Actively Recruiting
Organoids Predict Therapeutic Response in Patients With Multi-line Drug-resistant Lung Cancer
Led by Affiliated Hospital of Jiangnan University · Updated on 2024-03-19
50
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, single-arm, open and exploratory clinical study. The purpose of this study was to evaluate the consistency and accuracy of the organogenic (PDO) model for patients with lung cancer, to predict the clinical efficacy of anticancer drugs, and to speculate and select personalized treatment regiments for patients with lung cancer who are resistant to multi-line standard therapies.
CONDITIONS
Official Title
Organoids Predict Therapeutic Response in Patients With Multi-line Drug-resistant Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older
- Confirmed non-small cell lung cancer by histology or cytology
- Disease progression after multiline standard therapy with no standard protocol recommendation
- Expected survival of at least 3 months
- Signed informed consent
- Willing and able to adhere to the study protocol, including treatment and scheduled visits
- Accessible biopsy or surgery sample of metastasis or primary tumor
- At least one unirradiated measurable lesion (≥10 mm) or unevaluable lesion according to RECIST criteria
You will not qualify if you...
- Participation in other drug clinical trials within four weeks
- Diagnosis of small cell, large cell neuroendocrine, or carcinoid lung cancer
- Inaccessible biopsy or surgery sample
- Insufficient lung tissue for histological or routine pathological analysis
- Uncontrolled heart conditions such as NYHA class 2 or higher heart failure, unstable angina, recent myocardial infarction, or significant arrhythmia requiring treatment
- Women not surgically sterilized or postmenopausal without agreed contraceptive use during and 6 months after treatment; negative pregnancy test and non-nursing
- Men not surgically sterilized or without agreed contraceptive use during and 6 months after treatment
- Active pulmonary tuberculosis or bacterial/fungal infection (≥grade 2), HIV, HBV, or HCV infection
- History of psychotropic substance abuse or mental disorders
- Active or history of autoimmune disease, except certain controlled conditions
- Concomitant diseases posing serious safety risks or affecting study completion as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China, 214000
Actively Recruiting
Research Team
Q
quan liu, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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