NCT07264803

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, open-label, exploratory clinical trial conducted at Qilu Hospital of Shandong University. Approximately 35 patients with advanced or metastatic refractory cancers will be enrolled. Fresh tumor or metastatic biopsy samples will be collected to establish patient-derived tumor tissue fragment models (PDTFs). Each PDTF will be validated for histologic, molecular, and genetic homology with the original tumor, followed by high-throughput ex vivo drug sensitivity testing using chemotherapy, targeted agents, or immunotherapy drugs and recommended by clinical guidelines. This study aims to demonstrate that the PDTF platform can serve as a rapid, reliable, and clinically relevant tool for precision therapy development and clinical decision-making in refractory cancers, potentially bridging translational models and individualized clinical care.

Conditions

• Solid Tumor Malignancies
• Solid Tumor Cancer

Interventions

Type	Name	Description
OTHER	PDTF-Guided Personalized Treatment	Patients with refractory solid tumors in this arm will undergo drug sensitivity testing using patient-derived tumor tissue fragment (PDTF) models. Fresh tumor tissues obtained from biopsy or surgery will be processed to establish PDTF models that preserve the original tumor architecture and microenvironment. Each PDTF will be exposed ex vivo to a panel of anti-cancer agents, including chemotherapy, targeted therapies, and/or immunotherapy drugs. Based on the PDTF drug response profiles, an individualized treatment regimen will be formulated after obtaining the sensitivity results. Patients will then receive the PDTF-guided regimen until disease progression, unacceptable toxicity, death, or withdrawal of consent. Clinical outcomes and concordance between PDTF sensitivity and in-vivo treatment response will be assessed.
OTHER	PDTF-Guided Personalized Treatment	Patients with refractory solid tumors in this arm will undergo drug sensitivity testing using patient-derived tumor tissue fragment (PDTF) models. Fresh tumor tissues obtained from biopsy or surgery will be processed to establish PDTF models that preserve the original tumor architecture and microenvironment. Each PDTF will be exposed ex vivo to a panel of guideline-recommended, FDA- or NMPA-approved anti-cancer agents, including chemotherapy, targeted therapies, and/or immunotherapy drugs. Based on the PDTF drug response profiles, an individualized treatment regimen will be formulated within 24 hours after obtaining the sensitivity results. Patients will then receive the PDTF-guided regimen until disease progression, unacceptable toxicity, death, or withdrawal of consent. Clinical outcomes and concordance between PDTF sensitivity and in-vivo treatment response will be assessed.

Timeline

• Start date: 2024-03-01
• Primary completion: 2027-12-30
• Completion: 2027-12-30
• First posted: 2025-12-04
• Last updated: 2025-12-04

Locations

1 site across 1 country: China