing to Guide Personalized Treatment in Advanced Refractory Solid Tumors

What this Trial Is About

Researchers are evaluating a new approach for treating advanced or metastatic refractory solid tumors using patient-derived tumor tissue fragment PDTF models. This phase 2, single-arm, open-label trial involves about 35 patients with cancers that have not responded to previous treatments. The study aims to show that PDTF models can quickly and reliably guide personalized therapy decisions by testing drug sensitivity outside the body, potentially improving precision treatment for difficult cancers. Participants will provide fresh tumor samples obtained through biopsy or surgery. These samples are used to create PDTF models that maintain the tumors original structure and environment. Each model is then exposed to multiple anti-cancer drugs, including chemotherapy, targeted agents, and immunotherapies, all recommended by clinical guidelines. Based on the drug sensitivity results, a personalized treatment plan is developed and given to the patient until disease progression, unacceptable side effects, death, or withdrawal. During the study, patients will be monitored regularly for tumor response, disease control, progression-free survival, and treatment-related side effects. The primary outcome is the objective response rate measured up to three months after enrollment ends. Secondary outcomes include disease control rate, progression-free survival, treatment feasibility, timing, and biopsy-related complications, monitored up to 12 months after the last patient joins. Participants will undergo clinical evaluation, laboratory tests, and imaging to assess their progress throughout the trial.

A Single-arm Clinical Trial Using Patient-derived Tumor Tissue Fragment Models for Drug Sensitivity Testing to Guide Treatment in Previously Treated Cancers