A Single-arm Clinical Trial Using Patient-derived Tumor Tissue Fragment Models for Drug Se
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 fra
| Condition(s) | Solid Tumor Malignancies, Solid Tumor Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 canc |
| Who can participate | Inclusion Criteria Patients must meet all of the following criteria simultaneously to be eligible for enrollment. All criteria must be confirmed through clinical evaluation, laboratory tests, and imaging during the screening period, and approved in writing by the principal investigator. 1. Age between 18 and 75 years (inclusive), regardless of gender. 2. Confirmed diagnosis of refractory malignant tumors via pathological biopsy, including locally advanced unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma; confirmed as stage IV (advanced, recurrent, or metastatic) according to international TNM staging; patients with highly suspected gene mutations or requiring reconfirmation of molecular pathological diagnosis; or patients previously treated at this inst |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Qilu Hospital of Shandong University |
| Locations | Jinan, Shandong, China |
| Start date | 2024-03-01 |
| NCT ID | NCT07264803 |
| Official listing | https://clinicaltrials.gov/study/NCT07264803 |