Lung cancer
Conditions
Interventions
Gold Standard:Clinical efficacy: response evaluation criteria in solid tumors (RECIST 1.1) of the National Cancer Institute (NCI) .
Index test:Evaluation of organoid drug sensitivity and specificity in vitro.
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) The subjects voluntarily joined the study and signed the informed consent with good compliance and the cooperable follow-up; 2) The age ranges 18-75; 3) Lung cancers (including non-small cell lung cancer and small cell lung cancer) were confirmed histologically/pathologically, inoperable stage III or IV primary treatment or drug resistant patients; 4) ECOG-PS 0-2, no immunotherapy contraindications such as severe autoimmune disease or severe comorbidities, immune monotherapy or combination chemotherapy were available; 5) Enough samples for organoid culture are available; 6) Survival is expected to be longer than 6 months; 7) Patients may have asymptomatic brain metastases that are well controlled by local treatment (surgery and/or radiotherapy) and do not require hormone maintenance therapy. Palliative radiation therapy of metastatic sites (including brain, bone, and other sites) is permitted without any sustained radiation-related toxicity; 8) Hematological and biochemical indexes are satisfactory; 9) Radiographically evaluable lesions were available, with at least one single-path measurable lesion according to the solid tumor response Evaluation Criteria (RECIST 1.1). Any lesion that has received radiotherapy cannot be used as a target lesion; 10) No clinical evidence of other malignancies, unstable complications, or uncontrolled infections.
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women; or women who are pregnant, nursing, or planning a pregnancy during anti-tumor treatment; 2) Patients with other malignant diseases, severe autoimmune diseases, or other immunotherapy contraindications that require systemic treatment; 3) Current infection difficult to control, with a temperature =38 ° C; 4) Severe heart, lung, kidney, liver, vascular disease, mental illness, or substance abuse; 5) Pathological tissue is unavailabe or organoid models can not be successfully constructed; 6) ECOG-PS 3 or above, no evaluatable lesions, and survival expected to be less than 6 months; 7) Involved in other clinical trials currently underway; 8) Exclusion criteria are not listed while researchers consider unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Consistency of drug sensitivity in vivo and in vitro;Sensitivity and specificity of drug sensitivity evaluation in vitro; | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive predictive value and negative predictive value; | — |
Countries
China
Contacts
Public ContactJiangyong Yu
Beijing Hospital
Outcome results
None listed