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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
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.
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.
Qilu Hospital of Shandong Univertisy
Jinan, Shandong, China
RECRUITINGObjective Response Rate (ORR)
Proportion of patients achieving a best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 criteria. CR is defined as disappearance of all target lesions and normalization of tumor markers. PR is defined as at least a 30% decrease in the sum of diameters of target lesions compared with baseline.
Time frame: Until 3 months after the last patient is enrolled
Disease Control Rate (DCR)
Proportion of patients whose best overall response is complete response (CR), partial response (PR), or stable disease (SD) according to RECIST v1.1. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
Time frame: Until 3 months after the last patient is enrolled
Progression-Free Survival (PFS)
Time from first dose of PDTF-guided treatment to the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
Time frame: Until 12 months after the last patient is enrolled
Feasibility of PDTF-Guided Treatment
Percentage of patients for whom PDTF model establishment and drug screening are successfully completed
Time frame: Until 1 month after the last patient is enrolled
Time to PDTF-Guided Treatment
Time from receipt of tumor tissue to finalization of a PDTF-guided treatment recommendation
Time frame: Until 1 month after the last patient is enrolled
Treatment-Related Adverse Events
Number and percentage of patients experiencing treatment-related adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, 5.0). Adverse events will be summarized by type, frequency, and severity (Grade 1-5).
Time frame: Until 12 months after the last patient is enrolled
Biopsy-Related Complications
Number and percentage of patients experiencing complications related to tumor biopsy procedures performed for PDTF model establishment (e.g., bleeding, infection, pain requiring intervention, pneumothorax, or other procedure-related adverse events), graded using NCI CTCAE 5.0.
Time frame: Until 12 months after the last patient is enrolled
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