Last updated: May 6, 2024
Sponsor: Henan Cancer Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Non-small Cell Lung Cancer
Treatment
Chemotherapy and targeted-therapy guided by organoid drug sensitivity test
Clinical Study ID
NCT06406608
2024-107
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥18 and ≤75 years old (calculated based on the date of signing informed consent);
- Diagnosed as drug-resistant/relapsed non-small cell lung cancer;
- After at least two systemic treatments and the disease progresses;
- According to the efficacy evaluation criteria of solid tumors (RECIST 1.1), at leastone lesion that has not received radiation therapy, has not received other localtherapies, and can obtain tumor tissue (can be from a single lesion source or multiplelesions combined) is used for organoid establishment;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1;
- Expected survival time>3 months;
- Before a tumor sample can be taken, there must be a record of disease progression onimaging after the previous treatment.;
- The patient has informed consent and signed a written consent form;
- The patients had good compliance and willingly followed the study plan, includingscheduled visits, treatments, laboratory tests, and other research steps.
Exclusion
Exclusion Criteria:
- Extremely weakened overall condition, unable to tolerate bronchoscopy examination;
- Patients with acute suppurative inflammation of the respiratory tract accompanied byhigh fever, acute asthma attacks, and ongoing hemoptysis;
- Have a history of interstitial lung disease, non infectious pneumonia or uncontrolledsystemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lungdisease, etc
- Patients with active leptomeningeal disease or brain metastasis;
- Diagnosed with other malignant diseases other than NSCLC within 5 years prior toinitial administration (excluding curative basal cell carcinoma of the skin, squamouscell carcinoma of the skin, and/or curative resection of carcinoma in situ);
- Have a history of immunodeficiency, including positive HIV serum tests;
- Active hepatitis B without treatment (defined as HBsAg positive and HBV-DNA copynumber detected is greater than the upper limit of normal value in the laboratory ofthe research center);
- The presence of any serious or uncontrollable systemic diseases;
- Pregnant or lactating female patients;
- The researchers believe that patients who are not suitable to participate in thisstudy.
Study Design
Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Chemotherapy and targeted-therapy guided by organoid drug sensitivity test
Phase:
Study Start date:
April 16, 2024
Estimated Completion Date:
June 16, 2026
Study Description
Connect with a study center
Henan Cancer Hospital
Zhengzhou, Henan 450003
ChinaActive - Recruiting

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