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An evaluation model of immune micro-environment based on micro-fluidic organoid-on-a-chip for clinical lung cancer precision immunotherapy

An evaluation model of immune micro-environment based on micro-fluidic organoid-on-a-chip for clinical lung cancer precision immunotherapy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070858
Enrollment
Unknown
Registered
2023-04-25
Start date
2022-09-28
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Interventions

Modeling group:None
Test group: Obtain puncture tissue for organoid drug sensitivity test, and evaluate the consistency with clinical drug efficacy

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Subjects voluntarily joins the study and signs the informed consent form; 2) 18-75 years old; 3) Patients diagnosed as lung cancer (including NSCLC and small cell lung cancer. such as squamous cell carcinoma, adenocarcinoma and large cell lung cancer) by pathology with inoperable stage III or IV; 4) ECOG-PS score 0-2, patients who have no severe autoimmune diseases, severe complications and other contraindications to immunotherapy and can accept single or combined chemotherapy; 5) Enough samples for organoid culture; 6) Patients with imageable lesions. According to the evaluation criteria of solid tumor efficacy (RECIST 1.1), there is at least one single path measurable lesion.

Exclusion criteria

Exclusion criteria: 1) Other malignant diseases, serious autoimmune diseases or other immunotherapy contraindications that need systematic treatment; 2) Currently uncontrollable infections, the temperature >= 38 ?; 3) The ECOG score >= 3, and the expected survival period less than 6 months 4) Patients who are unable to obtain pathological tissues or whose organoid models have not been successfully constructed; 5) No clinically assessable lesions.

Design outcomes

Primary

MeasureTime frame
Evaluation of clinical efficacy of immunotherapy for solid tumor by iRECIST;Evaluation of organoid drug sensitivity testing;

Secondary

MeasureTime frame
Cytokine and lymphoid subgroup analysis;Genome, transcriptome, and immune microenvironment assessment;

Countries

China

Contacts

Public ContactJiangyong Yu

Beijing Hospital

yujiangyong2011@163.com+86 18610109639

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026