Actively Recruiting
Patient-derived Tumor-like Cell Cluster Model-based Precision Treatment Strategy on Non-small Cell Lung Cancer
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2026-01-09
250
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is a prospective, observational study of non-small cell lung cancer that aims to evaluate the feasibility, preliminary efficacy and safety of patient-derived tumor-like cell cluster model in guiding the precision treatment strategy.
CONDITIONS
Official Title
Patient-derived Tumor-like Cell Cluster Model-based Precision Treatment Strategy on Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Diagnosed with non-small cell lung cancer confirmed by pathology (histology or cytology)
- Have measurable tumor lesions per RECIST 1.1 criteria: tumor lesion long diameter 10mm or lymph node lesion short diameter 15mm, with scanning layer thickness 5mm
- Tumor lesions have not received local treatments such as radiotherapy or cryotherapy
- ECOG performance status score of 0 to 2
- Expected survival of at least 3 months
- Adequate liver function with total bilirubin 1.5 times upper limit of normal (ULN) and AST/ALT 2.5 times ULN
- Adequate kidney function with creatinine clearance 50 ml/min (Cockcroft-Gault formula)
- Adequate blood clotting function with INR or PT 1.5 times ULN; if on anticoagulants, values must be within therapeutic range
- For women of childbearing potential, negative pregnancy test within 3 days before first treatment dose
- Use of highly effective contraception for at least 180 days after trial treatment if at risk of conception; abstinence accepted if usual method
- Voluntary enrollment with signed informed consent and compliance with follow-up visits
You will not qualify if you...
- Currently in another interventional clinical treatment study or received investigational drug/device within 4 weeks before first dose
- Received anti-tumor proprietary medicine or immunomodulatory drugs within 2 weeks before first dose or major surgery within 3 weeks before first dose
- Active bleeding from lungs, diverticulitis, abdominal abscess, gastrointestinal obstruction, or peritoneal metastases needing clinical intervention
- Active central nervous system metastases or carcinomatous meningitis
- Prior solid organ or blood system transplant
- Class III-IV congestive heart failure with poorly controlled arrhythmias
- Recent arterial thrombosis, embolism, ischemia, or serious thromboembolism within defined recent months
- Active autoimmune disease requiring systemic therapy within 2 years before first dose
- Need for long-term systemic corticosteroids; intermittent inhaled corticosteroids or bronchodilators allowed
- Other malignancy diagnosed within 5 years prior to first dose except certain skin cancers or carcinoma in situ
- Psychiatric or substance abuse conditions impacting compliance
- Known HIV, syphilis, or active tuberculosis infection
- Untreated active hepatitis B or active hepatitis C infection
- Live vaccine received within 30 days before first dose (inactivated flu vaccine allowed)
- Abnormal medical history, disease, or labs interfering with study participation or safety
- Local or systemic disease or cancer reactions posing high medical risk or survival evaluation uncertainty
- Investigator judged unsuitability for inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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