Patient-derived Organoid Drug Sensitivity Guided Treatment for Drug-resistant Recurrent Non-Small Cell Lung Cancer

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

This study aims to enroll non-small cell lung cancer patients who have undergone at least two rounds of standard treatment for drug resistance/recurrence. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 and ≤75 years old (calculated based on the date of signing informed consent);
  2. Diagnosed as drug-resistant/relapsed non-small cell lung cancer;
  3. After at least two systemic treatments and the disease progresses;
  4. 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;
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1;
  6. Expected survival time>3 months;
  7. Before a tumor sample can be taken, there must be a record of disease progression onimaging 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, includingscheduled visits, treatments, laboratory tests, and other research steps.

Exclusion

Exclusion Criteria:

  1. Extremely weakened overall condition, unable to tolerate bronchoscopy examination;
  2. Patients with acute suppurative inflammation of the respiratory tract accompanied byhigh fever, acute asthma attacks, and ongoing hemoptysis;
  3. Have a history of interstitial lung disease, non infectious pneumonia or uncontrolledsystemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lungdisease, etc
  4. Patients with active leptomeningeal disease or brain metastasis;
  5. 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);
  6. Have a history of immunodeficiency, including positive HIV serum tests;
  7. 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);
  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 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

Twenty patients with drug-resistant/relapsed non-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.

Connect with a study center

  • Henan Cancer Hospital

    Zhengzhou, Henan 450003
    China

    Active - Recruiting

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