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Trial Title:
Patient-derived Organoid Drug Sensitivity Guided Treatment for Recurrent Small Cell Lung Cancer
NCT ID:
NCT06406660
Condition:
Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Chemotherapy and targeted-therapy guided by organoid drug sensitivity test
Description:
This study conducts drug sensitivity tests on various clinically approved drugs. The most
sensitive drug for the patient is selected for treatment. This study aims to evaluate the
clinical effectiveness of treatment plans guided by organoid drug sensitivity tests.
Arm group label:
Organoid-Guided therapy
Summary:
This study plans to enroll 20 patients with recurrent small cell lung cancer.
Patient-derived Organoid will be established, and drug sensitivity test will be conducted
to intervene in the selection of clinical treatment plans. Efficacy evaluation and
prognosis analysis will also be conducted. It is hoped that this study will provide a
basis for the development of personalized treatment plans.
Detailed description:
Twenty patients with recurrent small cell lung cancer who met the inclusion criteria were
enrolled in the study after signing an informed consent form. Tumor samples were obtained
through clinical puncture, and qualified samples were subjected to organoid modeling.
Perform drug sensitivity test on the established lung cancer organoids. The drugs used
are all that have been marketed and applied in clinical practice. According to the
results of organoid drug sensitivity analysis, the patient received a treatment plan with
relatively sensitive drugs. Follow up prognostic data and relevant clinical information
of enrolled patients, conduct statistical analysis on the consistency between drug
sensitivity test results and patient treatment response, and evaluate the clinical
effectiveness of treatment plans guided by organoid drug sensitivity results.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥18 and ≤75 years old (calculated based on the date of signing informed
consent);
2. Diagnosed as recurrent small cell lung cancer;
3. After at least one systematic treatment and the disease progresses;
4. According to the efficacy evaluation criteria of solid tumors (RECIST 1.1), at least
one lesion that has not received radiation therapy, has not received other local
therapies, and can obtain tumor tissue (can be from a single lesion source or
multiple lesions combined) is used for organoid establishment;
5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2;
6. Expected survival time≥3 months;
7. Before a tumor sample can be taken, there must be a record of disease progression on
imaging after the previous treatment.;
8. The patient has informed consent and signed a written consent form;
9. The patients had good compliance and willingly followed the study plan, including
scheduled visits, treatments, laboratory tests, and other research steps.
Exclusion Criteria:
1. Extremely weakened overall condition, unable to tolerate bronchoscopy examination;
2. Patients with acute suppurative inflammation of the respiratory tract accompanied by
high fever, acute asthma attacks, and ongoing hemoptysis;
3. Have a history of interstitial lung disease, non infectious pneumonia or
uncontrolled systemic diseases, including diabetes, hypertension, pulmonary
fibrosis, acute lung disease, etc
4. Patients with active leptomeningeal disease or brain metastasis;
5. Diagnosed with other malignant diseases other than NSCLC within 5 years prior to
initial administration (excluding curative basal cell carcinoma of the skin,
squamous cell carcinoma of the skin, and/or curative resection of carcinoma in
situ);
6. Have a history of immunodeficiency, including positive HIV serum tests;
7. Active hepatitis B without treatment (defined as HBsAg positive and HBV-DNA copy
number detected is greater than the upper limit of normal value in the laboratory of
the research center);
8. The presence of any serious or uncontrollable systemic diseases;
9. Pregnant or lactating female patients;
10. The researchers believe that patients who are not suitable to participate in this
study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Recruiting
Contact:
Last name:
Qiming Wang, PhD
Phone:
+8613783590691
Email:
qimingwang1006@126.com
Start date:
April 16, 2024
Completion date:
June 16, 2026
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Kingbio Medical (Beijing) Co., Ltd.
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06406660
