Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT06537505
Eligibility Criteria:
Inclusion Criteria:
1. Patients with clinically confirmed advanced non-small cell lung cancer or hepatocellular carcinoma;
2. Previously received systemic treatment;
3. Expected survival period \> 3 months;
4. Age: 18-75 years old, male or female;
5. ECOG PS: 0-2 points;
6. The function of important organs meets the following requirements: a) Absolute neutrophil count ≥1.5×109/L, platelet ≥90×109/L, hemoglobin ≥90g/dL; b) Bilirubin ≤3 times ULN (patients drained by retrograde technique can be included); ALT and AST ≤5 times ULN, albumin\>35g/ml, prothrombin time prolonged \<6 seconds; c) Creatinine \<120 μmol/L, or MDRD creatinine clearance \>60 mL/min;
7. Women of childbearing age must have a negative pregnancy test (βHCG) before starting treatment, and women of childbearing age and men (having sexual relations with women of childbearing age) must agree to use effective contraceptive measures uninterruptedly during treatment and for 6 months after the last treatment dose;
8. The patient voluntarily joined this study and signed the informed consent form.
Exclusion Criteria:
1. Patients who have had other malignant tumors in the past or at the same time within 5 years, but excluding cured basal cell carcinoma of the skin, cervical carcinoma in situ, superficial or non-invasive bladder cancer, etc.
2. Patients with severe bleeding tendency and coagulation dysfunction that cannot be corrected in the short term;
3. Patients with severe pulmonary fibrosis and pulmonary hypertension;
4. Patients with infectious and radioactive inflammation around the lesion and skin infection at the puncture site that is not well controlled;
5. Systemic infection, high fever \>38.5 ℃;
6. Severe anemia, dehydration and severe nutritional metabolism disorder that cannot be corrected or improved in a short period of time;
7. Poorly controlled malignant pleural effusion;
8. Uncontrolled, symptomatic brain metastasis or a history of difficult-to-control mental illness or severe intellectual or cognitive impairment;
9. Subjects with active, known or suspected autoimmune diseases, hypothyroidism that only requires hormone replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia) can be selected;
10. Congestive heart failure, uncontrollable arrhythmias, myocardial infarction within 6 months, unstable angina, stroke or transient ischemic attack;
11. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up;
12. History of psychotropic drug abuse, alcoholism or drug abuse;
13. Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive;
14. Those who are considered by the researchers to be unsuitable for participation in this trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06537505
Study Brief:
Protocol Section:
NCT06537505