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:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT05435768
Eligibility Criteria:
Inclusion Criteria:
1. Aged≥18 years
2. The patients must conform to the advanced solid cancer with multiple metastases(may be accompanied by metastasis of other organs),progression after first-line systemic therapy and have clear pathological diagnosis report
3. The hematopoietic function and general condition of the patients were acceptable(white blood cells \>2.5×10\^9/L,lymphocyte\>0.5 times of normal lower limit，Platelets\>50×10\^9/L）
4. There was no history of serious hematopoietic function, abnormal heart, lung, liver, kidney function and immune deficiency
5. One week before enrollment,absolute value of T lymphocytes≥0.5 times of normal lower limit，neutrophil ≥ 1.0×109/L，AST and ALT ≤3.0 times normal upper limit(Liver cancer/liver metastasis patients ≤5.0 times normal upper limit);creatinine ≤ 3.0 times normal upper limit;serum calcium≥2.0mmol/L
6. Patients's activity status was assessed by Eastern Cooperative Oncology Group(ECOG) score of 0-3,and life expectancy of more than 3 months
7. Abide by the plan during the study period
8. Sign written consent
Exclusion Criteria:
1. Pregnant or lactating women
2. Patinets diagnosed with other malignant disease in the past five years,except for cured skin cancer and cervical carcinoma in situ
3. The clinical severity of uncontrolled epilepsy,central nervous system disease or mental disorder may hinder the signing of informed consent or affect the patient's compliance with medication
4. Sever(i.e. active)heart disease,such an symptomatic coronary heart disease,New York Heart Association(NYHA) class Ⅱ or more severe congestive heart failure or severe arrhythmia requiring drug intervention,or a history of myocardial infraction in the last 12 months；
5. Organ transplantation require immunosuppressive therapy
6. Major active infections are known,or other serious uncontrolled concomitant diseases;endocrine or metabolic disorders,or other serious uncontrolled concomitant diseases;
7. The baseline blood routine did not meet the following criteria:hemoglobin≥90g/L;absolute neutrophil count(ANC)≥1.5×109/L;platelet≥50×109/L;ALT,AST≤2.5 times normal upper limit value;ALP≤2.5 times normal upper limit value; serum total bilirubin\<1.5 times normal upper limit value;Serum creatinine \<3 times normal upper limit value;serum albumin≥30g/L;
8. Anaphylaxis to any research drug ingredients
9. Patients with a history of immunodeficiency,including HIV postive or with other acquired or congenital immunodeficiency disorders,or with a history of organ transplantation,or with other immune-related diseases requiring long-term oral hormone therapy
10. In the period of acute and chronic tuberculosis infection (T-spot test positive,chest X-ray suspicious tuberculosis focus patients)
11. Researchers considered that it was not suitable for other situations in the group
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05435768
Study Brief:
Protocol Section:
NCT05435768