Actively Recruiting
A Single-arm Clinical Trial Using Patient-derived Tumor Tissue Fragment Models for Drug Sensitivity Testing to Guide Treatment in Previously Treated Cancers
Led by Qilu Hospital of Shandong University · Updated on 2025-12-04
35
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Single-arm Clinical Trial Using Patient-derived Tumor Tissue Fragment Models for Drug Sensitivity Testing to Guide Treatment in Previously Treated Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years inclusive
- Confirmed refractory malignant tumors by pathological biopsy, including advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
- Stage IV advanced, recurrent, or metastatic cancer according to TNM staging
- At least one measurable lesion larger than 2 cm suitable for tissue sampling
- No prior systemic treatment or disease progression/recurrence more than 6 months after previous chemotherapy
- ECOG performance status of 0-1
- Expected survival of at least 3 months without severe concomitant diseases
- Adequate organ function: bone marrow, liver, kidney, and cardiac function within specified limits
- Women of childbearing potential must use reliable contraception and have negative pregnancy test; men must use contraception during and 8 weeks after treatment
- Voluntary participation with signed informed consent and willingness to cooperate with follow-up and biological sample collection
You will not qualify if you...
- No lesions available for biopsy or presence of multiple primary malignant tumors
- Severe dysfunction of liver, kidney, heart, or other vital organs
- Poor compliance or contraindications to chemotherapy, targeted therapy, or immunotherapy
- Uncontrolled cardiovascular or cerebrovascular events within specified time frames
- Active infections, uncontrolled hypertension, psychiatric disorders, or conditions affecting safety or efficacy
- Active brain or leptomeningeal metastases
- Significant pleural, pericardial effusion, or ascites requiring drainage recently
- Detectable second primary malignancy or history of other malignancies within 5 years
- Major surgery within 28 days prior to treatment or history of stem cell/organ transplantation
- Current gastrointestinal diseases or history of unhealed perforation or fistula
- Live vaccine within 4 weeks or recent use of herbal or immunomodulatory anticancer drugs
- Pregnant or lactating women or women not using effective contraception
- Current participation in other clinical trials or recent investigational treatments
- Other serious diseases, significant lab abnormalities, or factors affecting safety or data collection as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong Univertisy
Jinan, Shandong, China, 250012
Actively Recruiting
Research Team
L
Lian Liu, M.D., Ph.D.
CONTACT
J
Jiahui Chu, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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