Actively Recruiting
A Single-arm Clinical Trial Using Patient-derived Tumor Tissue Fragment Models for Drug Sensitivity Testing to Guide Treatment in Refractory Cancers
Led by Qilu Hospital of Shandong University · Updated on 2025-12-04
35
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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 tumor's 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.
CONDITIONS
Brief 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), any gender
- Confirmed diagnosis of refractory malignant solid tumors, including stage IV gastric or gastroesophageal junction adenocarcinoma
- At least one measurable lesion larger than 2 cm suitable for biopsy and PDTF model construction
- No prior systemic treatment or disease progression/recurrence more than 6 months after previous chemotherapy
- ECOG performance status of 0-1 to tolerate biopsy and treatment
- Expected survival of at least 3 months without severe diseases affecting participation
- Adequate organ function including bone marrow, liver, renal, and cardiac criteria
- Women of childbearing potential must use reliable contraception and have a negative pregnancy test before enrollment; men must agree to contraception during and 8 weeks after treatment
- Voluntary participation with signed consent, good compliance, and willingness for follow-up and biological sample provision
You will not qualify if you...
- No available lesions 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 drugs, or immunotherapy
- Uncontrolled cardiovascular or cerebrovascular events, including recent heart failure, angina, myocardial infarction, arrhythmias, stroke, or thrombosis
- Active infections, uncontrolled hypertension, psychiatric disorders, immunodeficiency, or autoimmune diseases
- Active brain or leptomeningeal metastases
- Significant pleural, pericardial effusion, or ascites requiring drainage recently
- Detectable second primary malignant tumor or recent other malignancies
- Major surgery within 28 days or history of allogeneic stem cell or organ transplantation
- Current gastrointestinal diseases or history of unhealed intestinal perforation or fistula
- Live vaccine within 4 weeks prior 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 experimental treatments
- Other serious diseases, laboratory abnormalities, or social factors affecting safety or data collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression, unacceptable toxicity, death, or withdrawal
Participants undergo drug sensitivity testing using patient-derived tumor tissue fragment (PDTF) models from biopsy or surgery samples. Based on the PDTF drug response profiles, an individualized treatment regimen is formulated. Participants then receive the PDTF-guided personalized treatment until disease progression, unacceptable toxicity, death, or withdrawal of consent.
Frequency of treatment visits depends on individual treatment regimen
Duration - Up to 12 months after the last patient is enrolled
Participants are monitored for clinical outcomes, treatment response, adverse events, and biopsy-related complications after treatment ends.
Visits as needed for safety and outcome assessments
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.
J
Jiahui Chu, Ph.D.
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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